Trial Outcomes & Findings for Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) (NCT NCT02626455)
NCT ID: NCT02626455
Last Updated: 2024-12-11
Results Overview
Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting \>7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
551 participants
Primary outcome timeframe
At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
Results posted on
2024-12-11
Participant Flow
SRI part screened 42 participants from 12 countries, between 06-Jan-2016 (first participants first visit \[FPFV\]) and 31-Oct-2019 (last participant first visit \[LPFV\]). Phase 3 part screened 672 participants from 35 countries/regions, between 06-Feb-2017 (FPFV) and 31-Mar-2020(LPFV). Study terminated on 10-Nov-2023,
SRI: 42 participants were screened, 15 participants discontinued screening, 27 participants were enrolled and administered treatment. Phase 3: 672 participants were screened, 148 discontinued screening. 524 participants were enrolled and randomized to treatment. 4 participants were randomized but never administered, 520 participants were randomized and administered treatment.
Participant milestones
| Measure |
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
|
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
5
|
6
|
6
|
262
|
262
|
|
Overall Study
COMPLETED
|
0
|
2
|
3
|
2
|
3
|
108
|
153
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
2
|
4
|
3
|
154
|
109
|
Reasons for withdrawal
| Measure |
SRI: Copa+R-B 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
Phase 3: Copa+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
|
Phase 3: Pbo+R-B/R-CHOP
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
17
|
23
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
10
|
6
|
|
Overall Study
Physician Decision
|
0
|
2
|
2
|
2
|
1
|
10
|
3
|
|
Overall Study
Patient decision: COVID-19 pandemic related
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician decision: COVID-19 pandemic related
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Logistical reason: COVID-19 pandemic related
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Patient decision
|
0
|
1
|
0
|
0
|
1
|
36
|
22
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Progressive disease - radiological progression
|
0
|
0
|
0
|
0
|
0
|
11
|
22
|
|
Overall Study
Progressive disease - clinical progression
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
AE not associated with clinical disease progression
|
1
|
1
|
0
|
2
|
1
|
65
|
21
|
|
Overall Study
AE associated with clinical disease progression
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Study intervention never administered
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
Baseline Characteristics
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Baseline characteristics by cohort
| Measure |
SRI: Copa+R-B 45 mg
n=3 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 Participants
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
Phase 3: Copa+R-B/R-CHOP
n=262 Participants
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
|
Phase 3: Pbo+R-B/R-CHOP
n=262 Participants
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
|
Total
n=551 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
160 Participants
n=8 Participants
|
162 Participants
n=8 Participants
|
340 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
102 Participants
n=8 Participants
|
100 Participants
n=8 Participants
|
211 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
128 Participants
n=8 Participants
|
246 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
159 Participants
n=8 Participants
|
134 Participants
n=8 Participants
|
305 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
56 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
223 Participants
n=8 Participants
|
215 Participants
n=8 Participants
|
464 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
189 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
144 Participants
n=8 Participants
|
168 Participants
n=8 Participants
|
328 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOPDose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting \>7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=3 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 Participants
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
SRI: Occurrence of Dose-limiting Toxicities (DLT)
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
16.7 Percentage
|
PRIMARY outcome
Timeframe: Approximately 6 years 4 monthsPFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Progression-free Survival (PFS) by Independent Central Review
|
32.9 Months
Interval 24.4 to 38.6
|
33.3 Months
Interval 27.8 to 42.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 7 years 8 monthsBest overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=3 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 Participants
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
SRI: Best Overall Response
BR - Minor response (MR)
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
BR - Stable disease
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
20.0 Percentage
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
Best response (BR) -Complete response (CR)
|
33.3 Percentage
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
71.4 Percentage
95% Confidence Interval 29.0 • Interval 29.0 to 96.3
|
60.0 Percentage
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
16.7 Percentage
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
50.0 Percentage
95% Confidence Interval 11.8 • Interval 11.8 to 88.2
|
|
SRI: Best Overall Response
BR - Very good partial response (VGPR)
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
BR - Partial response (PR)
|
66.7 Percentage
95% Confidence Interval 9.4 • Interval 9.4 to 99.2
|
28.6 Percentage
95% Confidence Interval 3.7 • Interval 3.7 to 71.0
|
20.0 Percentage
95% Confidence Interval 0.5 • Interval 0.5 to 71.6
|
83.3 Percentage
95% Confidence Interval 35.9 • Interval 35.9 to 99.6
|
33.3 Percentage
95% Confidence Interval 4.3 • Interval 4.3 to 77.7
|
|
SRI: Best Overall Response
BR - Progressive disease (PD)
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
BR - Unconfirmed early stable disease (uSD)
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
BR - Not evaluable
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
16.7 Percentage
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
|
SRI: Best Overall Response
BR - Not available
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
0 Percentage
95% Confidence Interval 0 • Interval 0.0 to 0.0
|
|
SRI: Best Overall Response
Response rate - Objective response rate (ORR)
|
100.0 Percentage
95% Confidence Interval 29.2 • Interval 29.2 to 100.0
|
100.0 Percentage
95% Confidence Interval 59.0 • Interval 59.0 to 100.0
|
80.0 Percentage
95% Confidence Interval 28.4 • Interval 28.4 to 99.5
|
100.0 Percentage
95% Confidence Interval 54.1 • Interval 54.1 to 100.0
|
83.3 Percentage
95% Confidence Interval 35.9 • Interval 35.9 to 99.6
|
|
SRI: Best Overall Response
Response rate - Disease control rate (DCR)
|
100.0 Percentage
95% Confidence Interval 29.2 • Interval 29.2 to 100.0
|
100.0 Percentage
95% Confidence Interval 59.0 • Interval 59.0 to 100.0
|
100.0 Percentage
95% Confidence Interval 47.8 • Interval 47.8 to 100.0
|
100.0 Percentage
95% Confidence Interval 54.1 • Interval 54.1 to 100.0
|
83.3 Percentage
95% Confidence Interval 35.9 • Interval 35.9 to 99.6
|
|
SRI: Best Overall Response
Response rate - Complete response rate (CRR)
|
33.3 Percentage
95% Confidence Interval 0.8 • Interval 0.8 to 90.6
|
71.4 Percentage
95% Confidence Interval 29.0 • Interval 29.0 to 96.3
|
60.0 Percentage
95% Confidence Interval 14.7 • Interval 14.7 to 94.7
|
16.7 Percentage
95% Confidence Interval 0.4 • Interval 0.4 to 64.1
|
50.0 Percentage
95% Confidence Interval 11.8 • Interval 11.8 to 88.2
|
SECONDARY outcome
Timeframe: Approximately 4 years 10 monthsA treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=3 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 Participants
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any TEAE
|
3 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
TESAEs
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 years 4 monthsORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review
|
85.5 Percentage
95% Confidence Interval 80.6 • Interval 80.6 to 89.5
|
86.6 Percentage
95% Confidence Interval 81.9 • Interval 81.9 to 90.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 years 4 monthsORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: ORR-Investigator Assessment
|
85.5 Percentage
95% Confidence Interval 80.6 • Interval 80.6 to 89.5
|
86.6 Percentage
95% Confidence Interval 81.9 • Interval 81.9 to 90.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsDOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=224 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=227 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Duration of Tumor Response (DOR)-Independent Central Review
|
32.2 Months
95% Confidence Interval 22.8 • Interval 22.8 to 38.8
|
32.4 Months
95% Confidence Interval 27.7 • Interval 27.7 to 42.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsDOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=227 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=229 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: DOR-Investigator Assessment
|
32.4 Months
Interval 24.3 to 38.8
|
30.9 Months
Interval 24.8 to 42.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsCRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review
|
38.5 Percentage
95% Confidence Interval 32.6 • Interval 32.6 to 44.7
|
41.2 Percentage
95% Confidence Interval 35.2 • Interval 35.2 to 47.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsCRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: CRR-Investigator Assessment
|
39.7 Percentage
Interval 33.7 to 45.9
|
42.0 Percentage
Interval 35.9 to 48.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsDCR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Disease Control Rate (DCR)-Independent Central Review
|
88.5 Percentage
95% Confidence Interval 84.1 • Interval 84.1 to 92.1
|
92.4 Percentage
95% Confidence Interval 88.5 • Interval 88.5 to 95.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsDCR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: DCR-Investigator Assessment
|
88.5 Percentage
95% Confidence Interval 84.1 • Interval 84.1 to 92.1
|
92.4 Percentage
95% Confidence Interval 88.5 • Interval 88.5 to 95.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsTTP, as assessed by independent central review, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Time to Tumor Progression (TTP)-Independent Central Review
|
36.1 Months
95% Confidence Interval 30.3 • Interval 30.3 to 44.0
|
35.0 Months
95% Confidence Interval 30.4 • Interval 30.4 to 44.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsTTP, as assessed by investigator, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of "other" as reason (which excludes PD).
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: TTP-Investigator Assessment
|
36.1 Months
95% Confidence Interval 30.3 • Interval 30.3 to 44.0
|
35.0 Months
95% Confidence Interval 30.4 • Interval 30.4 to 44.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsA new anti-lymphoma therapy is any new systemic anticancer treatment or radiotherapy for lymphoma, with a consolidation intent. TTNT was defined as the time from the date of randomization to the start of new anti-lymphoma therapy, where the date of randomization was considered Day 1.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Time to Next Anti-lymphoma Treatment (TTNT)
|
NA Months
Interval 50.1 to
NA: Value cannot be estimated due to censored data, insufficient number of participants with events.
|
NA Months
NA: Value cannot be estimated due to censored data, insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsOverall survival is defined as the time from randomization until death from any cause. The OS for patients alive at the time of the database cut-off date was censored to the last date they were known to be alive. Deaths that occurred after the database cut-off date, reported during data cleaning, were considered for establishing the last known alive date at data cut-off.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Overall Survival (OS)
|
NA Months
NA: Value cannot be estimated due to censored data, insufficient number of participants with events.
|
NA Months
NA: Value cannot be estimated due to censored data, insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsTime to deterioration in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated in all patients. It is defined as the time from randomization to DRS-P decline, progression, or death from any reason, whichever occurred earlier.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Time to Deterioration in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
|
2.7 Months
95% Confidence Interval 1.9 • Interval 1.9 to 3.3
|
6.3 Months
95% Confidence Interval 4.6 • Interval 4.6 to 8.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 years 4 monthsTime to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated for all patients. It is defined as the time from randomization to DRS-P improvement of at least 3 points.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=262 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=262 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Time to Improvement in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
|
12.8 Months
95% Confidence Interval 6.7 • Interval 6.7 to 36.1
|
5.1 Months
95% Confidence Interval 2.8 • Interval 2.8 to 8.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 4 yearsA treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.
Outcome measures
| Measure |
SRI: Copa+R-B 45 mg
n=263 Participants
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=257 Participants
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
In SRI part, participants received copanlisib at dose level of 45 mg in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
In SRI part, participants received copanlisib at dose level of 60 mg in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
In SRI part, participants from Japan received copanlisib at dose level of 60 mg in combination with R-B.
|
|---|---|---|---|---|---|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any TEAE
|
263 Participants
|
250 Participants
|
—
|
—
|
—
|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
TESAEs
|
161 Participants
|
54 Participants
|
—
|
—
|
—
|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any copanlisib or placebo related TEAE
|
250 Participants
|
214 Participants
|
—
|
—
|
—
|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any copanlisib or placebo related TESAEs
|
118 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any R-B/R-CHOP related TEAE
|
245 Participants
|
224 Participants
|
—
|
—
|
—
|
|
Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Any R-B/R-CHOP related TESAEs
|
109 Participants
|
26 Participants
|
—
|
—
|
—
|
Adverse Events
SRI: Copa+R-B 45 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
SRI: Copa+R-CHOP 45 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
SRI: Copa+R-CHOP 60 mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
SRI: Japan Copa+R-B 60 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 3: Copa+R-B/R-CHOP
Serious events: 161 serious events
Other events: 259 other events
Deaths: 68 deaths
Phase 3: Pbo+R-B/R-CHOP
Serious events: 54 serious events
Other events: 250 other events
Deaths: 62 deaths
Serious adverse events
| Measure |
SRI: Copa+R-B 45 mg
n=3 participants at risk
In SRI part, subjects received 45 mg of copanlisib in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 participants at risk
In SRI part, subjects received 60 mg of copanlisib in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 participants at risk
In SRI part, subjects received 45 mg of copanlisib in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 participants at risk
In SRI part, subjects received 60 mg of copanlisib in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 participants at risk
In SRI part, Subjects from Japan only received 60 mg of copanlisib in combination with R-B.
|
Phase 3: Copa+R-B/R-CHOP
n=263 participants at risk
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
|
Phase 3: Pbo+R-B/R-CHOP
n=257 participants at risk
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.8%
18/263 • Number of events 18 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.1%
8/257 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Chills
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.4%
22/263 • Number of events 26 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Inflammation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.6%
12/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Disseminated cryptococcosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
12.9%
34/263 • Number of events 38 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Varicella
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumococcal sepsis
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Infective thrombosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Viraemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/263 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Norovirus test positive
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.8%
10/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Coma
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/263 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
Other adverse events
| Measure |
SRI: Copa+R-B 45 mg
n=3 participants at risk
In SRI part, subjects received 45 mg of copanlisib in combination with R-B.
|
SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)
n=7 participants at risk
In SRI part, subjects received 60 mg of copanlisib in combination with R-B.
|
SRI: Copa+R-CHOP 45 mg
n=5 participants at risk
In SRI part, subjects received 45 mg of copanlisib in combination with R-CHOP.
|
SRI: Copa+R-CHOP 60 mg
n=6 participants at risk
In SRI part, subjects received 60 mg of copanlisib in combination with R-CHOP.
|
SRI: Japan Copa+R-B 60 mg
n=6 participants at risk
In SRI part, Subjects from Japan only received 60 mg of copanlisib in combination with R-B.
|
Phase 3: Copa+R-B/R-CHOP
n=263 participants at risk
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to copanlisib + R-B. Participants who received R-B as a previous line of therapy were randomized to copanlisib + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to copanlisib + R-B.
|
Phase 3: Pbo+R-B/R-CHOP
n=257 participants at risk
In Phase 3 part, participants who never received R-B as a previous line of therapy were randomized to placebo + R-B. Participants who received R-B as a previous line of therapy were randomized to placebo + R-CHOP or, if progression-free interval after the last R-B treatment was ≥ 24 months, to placebo + R-B.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
32.3%
85/263 • Number of events 166 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
24.9%
64/257 • Number of events 147 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 9 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.9%
13/263 • Number of events 18 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.2%
21/257 • Number of events 39 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.7%
15/263 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.6%
22/257 • Number of events 42 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
71.4%
5/7 • Number of events 24 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
80.0%
4/5 • Number of events 20 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
32.7%
86/263 • Number of events 213 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
34.2%
88/257 • Number of events 232 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
44/263 • Number of events 68 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
10.9%
28/257 • Number of events 57 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.3%
14/263 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.4%
14/257 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.6%
12/263 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.1%
13/257 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
60.0%
3/5 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
13.7%
36/263 • Number of events 43 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
19.1%
49/257 • Number of events 57 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
60.0%
3/5 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
66.7%
4/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.5%
88/263 • Number of events 137 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.8%
38/257 • Number of events 45 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.1%
8/257 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.1%
16/263 • Number of events 21 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
71.4%
5/7 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
60.0%
3/5 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
66.7%
4/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.6%
112/263 • Number of events 208 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
35.8%
92/257 • Number of events 156 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
57.1%
4/7 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.5%
25/263 • Number of events 31 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.9%
10/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
22.4%
59/263 • Number of events 123 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
12.1%
31/257 • Number of events 44 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.8%
18/263 • Number of events 20 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.2%
21/257 • Number of events 28 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Chills
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.8%
18/263 • Number of events 24 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/257 • Number of events 9 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Face oedema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
19.4%
51/263 • Number of events 65 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
19.1%
49/257 • Number of events 63 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.9%
26/263 • Number of events 47 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.8%
15/257 • Number of events 26 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Oedema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
57.1%
4/7 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.1%
87/263 • Number of events 130 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
13.2%
34/257 • Number of events 51 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
General disorders
Swelling face
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.3%
14/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
17.9%
47/263 • Number of events 70 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.4%
14/257 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.9%
13/263 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.8%
15/257 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.3%
14/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.3%
11/257 • Number of events 15 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 9 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.8%
10/263 • Number of events 12 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
11.8%
31/263 • Number of events 34 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.5%
9/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
44/263 • Number of events 63 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.4%
37/257 • Number of events 51 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
7.2%
19/263 • Number of events 32 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.6%
17/257 • Number of events 22 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.3%
14/263 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Device related sepsis
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.8%
15/257 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.4%
38/263 • Number of events 62 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.6%
22/257 • Number of events 38 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.9%
13/263 • Number of events 15 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.9%
10/257 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
12.9%
34/263 • Number of events 51 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
7.0%
18/257 • Number of events 27 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
7.2%
19/263 • Number of events 33 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.1%
13/257 • Number of events 27 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.6%
12/263 • Number of events 23 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.4%
14/257 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
10.3%
27/263 • Number of events 53 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.3%
11/257 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.1%
16/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.7%
15/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 9 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.8%
18/263 • Number of events 21 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.1%
13/257 • Number of events 18 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
66.7%
4/6 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
27.4%
72/263 • Number of events 232 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
19.5%
50/257 • Number of events 145 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
41.4%
109/263 • Number of events 489 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
31.9%
82/257 • Number of events 301 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
27.4%
72/263 • Number of events 209 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.2%
52/257 • Number of events 126 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
24.3%
64/263 • Number of events 74 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.2%
21/257 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
29.7%
78/263 • Number of events 386 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
25.3%
65/257 • Number of events 272 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
7.6%
20/263 • Number of events 28 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.1%
13/257 • Number of events 22 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
7.6%
20/263 • Number of events 28 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Investigations
Norovirus test positive
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
85.7%
6/7 • Number of events 15 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
100.0%
5/5 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
66.7%
4/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
57.0%
150/263 • Number of events 318 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.6%
53/257 • Number of events 145 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.9%
26/263 • Number of events 40 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.6%
17/257 • Number of events 24 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.2%
21/257 • Number of events 34 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.9%
13/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.2%
11/263 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
44/263 • Number of events 62 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.5%
9/257 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.1%
24/263 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.1%
8/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
42.9%
3/7 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.3%
43/263 • Number of events 54 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
12.5%
32/257 • Number of events 40 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.8%
15/257 • Number of events 20 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.2%
11/263 • Number of events 12 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.9%
23/257 • Number of events 31 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
6.8%
18/263 • Number of events 22 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.7%
12/257 • Number of events 17 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 21 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.9%
10/257 • Number of events 11 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
13.3%
35/263 • Number of events 44 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
11.3%
29/257 • Number of events 42 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.6%
4/257 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
8.7%
23/263 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.1%
13/257 • Number of events 13 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/257 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/263 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
40.0%
2/5 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
15.6%
41/263 • Number of events 59 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.4%
37/257 • Number of events 47 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
33.3%
2/6 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.3%
14/263 • Number of events 15 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.3%
11/257 • Number of events 12 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 4 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.9%
5/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.4%
9/263 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.2%
11/263 • Number of events 12 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.9%
10/257 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 14 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.2%
3/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.39%
1/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/263 • Number of events 7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/257 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.1%
3/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.38%
1/263 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
11.4%
30/263 • Number of events 39 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.3%
24/257 • Number of events 29 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
57.1%
4/7 • Number of events 8 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
22.4%
59/263 • Number of events 75 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
10.1%
26/257 • Number of events 33 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
9.5%
25/263 • Number of events 38 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
5.4%
14/257 • Number of events 16 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
1.5%
4/263 • Number of events 5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
28.6%
2/7 • Number of events 10 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
80.0%
4/5 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
43.3%
114/263 • Number of events 328 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.3%
42/257 • Number of events 90 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
14.3%
1/7 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
16.7%
1/6 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
3.0%
8/263 • Number of events 18 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.7%
7/257 • Number of events 9 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
4.2%
11/263 • Number of events 12 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
2.3%
6/257 • Number of events 6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Secondary hypertension
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
20.0%
1/5 • Number of events 1 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/263 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/257 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/7 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/5 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.00%
0/6 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
50.0%
3/6 • Number of events 3 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.76%
2/263 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
0.78%
2/257 • Number of events 2 • After the first study intervention up to 30 days after the end of study intervention. For SRI, this is over a period of approximately 4 years 10 months and for phase 3, over a period of approximately 4 years.
Adverse event reporting, for the all-cause mortality, considers all deaths that occurred at any time during the study before the last contact. For SRI, up to 7 years 8 months. For phase 3, up to 6 years 4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60