Trial Outcomes & Findings for PF-06671008 Dose Escalation Study in Advanced Solid Tumors (NCT NCT02659631)
NCT ID: NCT02659631
Last Updated: 2020-05-06
Results Overview
DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 x 10\^9/L with a single temperature of \>38.3°C, or 101°F, or a sustained temperature of \>=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline through Day 21 (Cycle 1)
Results posted on
2020-05-06
Participant Flow
Twenty-eight (28) participants were enrolled and 27 participants received study drug. One participant discontinued before receiving treatment.
Participant milestones
| Measure |
PF-06671008 1.5 ng/kg IV
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
3
|
2
|
5
|
5
|
4
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
2
|
5
|
3
|
1
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
PF-06671008 1.5 ng/kg IV
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 nanogram/kilogram (ng/kg). PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal prior to treatment
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant refused further follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death (follow-up phase)
|
1
|
2
|
1
|
1
|
3
|
2
|
0
|
3
|
1
|
0
|
|
Overall Study
Death (treatment phase)
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
PF-06671008 Dose Escalation Study in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
18 - 44 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Age, Customized
45 - 64 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 21 (Cycle 1)Population: All enrolled participants who received at least one dose of study intervention.
DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 x 10\^9/L with a single temperature of \>38.3°C, or 101°F, or a sustained temperature of \>=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 monthsPopulation: This study was terminated early and Part 2 was not initiated. Data for this outcome measure was not collected.
Number of participants with OR based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Maximum serum concentration (Cmax) of PF-06671008 was observed directly from data. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of PF-06671008
Cycle 1 Day 1
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
0.1926 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
1.108 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
2.008 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
2.387 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
4.049 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
|
Maximum Serum Concentration (Cmax) of PF-06671008
Cycle 2 Day 1
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
0.2470 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
0.8471 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
2.014 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 7
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Time for Maximum serum concentration (Tmax) of PF-06671008 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
Cycle 1 Day 1
|
—
|
2.02 hours
Interval 2.02 to 2.02
|
4.05 hours
Interval 2.0 to 4.08
|
2.29 hours
Interval 1.92 to 2.65
|
2.07 hours
Interval 2.0 to 4.1
|
2.33 hours
Interval 2.0 to 3.98
|
2.17 hours
Interval 2.05 to 3.63
|
2.05 hours
Interval 2.05 to 3.0
|
50.5 hours
Interval 8.12 to 92.9
|
1.92 hours
Interval 1.92 to 1.92
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008
Cycle 2 Day 1
|
—
|
2.12 hours
Interval 2.12 to 2.12
|
3.98 hours
Interval 2.0 to 4.22
|
3.90 hours
Interval 3.9 to 3.9
|
4.00 hours
Interval 2.17 to 4.28
|
2.09 hours
Interval 1.92 to 2.17
|
2.14 hours
Interval 2.1 to 2.17
|
—
|
24.6 hours
Interval 23.4 to 25.7
|
1.98 hours
Interval 1.98 to 1.98
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Terminal elimination half-life (t1/2) of PF-06671008 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. Arithmetic mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of PF-06671008
Cycle 1 Day 1
|
—
|
—
|
—
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
31.77 hours
Standard Deviation 7.6055
|
35.30 hours
Standard Deviation 5.4065
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
—
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
|
Terminal Elimination Half-life (t1/2) of PF-06671008
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
NA hours
Standard Deviation NA
Summary statistics are not presented as arithmetic means were not calculated if fewer than 3 participants had reportable values.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Tau refers to the dosing interval, which was 1 week. Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008
Cycle 1 Day 1
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
5.252 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 25
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
42.75 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 35
|
87.31 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 29
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008
Cycle 2 Day 1
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
10.31 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 43
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
79.17 nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation 36
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA nanogram.hour/milliliter (ng.hr/mL)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
AUCinf was calculated as AUClast +(Clast\*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008
Cycle 1 Day 1
|
—
|
—
|
—
|
NA ng.hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
47.09 ng.hr/mL
Geometric Coefficient of Variation 41
|
90.35 ng.hr/mL
Geometric Coefficient of Variation 19
|
NA ng.hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA ng.hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
NA ng.hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Systemic Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=1 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) of PF-06671008
Cycle 2 Day 1
|
—
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
1.954 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 40
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
1.827 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 77
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
|
Systemic Clearance (CL) of PF-06671008
Cycle 1 Day 1
|
—
|
—
|
—
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
2.191 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 47
|
2.236 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 20
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
NA milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
SECONDARY outcome
Timeframe: C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dosePopulation: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment.
Apparent Clearance (CL/F) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arm. Geometric mean was not calculated if fewer than 3 participants had reportable parameter values.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06671008
Cycle 2 Day 1
|
NA mL/hr/kg
Geometric Coefficient of Variation NA
Summary statistics are not presented as geometric means were not calculated if fewer than 3 participants had reportable values.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression, unacceptable toxicity, or up to 24 monthsPopulation: All randomized participants who received at least 1 dose of study intervention, had measurable disease baseline assessment and at least 1 post baseline assessment or disease progression or death before the first tumor assessment. No participants met the criteria of OR.
Number of participants with OR based on assessment of CR or PR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With OR - Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 monthsPopulation: This study was terminated early and Part 2 was not initiated. Data for this outcome measure were not collected.
The period from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and every 6 weeks for the first 6 months, then every 12 weeks until disease progression or unacceptable toxicity, or up to 24 monthsPopulation: This study was terminated early and Part 2 was not initiated. Data for this outcome measure were not collected.
The period from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: C1D1 0 hrs, D15 0 hrs, and C2D1 0 hrs, and D1 0 hrs post additional dosings, up to 24 monthsPopulation: All enrolled participants who received at least one dose of study intervention and had at least one post dose ADA sample analyzed.
ADA against PF-06671008 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.18 was considered positive.
Outcome measures
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 Participants
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 Participants
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 Participants
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
NAb
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
NA Participants
NAb samples were not analyzed for this study.
|
|
Number of Participants With Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06671008
ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
PF-06671008 1.5 ng/kg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
PF-06671008 7.5 ng/kg IV
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
PF-06671008 20 ng/kg IV
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
PF-06671008 50 ng/kg IV
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
PF-06671008 100 ng/kg IV
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
PF-06671008 200 ng/kg IV
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
PF-06671008 300 ng/kg IV
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
PF-06671008 400 ng/kg IV
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
PF-06671008 200 ng/kg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 participants at risk
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 participants at risk
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
2/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
4/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
80.0%
4/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
PF-06671008 1.5 ng/kg IV
n=1 participants at risk
PF-06671008 was administered as a weekly intravenous (IV) infusion in 21-day cycles at 1.5 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 7.5 ng/kg IV
n=2 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 7.5 ng/kg. PF-06671008 was administered for up to 3 cycles in this cohort.
|
PF-06671008 20 ng/kg IV
n=3 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 20 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 50 ng/kg IV
n=2 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 50 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 100 ng/kg IV
n=4 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 100 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 200 ng/kg IV
n=5 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 16 cycles in this cohort.
|
PF-06671008 300 ng/kg IV
n=4 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 300 ng/kg. PF-06671008 was administered for up to 4 cycles in this cohort.
|
PF-06671008 400 ng/kg IV
n=3 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at 400 ng/kg. PF-06671008 was administered for up to 2 cycles in this cohort.
|
PF-06671008 200 ng/kg SC
n=2 participants at risk
PF-06671008 was administered as a weekly subcutaneous (SC) injection in 21-day cycles at 200 ng/kg. PF-06671008 was administered for up to 5 cycles in this cohort.
|
PF-06671008 200 ng/kg Prime and 300 ng/kg Maintenance IV
n=1 participants at risk
PF-06671008 was administered as a weekly IV infusion in 21-day cycles at a priming dose of 200 ng/kg on Cycle 1 Day 1 (C1D1) and 300 ng/kg for all subsequent dosing. PF-06671008 was administered for up to 4 cycles in this cohort.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site erythema
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Nodule
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
1/1 • For all Adverse Events: Start of treatment to and including 28 days after the last dose. For All-Cause Mortality: Start of treatment to and including 28 days after the last dose + follow-up period (up to 2 years)
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER