Trial Outcomes & Findings for Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects (NCT NCT04321252)
NCT ID: NCT04321252
Last Updated: 2021-12-13
Results Overview
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
From study treatment start date till 30 days safety follow-up, assessed for up to 4 months
Results posted on
2021-12-13
Participant Flow
This study was conducted in one center in Belgium.
Participant milestones
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
9
|
6
|
6
|
6
|
|
Overall Study
PK Analysis Set
|
6
|
6
|
6
|
6
|
6
|
0
|
6
|
6
|
0
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
n=9 Participants
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
n=6 Participants
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
n=6 Participants
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
n=6 Participants
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
57 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
16 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
41 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
57 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
57 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: From study treatment start date till 30 days safety follow-up, assessed for up to 4 monthsPopulation: Safety Analysis Set
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
n=30 Participants
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
n=9 Participants
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
n=6 Participants
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
n=6 Participants
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
n=12 Participants
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
n=6 Participants
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths
Adverse Events (AEs)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths
Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
|
412 ng/mL
Standard Deviation 101
|
1510 ng/mL
Standard Deviation 1000
|
2910 ng/mL
Standard Deviation 1340
|
5930 ng/mL
Standard Deviation 1190
|
6590 ng/mL
Standard Deviation 1290
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
|
0.167 Hour (hr)
Interval 0.0167 to 0.167
|
0.0333 Hour (hr)
Interval 0.0333 to 0.217
|
0.333 Hour (hr)
Interval 0.183 to 0.55
|
0.167 Hour (hr)
Interval 0.167 to 0.183
|
0.167 Hour (hr)
Interval 0.167 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
2690 h*ng/mL
Standard Deviation 977
|
9540 h*ng/mL
Standard Deviation 1640
|
25400 h*ng/mL
Standard Deviation 1770
|
53700 h*ng/mL
Standard Deviation 20900
|
60800 h*ng/mL
Standard Deviation 11600
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUCinf was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
2770 h*ng/mL
Standard Deviation 990
|
9750 h*ng/mL
Standard Deviation 1730
|
25600 h*ng/mL
Standard Deviation 1730
|
57400 h*ng/mL
Standard Deviation 22100
|
62000 h*ng/mL
Standard Deviation 11500
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)
|
1450 h*ng/mL
Standard Deviation 330
|
4540 h*ng/mL
Standard Deviation 673
|
13500 h*ng/mL
Standard Deviation 2230
|
23200 h*ng/mL
Standard Deviation 7920
|
26200 h*ng/mL
Standard Deviation 3600
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
|
27.7 Hour (hr)
Standard Deviation 8.89
|
30.5 Hour (hr)
Standard Deviation 6.79
|
21.9 Hour (hr)
Standard Deviation 6.76
|
38.9 Hour (hr)
Standard Deviation 12.8
|
29.4 Hour (hr)
Standard Deviation 5.39
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
|
4330 Milliliter/hour (mL/h)
Standard Deviation 1890
|
3150 Milliliter/hour (mL/h)
Standard Deviation 507
|
2940 Milliliter/hour (mL/h)
Standard Deviation 192
|
2430 Milliliter/hour (mL/h)
Standard Deviation 1120
|
3500 Milliliter/hour (mL/h)
Standard Deviation 700
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 Participants
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 Participants
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 Participants
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
|
154000 Milliliter (mL)
Standard Deviation 20400
|
138000 Milliliter (mL)
Standard Deviation 34000
|
92900 Milliliter (mL)
Standard Deviation 29600
|
124000 Milliliter (mL)
Standard Deviation 32700
|
151000 Milliliter (mL)
Standard Deviation 50400
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
Day 1
|
3920 ng/mL
Standard Deviation 999
|
4530 ng/mL
Standard Deviation 705
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
Day 5
|
4630 ng/mL
Standard Deviation 2670
|
5540 ng/mL
Standard Deviation 2090
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Day 1
|
0.100 Hour (hr)
Interval 0.0333 to 0.5
|
0.167 Hour (hr)
Interval 0.167 to 0.183
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Day 5
|
0.0333 Hour (hr)
Interval 0.0333 to 0.167
|
0.167 Hour (hr)
Interval 0.167 to 0.167
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
58500 h*ng/mL
Standard Deviation 23000
|
121000 h*ng/mL
Standard Deviation 56100
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)
Day 1
|
13200 h*ng/mL
Standard Deviation 1770
|
16500 h*ng/mL
Standard Deviation 2290
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)
Day 5
|
20000 h*ng/mL
Standard Deviation 4890
|
40600 h*ng/mL
Standard Deviation 11400
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Day 1
|
25.0 Hour (hr)
Standard Deviation 8.16
|
18.1 Hour (hr)
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Day 5
|
35.5 Hour (hr)
Standard Deviation 8.58
|
31.9 Hour (hr)
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
|
3140 Milliliter/hour (mL/h)
Standard Deviation 717
|
3160 Milliliter/hour (mL/h)
Standard Deviation 907
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)Population: PK analysis set. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Outcome measures
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 Participants
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 Participants
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
|
175000 Milliliter (mL)
Standard Deviation 14700
|
173000 Milliliter (mL)
Standard Deviation 29700
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Pooled KAE609
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part A (Single-ascending Dose (SAD): Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 participants at risk
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 participants at risk
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 participants at risk
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 participants at risk
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 participants at risk
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
n=30 participants at risk
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
n=9 participants at risk
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
n=6 participants at risk
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
n=6 participants at risk
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
n=12 participants at risk
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
n=6 participants at risk
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular embryonal carcinoma
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular malignant teratoma
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
Other adverse events
| Measure |
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)
n=6 participants at risk
Cohort A1 (SAD): Single iv bolus dose of KAE609 10.5 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)
n=6 participants at risk
Cohort A2 (SAD): Single iv bolus dose of KAE609 30 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)
n=6 participants at risk
Cohort A3 (SAD): Single iv infusion dose of KAE609 75 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)
n=6 participants at risk
Cohort A4 (SAD): Single iv infusion dose of KAE609 120 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)
n=6 participants at risk
Cohort A5 (SAD): Single iv infusion dose of KAE609 210 mg administered at the clinical site by the study personnel.
|
Part A (Single-ascending Dose (SAD): Pooled KAE609
n=30 participants at risk
All KAE609-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part A (Single-ascending Dose (SAD): Pooled Placebo
n=9 participants at risk
All placebo-treated patients from Part A (Single-ascending dose (SAD) cohorts (cohort A1, cohort A2, cohort A3, cohort A4 and cohort A5)
|
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)
n=6 participants at risk
Cohort B1 (MAD): Multiple iv bolus doses of KAE609 (60 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)
n=6 participants at risk
Cohort B2 (MAD): Multiple iv infusion doses of KAE609 (120 mg, every 24 hours (q24h) × 5 days) administered at the clinical site by the study personnel.
|
Part B (Multiple-ascending Dose (MAD): Pooled KAE609
n=12 participants at risk
All KAE609-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
Part B (Multiple-ascending Dose (MAD): Pooled Placebo
n=6 participants at risk
All placebo-treated patients from Part B (Multiple-ascending dose (MAD) cohorts (cohort B1 and cohort B2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
2/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
6.7%
2/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
General disorders
Catheter site oedema
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
11.1%
1/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
2/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
General disorders
Infusion site discomfort
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
11.1%
1/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
6.7%
2/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
50.0%
3/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
66.7%
4/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
58.3%
7/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
13.3%
4/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
3/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
33.3%
2/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
50.0%
3/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
41.7%
5/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Reproductive system and breast disorders
Semen discolouration
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
50.0%
3/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
13.3%
4/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
11.1%
1/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
8.3%
1/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
16.7%
1/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
3.3%
1/30 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/9 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/12 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
0.00%
0/6 • On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.
Any sign or symptom that occurs during the treatment period plus 30 days post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER