Trial Outcomes & Findings for Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease (NCT NCT03422627)
NCT ID: NCT03422627
Last Updated: 2023-11-22
Results Overview
A DLT was defined as a: * Non-hematological toxicity ≥grade-4(per common terminology criteria for adverse events \[CTCAE\] v4.03) related to efavaleukin alfa. Non-hematological lab abnormalities without clinical significance weren't considered DLTs. * Hematological toxicity ≥grade 4 related to efavaleukin alfa defined as decreases in peripheral counts (absolute neutrophil count or platelets) persisting longer than 72 hrs, as measured by 2 separate results, that were not related to malignant disease relapse, infection, or other etiologies. * Constitutional events (ie, fever, fatigue) ≥grade 3 that were classified as serious adverse events by the investigator and related to efavaleukin alfa. * Infection is considered an expected complication of chronic graft versus host disease (cGVHD) and its treatment. Only grade 4 or 5 infections considered by the investigator to be related to efavaleukin alfa were reviewed by the dose level review meeting to determine whether it was considered a DLT.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 4 weeks after first dose of study drug administration
Results posted on
2023-11-22
Participant Flow
Participants were enrolled into this study at sites in Belgium, France, Japan, and the United States.
Screening tests and procedures were performed up to 28 days preceding treatment. The study was planned to have a Phase 1b part and a Phase 2 part. The study was cancelled before enrolling participants into the Phase 2 part. Therefore, results presented only include data for the Phase 1b part.
Participant milestones
| Measure |
Cohort 1
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
6
|
5
|
|
Overall Study
Completed up to Week 52 and Opted for Extended Dosing
|
2
|
1
|
2
|
3
|
0
|
|
Overall Study
Completed up to Week 52 and Did Not Opt for Extended Dosing
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol-specified Criteria
|
1
|
1
|
0
|
0
|
2
|
|
Overall Study
Requirement for Alternative Therapy
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
2
|
|
Overall Study
Ineligibility Determined
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
Baseline characteristics by cohort
| Measure |
Cohort 1
n=7 Participants
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 Participants
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 Participants
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 Participants
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 Participants
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
53.5 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after first dose of study drug administrationPopulation: Measured in the DLT analysis set, which included DLT-evaluable participants in the phase 1b portion of the study. To be evaluable for a DLT participants must have received at least 2 doses of efavaleukin alfa or have experienced a DLT within the DLT evaluation period. The DLT evaluation period was defined as 4 weeks after the first dose of the study drug.
A DLT was defined as a: * Non-hematological toxicity ≥grade-4(per common terminology criteria for adverse events \[CTCAE\] v4.03) related to efavaleukin alfa. Non-hematological lab abnormalities without clinical significance weren't considered DLTs. * Hematological toxicity ≥grade 4 related to efavaleukin alfa defined as decreases in peripheral counts (absolute neutrophil count or platelets) persisting longer than 72 hrs, as measured by 2 separate results, that were not related to malignant disease relapse, infection, or other etiologies. * Constitutional events (ie, fever, fatigue) ≥grade 3 that were classified as serious adverse events by the investigator and related to efavaleukin alfa. * Infection is considered an expected complication of chronic graft versus host disease (cGVHD) and its treatment. Only grade 4 or 5 infections considered by the investigator to be related to efavaleukin alfa were reviewed by the dose level review meeting to determine whether it was considered a DLT.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 Participants
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=6 Participants
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 Participants
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=3 Participants
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeksPopulation: Measured in the safety analysis set, which included all participants who received at least 1 dose of efavaleukin alfa.
A treatment-related AE was any untoward medical occurrence in a clinical study participant deemed to have a possibly causal relationship to the study treatment as determined by the investigator.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 Participants
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 Participants
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 Participants
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 Participants
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Treatment-related Adverse Event (AE)
|
5 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeksPopulation: Measured in the safety analysis set, which included all participants who received at least 1 dose of efavaleukin alfa.
A treatment-emergent AE was any untoward medical occurrence in a clinical study participant that occurred after first dose.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 Participants
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 Participants
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 Participants
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 Participants
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent AE
|
6 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeksPopulation: Measured in the safety analysis set, which included all participants who received at least 1 dose of efavaleukin alfa.
A treatment-emergent serious AE was any untoward medical occurrence in a clinical study participant that occurred after first dose that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or another medically important serious event.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 Participants
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 Participants
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 Participants
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 Participants
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Serious AE
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 3
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Cohort 4
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 5
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=7 participants at risk
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 participants at risk
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 participants at risk
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 participants at risk
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 participants at risk
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida sepsis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterococcal sepsis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort 1
n=7 participants at risk
Participants in Cohort 1 received efavaleukin alfa subcutaneously (SC) once every 2 weeks (Q2W) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 1 received dose 2.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 2
n=7 participants at risk
Participants in Cohort 2 received efavaleukin alfa SC once every week (QW) plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 2 received dose 1.
At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 3
n=7 participants at risk
Participants in Cohort 3 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 3 received dose 3. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 4
n=6 participants at risk
Participants in Cohort 4 received efavaleukin alfa SC QW plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 4 received dose 2. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 259 weeks (QW dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
Cohort 5
n=5 participants at risk
Participants in Cohort 5 received efavaleukin alfa SC Q2W plus protocol permitted background therapy for 52 weeks. Four ascending dose levels of efavaleukin alfa were administered between the 5 cohorts as follows. Dose 1 (low dose), dose 2 (low-mid dose), dose 3 (high-mid dose), dose 4 (high dose). Participants in Cohort 5 received dose 4. At the discretion of the sponsor, following discussion and agreement between the principal investigator and medical monitor, participants that responded to efavaleukin alfa were permitted to continue to receive efavaleukin alfa treatment at their current dosing regimen for up to a maximum of 258 weeks (Q2W dose), if they remained eligible for extended dosing. Participants then completed the 6-week safety follow up after their last dose of efavaleukin alfa.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Blepharitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral lichen planus
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Disease progression
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
42.9%
3/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
42.9%
3/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site rash
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Localised oedema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease oral
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Graft versus host disease
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Graft versus host disease in eye
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterococcal sepsis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal disease carrier
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lip infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Mastitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pathogen resistance
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Enterovirus test positive
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
3/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.0%
2/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Cervix oedema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal enanthema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
2/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
42.9%
3/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.0%
1/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
14.3%
1/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/5 • Mortality: from enrollment until the end of study; median (min, max) duration was 38.44 (3.56, 140.09) weeks. Serious and non-serious adverse events: from Day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER