Trial Outcomes & Findings for A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors (NCT NCT05159388)
NCT ID: NCT05159388
Last Updated: 2026-06-16
Results Overview
Phase 1: Dose-limiting toxicities (DLTs) over the first 28-days of study treatment
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
28 days
Results posted on
2026-06-16
Participant Flow
Participant milestones
| Measure |
PRS-344/S095012 12mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 80mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
PRS-344/S095012 and Obinutuzumab
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
14
|
6
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
14
|
4
|
13
|
Reasons for withdrawal
| Measure |
PRS-344/S095012 12mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 80mg
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
PRS-344/S095012 and Obinutuzumab
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal Of Consent
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Death Due To Progressive Disease
|
2
|
5
|
12
|
2
|
6
|
|
Overall Study
Death Due To Other Causes
|
1
|
0
|
2
|
1
|
2
|
|
Overall Study
Other
|
1
|
2
|
0
|
0
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=13 Participants
PRS-344/S095012 and Obinutuzumab
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 10.10 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 8.81 • n=9 Participants
|
59.4 years
STANDARD_DEVIATION 14.67 • n=14 Participants
|
53.8 years
STANDARD_DEVIATION 8.84 • n=6 Participants
|
62.7 years
STANDARD_DEVIATION 13.28 • n=13 Participants
|
59.8 years
STANDARD_DEVIATION 12.21 • n=46 Participants
|
|
Age, Customized
<65 years
|
3 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=14 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=13 Participants
|
28 Participants
n=46 Participants
|
|
Age, Customized
≥65 years
|
1 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=13 Participants
|
18 Participants
n=46 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=14 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=13 Participants
|
21 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=14 Participants
|
3 Participants
n=6 Participants
|
10 Participants
n=13 Participants
|
25 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 28 daysPopulation: This is based on the DLT Evaluable Set which was defined as all participants who received at least 80% of the required Cycle 1 PRS-344/S095012 dose and completed the DLT observation period or who experienced a DLT.
Phase 1: Dose-limiting toxicities (DLTs) over the first 28-days of study treatment
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=3 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=7 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=10 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Safety Measurements: Number of Participants With at Least One DLT in the First 28-days of Treatment
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: This is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
Phase 1: Adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Safety Measurements: Number of Participants With at Least One AE
|
6 Participants
|
12 Participants
|
4 Participants
|
9 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: This is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
Phase 1: Discontinuation of study treatment due to an AE
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Safety Measurements: Number of Participants With at Least One AE Leading to Treatment Discontinuation
|
2 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle was 28 days)Population: The number analyzed in rows differs due to missing participant data. This is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
Phase 1
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Mean PRS-344/S095012 Concentrations at the End of the Infusion
Cycle 1 Day 1
|
22022.9 ng/mL
Standard Deviation 3533.0
|
9884.4 ng/mL
Standard Deviation 2245.4
|
3703.3 ng/mL
Standard Deviation 1627.2
|
10169.3 ng/mL
Standard Deviation 1222.7
|
18843.0 ng/mL
Standard Deviation 4836.7
|
|
Mean PRS-344/S095012 Concentrations at the End of the Infusion
Cycle 2 Day 1
|
12292.2 ng/mL
Standard Deviation 8914.1
|
8118.0 ng/mL
Standard Deviation 2319.4
|
2542.7 ng/mL
Standard Deviation 1963.5
|
5927.5 ng/mL
Standard Deviation 3534.7
|
8961.4 ng/mL
Standard Deviation 10780.9
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 5 Day 1, Cycle 5 Day 15, Cycle 6 Day 1 (each cycle was up to 28 days)Population: The number analyzed in rows differs due to missing participant data. This is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
Phase 1
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 1 Day 1
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
2.3 ng/mL
Standard Deviation 8.6
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 1 Day 15
|
6.3 ng/mL
Standard Deviation 6.2
|
64.7 ng/mL
Standard Deviation 191.4
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
2.5 ng/mL
Standard Deviation 5.0
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 2 Day 1
|
0.0 ng/mL
Standard Deviation 0.0
|
2.9 ng/mL
Standard Deviation 7.1
|
0.0 ng/mL
Standard Deviation 0.0
|
0.9 ng/mL
Standard Deviation 2.2
|
1.1 ng/mL
Standard Deviation 3.2
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 2 Day 15
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
1.3 ng/mL
Standard Deviation 2.9
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 3 Day 1
|
0.0 ng/mL
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
3.0 ng/mL
Standard Deviation 5.9
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 3 Day 15
|
0.0 ng/mL
|
0.0 ng/mL
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 4 Day 1
|
0.0 ng/mL
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 4 Day 15
|
—
|
0.0 ng/mL
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 5 Day 1
|
—
|
0.0 ng/mL
|
—
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 5 Day 15
|
—
|
0.0 ng/mL
|
—
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
|
|
Mean PRS-344/S095012 Trough Concentrations (Ctrough)
Cycle 6 Day 1
|
—
|
0.0 ng/mL
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
|
SECONDARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: Immunogenicity Set is defined as all participants who received at least one dose of IMP (PRS-344/S095012) and have baseline and at least one post-baseline (pre-infusion) immunogenicity assessment.
Phase 1
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=5 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=9 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=8 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=13 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Positive Anti-drug Antibody (ADA) Titer Result PRS-344/S095012
|
4 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: Response Evaluable Set was defined as all participants in the treated set who had measurable disease at baseline and met any of the following conditions: 1) at least one post-baseline disease assessment; 2) documented clinical progression; 3) death.
Phase 1: Defined as Complete Response (CR) plus Partial Response (PR), per investigator assessment
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=10 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=8 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Percentage of participants
Interval 0.0 to 39.0
|
10.0 Percentage of participants
Interval 1.8 to 40.4
|
0 Percentage of participants
Interval 0.0 to 49.0
|
0 Percentage of participants
Interval 0.0 to 32.4
|
0 Percentage of participants
Interval 0.0 to 21.5
|
SECONDARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: Treated Set was defined as all participants who received at least one dose of IMP (PRS-344/S095012)
Phase 1: The best response across visits as; 1) partial response (PR): At least 2 PR or better (PR followed by PR or PR followed by CR) at least 4 weeks apart and not qualifying for a complete response (CR), 2) stable disease (SD): At least 1 SD assessment (or better) ≥ 43 days (assuming an 8-week scan interval with a 14-day visit window) after start of study treatment and not qualifying for CR or PR, 4) progressive disease (PD): Documentation of PD after start of study treatment (and not qualifying for CR, PR, or SD), 5) non-evaluable (NE): All other cases.
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=6 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Best Overall Response (BOR)
PR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
SD
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
PD
|
3 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
|
Best Overall Response (BOR)
NE
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study termination, approximately 3.5 yearsPopulation: This is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
Phase 1: The best shrinkage value for the target lesion from baseline
Outcome measures
| Measure |
PRS-344/S095012 80mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=9 Participants
PRS-344/S095012 and Obinutuzumab
|
PRS-344/S095012 12mg
n=4 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=8 Participants
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=10 Participants
PRS-344/S095012 Monotherapy
|
|---|---|---|---|---|---|
|
Best Tumor Shrinkage From Baseline
|
78.3 mm
Standard Deviation 86.05
|
94.1 mm
Standard Deviation 68.68
|
104.5 mm
Standard Deviation 150.05
|
102.5 mm
Standard Deviation 67.24
|
115.3 mm
Standard Deviation 107.91
|
Adverse Events
PRS-344/S095012 12mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
PRS-344/S095012 36mg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 5 deaths
PRS-344/S095012 60mg
Serious events: 12 serious events
Other events: 14 other events
Deaths: 14 deaths
PRS-344/S095012 80mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
PRS-344/S095012 36mg and Obinutuzumab
Serious events: 11 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
PRS-344/S095012 12mg
n=4 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 80mg
n=6 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 participants at risk
PRS-344/S095012 and Obinutuzumab
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
25.0%
3/12 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
28.6%
4/14 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
35.7%
5/14 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
4/12 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
Other adverse events
| Measure |
PRS-344/S095012 12mg
n=4 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg
n=9 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 60mg
n=14 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 80mg
n=6 participants at risk
PRS-344/S095012 Monotherapy
|
PRS-344/S095012 36mg and Obinutuzumab
n=12 participants at risk
PRS-344/S095012 and Obinutuzumab
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
28.6%
4/14 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Cardiac disorders
Pericardial effusion
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
2/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
25.0%
3/12 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
66.7%
4/6 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
41.7%
5/12 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Oral discharge
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
3/9 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Asthenia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Device related thrombosis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
3/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
64.3%
9/14 • Number of events 9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
50.0%
3/6 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
58.3%
7/12 • Number of events 7 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Malaise
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
3/9 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
50.0%
7/14 • Number of events 9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
25.0%
3/12 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Oral infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
44.4%
4/9 • Number of events 12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
2/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Injury, poisoning and procedural complications
Tooth injury
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
28.6%
4/14 • Number of events 7 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
3/9 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
28.6%
4/14 • Number of events 7 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood creatine phosphokinase increased
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
C-reactive protein increased
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 5 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Platelet count increased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
28.6%
4/14 • Number of events 4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
41.7%
5/12 • Number of events 6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
2/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
2/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
22.2%
2/9 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
21.4%
3/14 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
33.3%
3/9 • Number of events 3 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
50.0%
2/4 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
14.3%
2/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
2/12 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
8.3%
1/12 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 2 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
16.7%
1/6 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
11.1%
1/9 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/14 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/9 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
7.1%
1/14 • Number of events 1 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/6 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
0.00%
0/12 • Through study termination, approximately 3.5 years
All-Cause Mortality is assessed for all randomized participants, regardless of whether the IMP (PRS-344/S095012) was actually taken or not. Serious Adverse Events and Other (Not Including Serious) Adverse Events assessed is based on the treated set which was defined as all participants who received at least one dose of IMP (PRS-344/S095012).
|
Additional Information
Institut de Recherches Internationales Servier (I.R.I.S.)
Clinical Studies Department
Phone: +33 1 55 72 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place