Trial Outcomes & Findings for Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (NCT NCT03296696)
NCT ID: NCT03296696
Last Updated: 2024-10-29
Results Overview
A DLT was any of the following occurring and regarded by the investigator as related to AMG 596. Hematological DLTs: absolute neutrophil count (ANC) \<0.5×10\^9/L for ≥7 days, febrile neutropenia with ANC\<0.5×10\^9/L and fever ≥38.5°C, platelets\<50×10\^9/L\>7 days or clinically significant bleeding. Non-hematological DLTs: any grade 4 non-hematological toxicity, any grade ≥3 non-hematological toxicity if nausea and vomiting, grade 3 non-hematologic toxicity lasting \>3 days despite treatment, grade 3 fatigue wasn't classified as DLT, grade 3 acute kidney injury, grade 3 seizure, ataxia, encephalopathy, other grade 3 neurologic-related adverse events lasting \>3 days despite treatment, neurologic-related adverse event leading to treatment interruption needing\>1 week to resolve to grade≤1, any grade 3 endocrinopathy that can't be controlled by hormonal replacement. Toxicity grading was graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-10-29
Participant Flow
Participants were enrolled from April 18, 2018 and last participant visit was August 28, 2021. Participants enrolled at 9 centers in United States, Australia, France, Germany, Netherlands, and Spain.
Of the planned 200 participants, 30 were enrolled. Of the 30 participants enrolled, 29 received investigational product. Due to early termination, participants were only enrolled into dose escalation AMG 596 monotherapy arms.
Participant milestones
| Measure |
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
3
|
4
|
4
|
4
|
4
|
5
|
1
|
1
|
|
Overall Study
Received Investigational Product
|
1
|
3
|
3
|
4
|
3
|
4
|
4
|
5
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
4
|
4
|
4
|
3
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Started Other Antitumor Therapy
|
1
|
2
|
1
|
2
|
1
|
1
|
2
|
3
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
2
|
2
|
3
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
Baseline characteristics by cohort
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=4 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
51.0 Years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
56.7 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
58.0 Years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
51.5 Years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
55.0 Years
STANDARD_DEVIATION 4.9 • n=8 Participants
|
51.5 Years
STANDARD_DEVIATION 12.4 • n=8 Participants
|
53.0 Years
STANDARD_DEVIATION 5.5 • n=24 Participants
|
44.0 Years
STANDARD_DEVIATION NA • n=42 Participants
|
49.0 Years
STANDARD_DEVIATION NA • n=42 Participants
|
54.1 Years
STANDARD_DEVIATION 7.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
24 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The DLT Evaluable Analysis Set included all participants in the 7-day on/7-day off dosing groups who completed 100% of planned doses and all participants in the 28-day on/14-day off dosing groups who completed 90% of planned doses.
A DLT was any of the following occurring and regarded by the investigator as related to AMG 596. Hematological DLTs: absolute neutrophil count (ANC) \<0.5×10\^9/L for ≥7 days, febrile neutropenia with ANC\<0.5×10\^9/L and fever ≥38.5°C, platelets\<50×10\^9/L\>7 days or clinically significant bleeding. Non-hematological DLTs: any grade 4 non-hematological toxicity, any grade ≥3 non-hematological toxicity if nausea and vomiting, grade 3 non-hematologic toxicity lasting \>3 days despite treatment, grade 3 fatigue wasn't classified as DLT, grade 3 acute kidney injury, grade 3 seizure, ataxia, encephalopathy, other grade 3 neurologic-related adverse events lasting \>3 days despite treatment, neurologic-related adverse event leading to treatment interruption needing\>1 week to resolve to grade≤1, any grade 3 endocrinopathy that can't be controlled by hormonal replacement. Toxicity grading was graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was any AE that begun or worsened after the initial dose of investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that begun or worsened after the initial dose of investigational product were recorded as TEAEs.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
A treatment-related AE was defined as any untoward medical occurrence in a clinical trial participant that was considered related to the investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that were considered related to the investigational product were recorded as treatment-related AEs.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs)
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion endPopulation: The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Steady-state Concentration (Css) of Serum AMG 596
Cycle 1
|
0.733 ng/mL
Interval 0.733 to 0.733
|
1.90 ng/mL
Interval 1.87 to 1.93
|
3.38 ng/mL
Interval 3.28 to 3.47
|
9.53 ng/mL
Interval 2.98 to 14.0
|
26.7 ng/mL
Interval 22.4 to 29.8
|
67.1 ng/mL
Interval 45.9 to 89.0
|
106 ng/mL
Interval 72.5 to 136.0
|
180 ng/mL
Interval 103.0 to 222.0
|
610 ng/mL
Interval 610.0 to 610.0
|
19.4 ng/mL
Interval 19.4 to 19.4
|
|
Average Steady-state Concentration (Css) of Serum AMG 596
Cycle 2
|
0.548 ng/mL
Interval 0.548 to 0.548
|
1.48 ng/mL
Interval 0.872 to 2.51
|
3.37 ng/mL
Interval 2.81 to 3.93
|
11.4 ng/mL
Interval 6.91 to 13.7
|
36.2 ng/mL
Interval 25.6 to 46.9
|
74.3 ng/mL
Interval 25.0 to 144.0
|
115 ng/mL
Interval 60.1 to 157.0
|
194 ng/mL
Interval 148.0 to 254.0
|
807 ng/mL
Interval 807.0 to 807.0
|
—
|
SECONDARY outcome
Timeframe: Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion endPopulation: The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint. 0 participants had evaluable data for the determination of AUC, therefore 0 participants were analyzed for this endpoint.
There were insufficient evaluable samples collected for the determination of AUC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion endPopulation: The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Clearance (CL) is calculated based on dose and AUC.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=2 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=3 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=4 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance for Serum AMG 596
Cycle 1
|
0.0324 mcg/day/(hr*ng/mL)
Interval 0.0324 to 0.0324
|
0.0116 mcg/day/(hr*ng/mL)
Interval 0.0102 to 0.013
|
0.0172 mcg/day/(hr*ng/mL)
Interval 0.0122 to 0.02
|
0.0207 mcg/day/(hr*ng/mL)
Interval 0.0161 to 0.0294
|
0.0272 mcg/day/(hr*ng/mL)
Interval 0.0244 to 0.0309
|
0.0237 mcg/day/(hr*ng/mL)
Interval 0.0188 to 0.0322
|
0.0218 mcg/day/(hr*ng/mL)
Interval 0.0171 to 0.0308
|
0.0291 mcg/day/(hr*ng/mL)
Interval 0.0197 to 0.0464
|
0.0146 mcg/day/(hr*ng/mL)
Interval 0.0146 to 0.0146
|
0.158 mcg/day/(hr*ng/mL)
Interval 0.158 to 0.158
|
|
Clearance for Serum AMG 596
Cycle 2
|
0.0469 mcg/day/(hr*ng/mL)
Interval 0.0469 to 0.0469
|
0.0175 mcg/day/(hr*ng/mL)
Interval 0.0091 to 0.0259
|
0.0232 mcg/day/(hr*ng/mL)
Interval 0.0232 to 0.0232
|
0.0228 mcg/day/(hr*ng/mL)
Interval 0.0163 to 0.0309
|
—
|
0.0256 mcg/day/(hr*ng/mL)
Interval 0.0256 to 0.0256
|
0.0161 mcg/day/(hr*ng/mL)
Interval 0.0147 to 0.0175
|
0.0245 mcg/day/(hr*ng/mL)
Interval 0.0245 to 0.0245
|
0.0113 mcg/day/(hr*ng/mL)
Interval 0.0113 to 0.0113
|
—
|
SECONDARY outcome
Timeframe: Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion endPopulation: The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
The formula for volume of distribution is dose/concentration. For this study, the dose is measured in mcg/day and concentration is measure as ng/mL resulting in units of mcg/day/(ng/mL) for volume of distribution.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=2 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=3 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=4 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady-State for Serum AMG 596
Cycle 1
|
0.269 mcg/day/(ng/mL)
Interval 0.269 to 0.269
|
0.0961 mcg/day/(ng/mL)
Interval 0.0637 to 0.128
|
0.173 mcg/day/(ng/mL)
Interval 0.125 to 0.213
|
0.247 mcg/day/(ng/mL)
Interval 0.198 to 0.325
|
0.200 mcg/day/(ng/mL)
Interval 0.155 to 0.28
|
0.212 mcg/day/(ng/mL)
Interval 0.109 to 0.278
|
0.205 mcg/day/(ng/mL)
Interval 0.155 to 0.268
|
0.269 mcg/day/(ng/mL)
Interval 0.185 to 0.387
|
0.166 mcg/day/(ng/mL)
Interval 0.166 to 0.166
|
1.61 mcg/day/(ng/mL)
Interval 1.61 to 1.61
|
|
Apparent Volume of Distribution at Steady-State for Serum AMG 596
Cycle 2
|
0.289 mcg/day/(ng/mL)
Interval 0.289 to 0.289
|
0.162 mcg/day/(ng/mL)
Interval 0.0929 to 0.232
|
0.246 mcg/day/(ng/mL)
Interval 0.246 to 0.246
|
0.242 mcg/day/(ng/mL)
Interval 0.158 to 0.354
|
—
|
0.223 mcg/day/(ng/mL)
Interval 0.223 to 0.223
|
0.140 mcg/day/(ng/mL)
Interval 0.0836 to 0.196
|
0.235 mcg/day/(ng/mL)
Interval 0.235 to 0.235
|
0.115 mcg/day/(ng/mL)
Interval 0.115 to 0.115
|
—
|
SECONDARY outcome
Timeframe: Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion endPopulation: The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=2 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=3 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=4 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) Associated With Lambda z (λz) for Serum AMG 596
Cycle 1
|
5.75 Hours
Interval 5.75 to 5.75
|
5.59 Hours
Interval 4.34 to 6.84
|
6.98 Hours
Interval 6.42 to 7.39
|
8.44 Hours
Interval 7.66 to 9.1
|
5.02 Hours
Interval 4.37 to 6.29
|
6.16 Hours
Interval 3.96 to 7.49
|
6.67 Hours
Interval 5.31 to 8.51
|
6.54 Hours
Interval 5.77 to 7.23
|
7.90 Hours
Interval 7.9 to 7.9
|
7.04 Hours
Interval 7.04 to 7.04
|
|
Terminal Half-life (t1/2) Associated With Lambda z (λz) for Serum AMG 596
Cycle 2
|
4.27 Hours
Interval 4.27 to 4.27
|
6.64 Hours
Interval 6.21 to 7.07
|
7.33 Hours
Interval 7.33 to 7.33
|
7.23 Hours
Interval 6.72 to 7.94
|
—
|
6.05 Hours
Interval 6.05 to 6.05
|
5.87 Hours
Interval 3.95 to 7.79
|
6.64 Hours
Interval 6.64 to 6.64
|
7.05 Hours
Interval 7.05 to 7.05
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 MonthsPopulation: The RANO Evaluable Analysis set included all participants that were enrolled and received at least one administration of AMG 596 and who had at least one measurable lesion identified by the Principal Investigator at baseline.
Objective response was defined as the number of participants with complete response (CR) or partial response (PR) per modified RANO criteria. CR per modified RANO: disappearance of all enhancing disease, no new lesions, stable or improved T2-weighted fluid-attenuated inversion recovery (T2/FLAIR), no more than physiological steroids, clinically stable or improved, disappearance confirmed with follow-up scans after ≥4 weeks. PR per modified RANO: ≥50% decrease in the sum of perpendicular diameters of enhancing disease from baseline, stable or improved T2/FLAIR, stable or decreased steroid dose, clinically stable or improved, decrease confirmed with follow up scan after ≥ 4 weeks.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=3 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Objective Response (OR) Per Modified Response Assessment in Neuro-Oncology Criteria (RANO) Criteria With AMG 596 Monotherapy
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596. Only participants with OR were used for this analysis.
Time to response was calculated as the number of months from the date of first administration of AMG 596 to the date of confirmation of first objective response per magnetic resonance imaging (MRI) scan. If a participant did not respond, time to response was censored at the date of the last evaluable response assessment.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=1 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response With AMG 596 Monotherapy
|
—
|
7.0 Months
Only 1 participant with evaluable data, therefore lower and upper confidence intervals could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596. Only participants with OR were used for this analysis.
Response duration was analysed as the number of months between the first tumor response assessment of an OR (PR or CR) which is subsequently confirmed to the time of the first tumor response assessment of progressive disease or death if due to disease progression.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=1 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Response Duration With AMG 596 Monotherapy
|
—
|
27.9 Months
Only 1 participant with evaluable data, therefore lower and upper confidence intervals could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 MonthsPopulation: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596
The TTP was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor. Participants who did not have progression were censored at the last radiological non-missing evaluable tumor assessment date.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) With AMG 596 Monotherapy
|
2.1 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
1.9 Months
Interval 0.7 to
Values are not evaluable as the upper limit was not reached.
|
1.9 Months
Interval 1.2 to
Values are not evaluable as the upper limit was not reached.
|
2.6 Months
Interval 2.4 to
Values are not evaluable as the upper limit was not reached.
|
1.2 Months
Interval 0.1 to
Values are not evaluable as the upper limit was not reached.
|
1.7 Months
Interval 1.0 to
Values are not evaluable as the upper limit was not reached.
|
2.4 Months
Interval 1.2 to
Values are not evaluable as the upper limit was not reached.
|
7.0 Months
Interval 1.3 to
Values are not evaluable as the upper limit was not reached.
|
5.3 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
2.6 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
The PFS was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor, or date of death, whichever was earlier.
Outcome measures
| Measure |
AMG 596 Monotherapy 4.5 mcg
n=1 Participants
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 15 mcg
n=3 Participants
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 45 mcg
n=3 Participants
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG 596 Monotherapy 150 mcg
n=4 Participants
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 500 mcg
n=3 Participants
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1000 mcg
n=4 Participants
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500 mcg
n=4 Participants
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 3000 mcg
n=5 Participants
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 6000 mcg
n=1 Participants
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
|
AMG596 Monotherapy 1500/15 mcg
n=1 Participants
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) With AMG 596 Monotherapy
|
2.1 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
1.9 Months
Interval 0.7 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
1.9 Months
Interval 1.2 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
2.6 Months
Interval 2.4 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
1.2 Months
Interval 0.1 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
1.7 Months
Interval 1.0 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
2.4 Months
Interval 1.2 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
5.8 Months
Interval 1.3 to
Upper confidence limit could not be calculated due to the low number of events reported.
|
5.3 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
2.6 Months
Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
|
Adverse Events
AMG596 4.5 mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AMG596 15 mcg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
AMG596 45 mcg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
AMG596 150 mcg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
AMG596 500 mcg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
AMG596 1000 mcg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
AMG596 1500 mcg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
AMG596 3000 mcg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
AMG596 6000 mcg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
AMG596 1500/15 mcg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG596 4.5 mcg
n=1 participants at risk
AMG596 4.5 mcg/day 7 Day cIV
|
AMG596 15 mcg
n=3 participants at risk
AMG596 15 mcg/day 7/28 Day cIV
|
AMG596 45 mcg
n=3 participants at risk
AMG596 45 mcg/day 28 Day cIV
|
AMG596 150 mcg
n=4 participants at risk
AMG596 150 mcg/day 28 Day cIV
|
AMG596 500 mcg
n=3 participants at risk
AMG596 500 mcg/day 28 Day cIV
|
AMG596 1000 mcg
n=4 participants at risk
AMG596 1000 mcg/day 28 Day cIV
|
AMG596 1500 mcg
n=4 participants at risk
AMG596 1500 mcg/day 28 Day cIV
|
AMG596 3000 mcg
n=5 participants at risk
AMG596 3000 mcg/day 28 Day cIV
|
AMG596 6000 mcg
n=1 participants at risk
AMG596 6000 mcg/day 28 Day cIV
|
AMG596 1500/15 mcg
n=1 participants at risk
AMG596 1500/15 mcg/day 28 Day cIV
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Hyperthermia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Vascular access site infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
Other adverse events
| Measure |
AMG596 4.5 mcg
n=1 participants at risk
AMG596 4.5 mcg/day 7 Day cIV
|
AMG596 15 mcg
n=3 participants at risk
AMG596 15 mcg/day 7/28 Day cIV
|
AMG596 45 mcg
n=3 participants at risk
AMG596 45 mcg/day 28 Day cIV
|
AMG596 150 mcg
n=4 participants at risk
AMG596 150 mcg/day 28 Day cIV
|
AMG596 500 mcg
n=3 participants at risk
AMG596 500 mcg/day 28 Day cIV
|
AMG596 1000 mcg
n=4 participants at risk
AMG596 1000 mcg/day 28 Day cIV
|
AMG596 1500 mcg
n=4 participants at risk
AMG596 1500 mcg/day 28 Day cIV
|
AMG596 3000 mcg
n=5 participants at risk
AMG596 3000 mcg/day 28 Day cIV
|
AMG596 6000 mcg
n=1 participants at risk
AMG596 6000 mcg/day 28 Day cIV
|
AMG596 1500/15 mcg
n=1 participants at risk
AMG596 1500/15 mcg/day 28 Day cIV
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
75.0%
3/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
80.0%
4/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Hypokinesia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Language disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Mucosal inflammation
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Eye disorders
Chalazion
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Eye disorders
Eye disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Asthenia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Chills
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Device related thrombosis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
3/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
66.7%
2/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
60.0%
3/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Malaise
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Oedema
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Nasopharyngitis
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Interleukin level increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Lymphocyte count abnormal
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Investigations
White blood cell count increased
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
40.0%
2/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Product Issues
Device malfunction
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Confusional state
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
50.0%
2/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
100.0%
1/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
33.3%
1/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
25.0%
1/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/3 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/4 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
20.0%
1/5 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
0.00%
0/1 • Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
|
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