Trial Outcomes & Findings for Phase 1 Study of SAR440894 vs Placebo (NCT NCT04441905)
NCT ID: NCT04441905
Last Updated: 2026-01-13
Results Overview
The number of participants who experienced at least one unsolicited AE. An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as an AE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as an AE. For participants who enrolled prior to protocol v11.0, AEs were assessed with protocol defined criteria. For participants who enrolled under protocol v11.0, AEs were assessed with NCI CTCAE, Version 5.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Day 1 through Day 150
Results posted on
2026-01-13
Participant Flow
The study population included healthy male and female adults, ages 18-45, inclusive, who met all eligibility criteria. Participants were enrolled at three sites in the United States between December 14, 2020 and March 25, 2024 and were recruited via IRB-approved procedure and materials, such as a participant-recruitment database, websites, outreach events, and electronic or other media.
Participant milestones
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
7
|
10
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Enrolled but treatment not administered
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Became ineligible after enrollment
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1 Study of SAR440894 vs Placebo
Baseline characteristics by cohort
| Measure |
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=7 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=7 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 8.9 • n=123 Participants
|
37.2 years
STANDARD_DEVIATION 5.2 • n=123 Participants
|
32.2 years
STANDARD_DEVIATION 7.9 • n=210 Participants
|
39.0 years
STANDARD_DEVIATION 5.3 • n=19 Participants
|
31.6 years
STANDARD_DEVIATION 7.2 • n=615 Participants
|
28.9 years
STANDARD_DEVIATION 8.0 • n=20 Participants
|
33.7 years
STANDARD_DEVIATION 7.8 • n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=123 Participants
|
4 Participants
n=123 Participants
|
3 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
3 Participants
n=615 Participants
|
5 Participants
n=20 Participants
|
23 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=123 Participants
|
2 Participants
n=123 Participants
|
3 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
4 Participants
n=615 Participants
|
5 Participants
n=20 Participants
|
19 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=615 Participants
|
5 Participants
n=20 Participants
|
18 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=123 Participants
|
6 Participants
n=123 Participants
|
5 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
2 Participants
n=615 Participants
|
5 Participants
n=20 Participants
|
24 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=123 Participants
|
3 Participants
n=123 Participants
|
2 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=615 Participants
|
3 Participants
n=20 Participants
|
15 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=123 Participants
|
3 Participants
n=123 Participants
|
2 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
4 Participants
n=615 Participants
|
7 Participants
n=20 Participants
|
25 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
|
Body Mass Index (BMI)
|
27.95 kg/m^2
STANDARD_DEVIATION 4.41 • n=123 Participants
|
29.53 kg/m^2
STANDARD_DEVIATION 3.45 • n=123 Participants
|
26.12 kg/m^2
STANDARD_DEVIATION 4.42 • n=210 Participants
|
29.67 kg/m^2
STANDARD_DEVIATION 4.91 • n=19 Participants
|
26.94 kg/m^2
STANDARD_DEVIATION 3.66 • n=615 Participants
|
26.71 kg/m^2
STANDARD_DEVIATION 2.52 • n=20 Participants
|
27.74 kg/m^2
STANDARD_DEVIATION 3.87 • n=13 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one unsolicited AE. An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as an AE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as an AE. For participants who enrolled prior to protocol v11.0, AEs were assessed with protocol defined criteria. For participants who enrolled under protocol v11.0, AEs were assessed with NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Adverse Events (AEs)
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening adverse event * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant vital signs abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that met toxicity grading criteria. For participants who enrolled prior to protocol v11.0, vital signs results were graded according to protocol-defined toxicity criteria. For participant who enrolled under protocol v11.0, vital signs results were graded according to the NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Vital Signs Results
Systolic Blood Pressure (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Systolic Blood Pressure (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Heart Rate (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Diastolic Blood Pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Heart Rate (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Respiratory Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Vital Signs Results
Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant chemistry laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
ALT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Direct Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Cystatin-C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Sodium (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Sodium (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Potassium (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Potassium (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Bicarbonate (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Bicarbonate (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Glucose (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Glucose (High)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Blood Urea Nitrogen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
eGFR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Calcium (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Calcium (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Albumin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Total Protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
AST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Chemistry Laboratory Results
Total Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant hematology laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Hematology Laboratory Results
Hemoglobin (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Hemoglobin (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Basophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Monocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
WBC (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
WBC (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Lymphocytes (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Lymphocytes (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Eosinophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
Hematocrit
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Hematology Laboratory Results
RBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant coagulation laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Coagulation Laboratory Results
Prothrombin Time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Coagulation Laboratory Results
Activated Partial Thromboplastin Time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Coagulation Laboratory Results
INR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant urinalysis laboratory abnormality post-dosing is summarized by parameter. Clinical significance was determined by the site investigator for all results that were outside the normal range. For participants who enrolled prior to protocol v11.0, laboratory results were graded according to protocol-defined toxicity criteria. For participants who enrolled under protocol v11.0, laboratory results were graded according to the NCI CTCAE, Version 5.0.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Urine Protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Nitrite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Urine RBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Urobilinogen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Leukocyte Esterase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Urine Glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Occult Blood
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Urine WBC
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Clinically Significant Urinalysis Laboratory Results
Ketones
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The safety population includes participants who receive any amount of study product.
The number of participants who experienced at least one clinically significant ECG result post-dosing. Clinical significance was determined by the site investigator.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Frequency of Clinically Significant Electrocardiogram (ECG) Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of SAR440894 in Plasma
|
7.2444 ug/mL
Geometric Coefficient of Variation 34
|
29.1216 ug/mL
Geometric Coefficient of Variation 25
|
91.8476 ug/mL
Geometric Coefficient of Variation 8
|
307.1714 ug/mL
Geometric Coefficient of Variation 16
|
466.6280 ug/mL
Geometric Coefficient of Variation 14
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Minimum Concentration (Cmin) of SAR440894 in Plasma
|
1.1677 ug/mL
Geometric Coefficient of Variation 59
|
2.9886 ug/mL
Geometric Coefficient of Variation 20
|
5.1829 ug/mL
Geometric Coefficient of Variation 284
|
35.3937 ug/mL
Geometric Coefficient of Variation 33
|
59.7625 ug/mL
Geometric Coefficient of Variation 63
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Time of Maximum Concentration (Tmax) of SAR440894 in Plasma
|
2.10 h
Interval 1.0 to 49.0
|
2.05 h
Interval 1.0 to 2.3
|
5.00 h
Interval 1.0 to 9.3
|
3.65 h
Interval 1.0 to 9.0
|
2.00 h
Interval 1.0 to 2.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Time of Minimum Concentration (Tmin) of SAR440894 in Plasma
|
3097.0 h
Interval 342.0 to 3576.0
|
3542.5 h
Interval 1993.0 to 3578.0
|
3578.0 h
Interval 2666.0 to 3578.0
|
3530.5 h
Interval 3338.0 to 3676.0
|
3577.0 h
Interval 3485.0 to 3629.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the Lase Concentration Above the Lower Limit of Quantitation (AUC0-last) of SAR440894 in Plasma
|
5108.6 ug*h/mL
Geometric Coefficient of Variation 76
|
24191.0 ug*h/mL
Geometric Coefficient of Variation 11
|
68548.3 ug*h/mL
Geometric Coefficient of Variation 27
|
268599.9 ug*h/mL
Geometric Coefficient of Variation 23
|
437019.3 ug*h/mL
Geometric Coefficient of Variation 25
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=4 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=5 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SAR440894 in Plasma
|
9083.8 ug*h/mL
Geometric Coefficient of Variation 19
|
30661.2 ug*h/mL
Geometric Coefficient of Variation 11
|
85239.6 ug*h/mL
Geometric Coefficient of Variation 44
|
364777.5 ug*h/mL
Geometric Coefficient of Variation 27
|
693676.5 ug*h/mL
Geometric Coefficient of Variation 55
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=4 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=5 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Rate Constant (Lambda-z) of SAR440894 in Plasma
|
0.0004111 1/h
Geometric Coefficient of Variation 19
|
0.0004631 1/h
Geometric Coefficient of Variation 17
|
0.0005153 1/h
Geometric Coefficient of Variation 87
|
0.0003884 1/h
Geometric Coefficient of Variation 30
|
0.0002922 1/h
Geometric Coefficient of Variation 68
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=4 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=5 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of SAR440894 in Plasma
|
1687.0 h
Geometric Coefficient of Variation 19
|
1497.9 h
Geometric Coefficient of Variation 17
|
1344.0 h
Geometric Coefficient of Variation 87
|
1784.0 h
Geometric Coefficient of Variation 30
|
2373.0 h
Geometric Coefficient of Variation 68
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=4 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=5 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Clearance (CL) of SAR440894 in Plasma
|
0.0331 mL/h/kg
Geometric Coefficient of Variation 19
|
0.0328 mL/h/kg
Geometric Coefficient of Variation 11
|
0.0352 mL/h/kg
Geometric Coefficient of Variation 44
|
0.0275 mL/h/kg
Geometric Coefficient of Variation 27
|
0.0288 mL/h/kg
Geometric Coefficient of Variation 55
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The PK Population includes all participants who received a complete dose of SAR440894 and have at least one quantifiable post-dose plasma drug concentration record.
PK parameters were estimated from the SAR440894 plasma concentration-time data after a complete dose using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=4 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=5 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of SAR440894 in Plasma
|
80.38 mL/kg
Geometric Coefficient of Variation 29
|
70.47 mL/kg
Geometric Coefficient of Variation 20
|
68.25 mL/kg
Geometric Coefficient of Variation 39
|
70.55 mL/kg
Geometric Coefficient of Variation 34
|
98.72 mL/kg
Geometric Coefficient of Variation 18
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The Immunogenicity Population includes all participants who receive any amount of study product and contribute at least one post-infusion plasma sample for immunogenicity testing for which valid results are reported.
Incidence of ADA is defined as either treatment-induced or treatment-boosted ADA at any time point post dosing. For immunogenicity assays, a positive result is defined as a positive screening assay followed by a positive confirmation assay. Treatment-induced ADA is defined as a negative result at baseline and a positive result post-dose. Treatment-boosted ADA is defined as a positive result at both baseline and post-dose, with a 4-fold increase in titer.
Outcome measures
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=5 Participants
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 Participants
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 Participants
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 Participants
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 Participants
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 Participants
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibody (ADA) Assay Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 - SAR440894 0.3 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 - SAR440894 1 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 - SAR440894 3 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 - SAR440894 10 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 - SAR440894 20 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 - SAR440894 0.3 mg/kg
n=6 participants at risk
0.3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 2 - SAR440894 1 mg/kg
n=6 participants at risk
1 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 3 - SAR440894 3 mg/kg
n=6 participants at risk
3 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 4 - SAR440894 10 mg/kg
n=6 participants at risk
10 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Cohort 5 - SAR440894 20 mg/kg
n=6 participants at risk
20 mg/kg of SAR440894 administered once during a 60-minute intravenous (IV) infusion.
SAR440894: One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
Placebo
n=10 participants at risk
Placebo participants from Cohorts 1, 2, 3, 4, and 5. Placebo was administered by the same route as active drug.
Placebo: One time 60-minute IV infusion of lyophilized placebo for SAR440894
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
33.3%
2/6 • Number of events 3 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 3 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
General disorders
Asthenia
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
General disorders
Injection site irritation
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
20.0%
2/10 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Bilirubin conjugated increased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood albumin decreased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
33.3%
2/6 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood calcium decreased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood calcium increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood glucose increased
|
66.7%
4/6 • Number of events 17 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
50.0%
3/6 • Number of events 3 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
40.0%
4/10 • Number of events 11 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood potassium decreased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood pressure systolic increased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Blood sodium decreased
|
50.0%
3/6 • Number of events 8 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
33.3%
2/6 • Number of events 9 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
20.0%
2/10 • Number of events 6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Glucose urine present
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Haemoglobin decreased
|
33.3%
2/6 • Number of events 9 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Heart rate decreased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
20.0%
2/10 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
20.0%
2/10 • Number of events 8 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Red blood cells urine positive
|
33.3%
2/6 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
50.0%
3/6 • Number of events 4 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
20.0%
2/10 • Number of events 6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
Respiratory rate increased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
30.0%
3/10 • Number of events 3 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 2 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
10.0%
1/10 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/6 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
0.00%
0/10 • All AEs were documented from time of drug administration (Day 1) through the time of the last assessment (Day 150).
For participants who enrolled prior to protocol v11.0, AEs were graded according to protocol-defined toxicity criteria, and all abnormal laboratory and vital signs findings that met grading criteria were considered AEs. For participants who enrolled under protocol v11.0, AEs were graded according to the NCI CTCAE, Version 5.0, and only clinically significant or related abnormal laboratory or vital signs findings were considered AEs.
|
Additional Information
Kristie Miller, MD
Pharmaceutical Product Development (PPD), part of Thermo Fisher Scientific
Phone: 512-747-1504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60