Trial Outcomes & Findings for Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104) (NCT NCT04218851)
NCT ID: NCT04218851
Last Updated: 2025-01-14
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 14 days after treatment (up to Day 102)
Results posted on
2025-01-14
Participant Flow
Male or female participants with a diagnosis of possible, probable, or proven invasive aspergillosis (IA) aged 2 to \<18 years were enrolled in this study.
Participant milestones
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Baseline characteristics by cohort
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.9 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
11.1 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after treatment (up to Day 102)Population: All enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs)
|
14.3 Percentage of participants
95% Confidence Interval 1.8 • Interval 1.8 to 42.8
|
29.4 Percentage of participants
95% Confidence Interval 10.3 • Interval 10.3 to 56.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 6Population: Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data.
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6
Success, Complete Response
|
42.9 Percentage of participants
|
17.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6
Success, Partial Response
|
21.4 Percentage of participants
|
52.9 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data.
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12
Success, Complete Response
|
57.1 Percentage of participants
|
41.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12
Success, Partial Response
|
21.4 Percentage of participants
|
35.3 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days post-treatment (up to Day 116)Population: Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; have baseline data for those analyses that require baseline data; and who have achieved a favorable global clinical response at the end of study treatment.
In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=12 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts.
Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing).
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=16 Cavg value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=25 Cavg value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=41 Cavg value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Average Plasma Concentration (Cavg) of POS by Age Cohorts
|
2590 ng/mL
Geometric Coefficient of Variation 50.8
|
2770 ng/mL
Geometric Coefficient of Variation 55.4
|
2700 ng/mL
Geometric Coefficient of Variation 53.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts.
Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing).
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=16 Cmin value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=25 Cmin value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=41 Cmin value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) of POS by Age Cohorts
|
1610 ng/mL
Geometric Coefficient of Variation 66.3
|
1920 ng/mL
Geometric Coefficient of Variation 63.9
|
1790 ng/mL
Geometric Coefficient of Variation 64.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts.
Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing).
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=16 Cmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=25 Cmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=41 Cmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of POS by Age Cohorts
|
3620 ng/mL
Geometric Coefficient of Variation 48.5
|
3610 ng/mL
Geometric Coefficient of Variation 53.7
|
3610 ng/mL
Geometric Coefficient of Variation 51.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts.
Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing).
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=16 AUCtau value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=25 AUCtau value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=41 AUCtau value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts
|
62200 ng*h/mL
Geometric Coefficient of Variation 50.8
|
66400 ng*h/mL
Geometric Coefficient of Variation 55.4
|
64700 ng*h/mL
Geometric Coefficient of Variation 53.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts.
Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing).
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=16 Tmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=25 Tmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=41 Tmax value
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of POS by Age Cohorts
|
1.68 hr.
Interval 1.25 to 7.1
|
1.63 hr.
Interval 1.3 to 7.4
|
1.63 hr.
Interval 1.25 to 7.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation.
Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=6 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=1 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
n=2 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Average Plasma Concentration (Cavg) of POS by Formulation
|
2900 ng/mL
Geometric Coefficient of Variation 51.6
|
2070 ng/mL
Geometric Coefficient of Variation 38.0
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
2860 ng/mL
Geometric Coefficient of Variation 45.8
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
2500 ng/mL
Geometric Coefficient of Variation 72.7
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation.
Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=6 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=1 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
n=2 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) of POS by Formulation
|
1680 ng/mL
Geometric Coefficient of Variation 74.8
|
1410 ng/mL
Geometric Coefficient of Variation 44.8
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
1820 ng/mL
Geometric Coefficient of Variation 56.5
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
1910 ng/mL
Geometric Coefficient of Variation 80.5
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation.
Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=6 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=1 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
n=2 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of POS by Formulation
|
4530 ng/mL
Geometric Coefficient of Variation 39.2
|
2510 ng/mL
Geometric Coefficient of Variation 36.3
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
4180 ng/mL
Geometric Coefficient of Variation 38.8
|
NA ng/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
2880 ng/mL
Geometric Coefficient of Variation 69.3
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation.
Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=6 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=1 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
n=2 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation
|
69600 ng*h/mL
Geometric Coefficient of Variation 51.6
|
49700 ng*h/mL
Geometric Coefficient of Variation 38.0
|
NA ng*h/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
68600 ng*h/mL
Geometric Coefficient of Variation 45.8
|
NA ng*h/mL
Geometric Coefficient of Variation NA
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
60100 ng*h/mL
Geometric Coefficient of Variation 72.7
|
SECONDARY outcome
Timeframe: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12Population: All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation.
Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=6 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
n=1 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
n=13 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
n=2 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of POS by Formulation
|
1.50 hr
Interval 1.25 to 1.77
|
7.00 hr
Interval 6.5 to 7.1
|
NA hr
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
1.50 hr
Interval 1.3 to 1.63
|
NA hr
NA = Per protocol, summary statistics were not calculated where N are 2 or less values.
|
7.20 hr
Interval 6.9 to 7.4
|
SECONDARY outcome
Timeframe: First day of PFS treatment (Day 8)Population: Participants who completed the palatability questionnaire. Per protocol participants were pooled into a single treatment group.
Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Good
|
40 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Very good
|
20 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Very bad
|
10 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Neither good nor bad
|
30 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Last day of PFS treatment (Day 85)Population: Participants who completed the palatability questionnaire. Per protocol participants were pooled into a single treatment group.
Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Outcome measures
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=10 Participants
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohorts 1 and 2 (2 -< 18 Years Old)
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): IV Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): PFS Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Very good
|
10 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Good
|
40 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Very bad
|
10 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Neither good nor bad
|
40 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Age Cohort 1 (2 -< 12 Years Old)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 2 deaths
Age Cohort 2 (12 -< 18 Years Old)
Serious events: 8 serious events
Other events: 14 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 participants at risk
On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 participants at risk
On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Administration site extravasation
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Device related sepsis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Gastroenteritis clostridial
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Lymphadenitis bacterial
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Weight decreased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration extramedullary
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
Other adverse events
| Measure |
Age Cohort 1 (2 -< 12 Years Old)
n=14 participants at risk
On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
Age Cohort 2 (12 -< 18 Years Old)
n=17 participants at risk
On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
|
|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Cardiac disorders
Bradycardia
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Cardiac disorders
Sinus bradycardia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Cardiac disorders
Tachycardia
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Congenital, familial and genetic disorders
Aplasia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Eye disorders
Eyelid oedema
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Eye disorders
Oculogyric crisis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • Number of events 7 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Anal fissure
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
23.5%
4/17 • Number of events 5 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
41.2%
7/17 • Number of events 12 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Chills
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Feeling hot
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Hypothermia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Malaise
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Pyrexia
|
21.4%
3/14 • Number of events 14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
35.3%
6/17 • Number of events 6 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Hepatobiliary disorders
Cholestasis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Adenovirus interstitial nephritis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
BK virus infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Cytomegalovirus urinary tract infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Device related infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Infectious disease carrier
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Nail infection
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Paronychia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Urinary tract infection viral
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Viraemia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Infections and infestations
Viruria
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Injury, poisoning and procedural complications
Head injury
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
23.5%
4/17 • Number of events 7 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
23.5%
4/17 • Number of events 7 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
2/14 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Hepatic enzyme increased
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Liver function test increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Platelet count decreased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Investigations
Weight increased
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
23.5%
4/17 • Number of events 6 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
23.5%
4/17 • Number of events 5 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
11.8%
2/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Kidney enlargement
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
2/14 • Number of events 4 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Vascular disorders
Hypertension
|
21.4%
3/14 • Number of events 5 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
29.4%
5/17 • Number of events 5 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
0.00%
0/17 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/14 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER