Trial Outcomes & Findings for A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (NCT NCT01666652)
NCT ID: NCT01666652
Last Updated: 2019-01-25
Results Overview
Number of subjects with adverse events occurring within days 0-28 following vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
Days 0-28
Results posted on
2019-01-25
Participant Flow
This study enrolled healthy male and non-pregnant, non-breast-feeding, female subjects between the ages of 18 and 39 (inclusive). Subjects were enrolled at the CTC, WRAIR, Silver Spring, Maryland, US. Subjects were not screened for prior flavivirus infection.
Participant milestones
| Measure |
TDENV-PIV alum1
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
19
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
TDENV-PIV alum1
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Moved from study area
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
Baseline characteristics by cohort
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 4.55 • n=7 Participants
|
28.0 years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 5.56 • n=4 Participants
|
28.3 years
STANDARD_DEVIATION 5.47 • n=21 Participants
|
27.8 years
STANDARD_DEVIATION 5.62 • n=10 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
20 participants
n=21 Participants
|
100 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Days 0-28Number of subjects with adverse events occurring within days 0-28 following vaccination
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Subjects with any AEs
|
10 Participants
|
9 Participants
|
10 Participants
|
14 Participants
|
15 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Upper respiratory tract infection
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Nasopharyngitis
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Chills
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
Tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events Within the 28 Day Follow-up
White blood cell count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Days 0-6 post vaccinationOverall incidence of any symptoms (solicited and unsolicited) reported during the 7-day (days 0-6) post vaccination period in TVC population
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=18 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=19 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)
Dose 1
|
8 AEs
|
12 AEs
|
15 AEs
|
20 AEs
|
13 AEs
|
|
Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)
Dose 2
|
7 AEs
|
9 AEs
|
15 AEs
|
15 AEs
|
11 AEs
|
PRIMARY outcome
Timeframe: Days 0-6 post vaccinationIncidence of General Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period for TVC population. General symptoms are described as fatigue, gastrointestinal symptoms, headache, joint pain, muscle aches and increased temperature (oral).
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=18 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=19 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Dose 1
|
8 AEs
|
10 AEs
|
12 AEs
|
14 AEs
|
12 AEs
|
|
Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Dose 2
|
2 AEs
|
7 AEs
|
10 AEs
|
14 AEs
|
11 AEs
|
PRIMARY outcome
Timeframe: Days 0-6 post vaccinationIncidence of Local Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period in TVC population. Local symptoms are described as pain, redness and swelling.
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=18 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=19 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Dose 1
|
6 AEs
|
7 AEs
|
15 AEs
|
17 AEs
|
2 AEs
|
|
Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Dose 2
|
5 AEs
|
6 AEs
|
14 AEs
|
12 AEs
|
2 AEs
|
PRIMARY outcome
Timeframe: days 0-392Summary of subjects with serious adverse events through out the study
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Summary of Subjects With Serious Adverse Events
Asthma
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Subjects With Serious Adverse Events
Miscarriage
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Summary of Subjects With Serious Adverse Events
Worsening abdominla discomfort
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Summary of Subjects With Serious Adverse Events
Gunshot wound
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 56 visitThe percentage of subjects with hematological and biochemical laboratory values within and outside the normal ranges and with different grade of AE were tabulated with exact 95% CI at baseline and at each specified timepoint. Safety laboratory assays were performed at a WRAIR-designated Clinical Laboratory Improvement Amendments-certified laboratory. All safety-related clinical laboratory values were reviewed and all abnormal values were assessed by the investigators as clinically significant or not, with respect to safety. PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D35) = Post-dose 2, Day 35 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Below LLN
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Normal
|
20 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Normal
|
20 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Grade 1-2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Normal
|
20 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Grade 1-2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Creatinine: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Below LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Normal
|
20 Participants
|
17 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Below LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Normal
|
20 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Below LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Normal
|
20 Participants
|
17 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Grade 1-2
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Below LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Normal
|
20 Participants
|
17 Participants
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Below LLN
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Normal
|
19 Participants
|
17 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Below LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Normal
|
19 Participants
|
17 Participants
|
19 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Grade 1-2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Eosinophils: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Normal
|
20 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Grade 1-2
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Normal
|
19 Participants
|
19 Participants
|
18 Participants
|
17 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Grade 1-2
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Normal
|
20 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Grade 1-2
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
17 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Normal
|
20 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Grade 1-2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Grade 1-2
|
1 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Below LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Below LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
AP: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Normal
|
20 Participants
|
18 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Grade 1-2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Grade 1-2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Below LLN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Normal
|
19 Participants
|
16 Participants
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Grade 1-2
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Normal
|
20 Participants
|
15 Participants
|
18 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Grade 1-2
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Normal
|
20 Participants
|
16 Participants
|
19 Participants
|
17 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Grade 1-2
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Normal
|
18 Participants
|
17 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hemoglobin: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Grade 1-2
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ASAT: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Below LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Normal
|
20 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Below LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Below LLN
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Normal
|
20 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Normal
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Below LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
BUN: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Normal
|
19 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Above ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Grade 1-2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Above ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Normal
|
20 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Normal
|
20 Participants
|
19 Participants
|
19 Participants
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Lymphocytes: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Normal
|
20 Participants
|
19 Participants
|
17 Participants
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Grade 1-2
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Normal
|
20 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Neutrophils: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Grade 1-2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Platelets: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Normal
|
20 Participants
|
17 Participants
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Grade 1-2
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Normal
|
19 Participants
|
18 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Grade 1-2
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Normal
|
19 Participants
|
18 Participants
|
17 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Grade 1-2
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Normal
|
20 Participants
|
18 Participants
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Grade 1-2
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Normal
|
18 Participants
|
16 Participants
|
19 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Grade 1-2
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Normal
|
18 Participants
|
19 Participants
|
17 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Grade 1-2
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
White blood cells: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilibrubin: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D7) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PI(D28) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Below LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Normal
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D35) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Normal
|
20 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Total bilirubin: PII(D56) · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Below LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Normal
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Grade 1-2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: SCR · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Below LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Normal
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Grade 1-2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PRE · Grade 3 or more
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Below LLN
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Normal
|
20 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Grade 1-2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
ALAT: PI(D7) · Above ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to month 13Population: subjects with available data
Geometric Mean Titers (GMTs) of Neutralizing antibody titers specific to each DENV type were measured by a quantitative microneutralization assay with a titer giving 50% reduction in viral infection (MN50) at specified time points. MN50 is specific and sensitive for the detection of anti-DENV neutralizing antibodies. The cut-off for seropositivity was 1: 10 for neutralizing antibody titers measured by MN50 assay. MN50 assay was used to determine initial DENV antibody status of subjects for inclusion in the ATP cohort. PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PRE
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PI(D7)
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PI(D28)
|
7.4 GMT
Interval 5.5 to 10.1
|
16.7 GMT
Interval 9.3 to 29.9
|
32.4 GMT
Interval 14.8 to 71.0
|
28.9 GMT
Interval 13.7 to 60.7
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PII(D56)
|
64.3 GMT
Interval 39.9 to 103.5
|
180.4 GMT
Interval 122.6 to 265.4
|
335.8 GMT
Interval 188.3 to 599.0
|
577.8 GMT
Interval 340.3 to 981.4
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PII(M4)
|
17.8 GMT
Interval 9.5 to 33.4
|
129.6 GMT
Interval 60.3 to 278.4
|
182.8 GMT
Interval 90.7 to 368.7
|
247.6 GMT
Interval 128.1 to 478.6
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PII(M7)
|
7.2 GMT
Interval 5.2 to 9.9
|
13.6 GMT
Interval 8.9 to 20.8
|
21.5 GMT
Interval 9.7 to 47.5
|
32.8 GMT
Interval 18.6 to 57.8
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PII(M10)
|
7.3 GMT
Interval 4.9 to 10.8
|
14.5 GMT
Interval 10.3 to 20.4
|
35.7 GMT
Interval 11.9 to 106.9
|
24.3 GMT
Interval 13.2 to 44.9
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den1: PII(M13)
|
7.9 GMT
Interval 5.3 to 12.0
|
13.2 GMT
Interval 8.6 to 20.4
|
31.2 GMT
Interval 9.6 to 101.2
|
24.9 GMT
Interval 11.8 to 52.6
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PRE
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PI(D7)
|
5.0 GMT
Interval 5.0 to 5.0
|
5.8 GMT
Interval 4.2 to 8.2
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PI(D28)
|
5.2 GMT
Interval 4.8 to 5.7
|
18.1 GMT
Interval 9.7 to 33.7
|
19.8 GMT
Interval 8.2 to 48.0
|
15.9 GMT
Interval 8.3 to 30.5
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PII(D56)
|
44.2 GMT
Interval 23.5 to 83.3
|
159.3 GMT
Interval 96.2 to 263.8
|
361.4 GMT
Interval 188.2 to 694.1
|
373.3 GMT
Interval 194.7 to 715.6
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PII(M4)
|
7.9 GMT
Interval 5.7 to 10.8
|
23.1 GMT
Interval 11.2 to 47.8
|
46.6 GMT
Interval 23.4 to 93.0
|
47.2 GMT
Interval 26.0 to 85.7
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PII(M7)
|
5.9 GMT
Interval 4.6 to 7.5
|
14.0 GMT
Interval 8.5 to 23.2
|
19.9 GMT
Interval 8.6 to 46.1
|
22.6 GMT
Interval 12.3 to 41.5
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den2: PII(M10)
|
6.4 GMT
Interval 4.4 to 9.3
|
9.4 GMT
Interval 5.5 to 16.0
|
43.6 GMT
Interval 15.7 to 121.4
|
16.8 GMT
Interval 9.1 to 31.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den: PII(M13)
|
7.2 GMT
Interval 4.7 to 11.1
|
9.4 GMT
Interval 6.0 to 14.6
|
27.3 GMT
Interval 11.0 to 67.6
|
17.1 GMT
Interval 8.6 to 34.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PRE
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PI(D7)
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PI(D28)
|
5.3 GMT
Interval 4.6 to 6.2
|
14.7 GMT
Interval 8.3 to 26.0
|
20.0 GMT
Interval 9.5 to 42.1
|
14.1 GMT
Interval 6.8 to 29.4
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PII(D56)
|
65.6 GMT
Interval 41.1 to 104.8
|
188.9 GMT
Interval 119.5 to 298.7
|
431.5 GMT
Interval 222.0 to 838.7
|
495.5 GMT
Interval 317.6 to 773.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PII(M4)
|
13.2 GMT
Interval 7.9 to 21.8
|
60.4 GMT
Interval 35.8 to 101.7
|
135.4 GMT
Interval 71.6 to 255.9
|
129.6 GMT
Interval 68.0 to 246.8
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PII(M7)
|
5.8 GMT
Interval 4.7 to 7.1
|
13.4 GMT
Interval 9.4 to 19.2
|
21.0 GMT
Interval 9.6 to 46.0
|
29.5 GMT
Interval 13.8 to 62.8
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PII(M10)
|
6.0 GMT
Interval 4.6 to 7.8
|
9.1 GMT
Interval 6.0 to 13.9
|
36.7 GMT
Interval 12.4 to 108.9
|
20.7 GMT
Interval 10.7 to 40.1
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den3: PII(M13)
|
5.7 GMT
Interval 4.6 to 7.1
|
9.5 GMT
Interval 6.1 to 14.7
|
36.7 GMT
Interval 14.9 to 90.8
|
24.0 GMT
Interval 11.6 to 49.8
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PRE
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PI(D7)
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PI(D28)
|
5.3 GMT
Interval 4.6 to 6.2
|
8.2 GMT
Interval 4.1 to 16.4
|
6.7 GMT
Interval 4.3 to 10.6
|
7.4 GMT
Interval 4.1 to 13.2
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PII(D56)
|
26.0 GMT
Interval 10.8 to 62.3
|
162.7 GMT
Interval 67.0 to 394.9
|
201.7 GMT
Interval 66.2 to 614.8
|
462.3 GMT
Interval 217.6 to 981.9
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PII(M4)
|
5.9 GMT
Interval 4.9 to 7.2
|
12.9 GMT
Interval 7.2 to 23.0
|
17.6 GMT
Interval 7.5 to 41.2
|
29.8 GMT
Interval 13.4 to 66.2
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PII(M7)
|
6.0 GMT
Interval 4.8 to 7.5
|
9.1 GMT
Interval 5.2 to 15.8
|
7.5 GMT
Interval 3.8 to 15.0
|
15.2 GMT
Interval 6.7 to 34.6
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PII(M10)
|
5.8 GMT
Interval 4.7 to 7.1
|
7.1 GMT
Interval 4.6 to 11.0
|
11.0 GMT
Interval 4.4 to 27.1
|
6.8 GMT
Interval 4.6 to 10.0
|
5.0 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
MN Ab Den4: PII(M13)
|
5.3 GMT
Interval 4.7 to 6.1
|
7.3 GMT
Interval 4.2 to 12.8
|
9.3 GMT
Interval 3.9 to 22.2
|
8.2 GMT
Interval 4.7 to 14.3
|
5.0 GMT
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: up to month 13Population: subjects with available results for all four DENV-types (without missing N antibody titer)
Number of subjects showing Monovalent, bivalent, trivalent and tetravalent response for neutralizing antibodies by Microneutralization Titer (giving 50% reduction in viral infection (MN50)) in the TVC population. PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit
Outcome measures
| Measure |
TDENV-PIV alum1
n=20 Participants
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 Participants
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 Participants
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 Participants
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 Participants
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PRE · Monovalent
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PRE · Bivalent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PRE · Trivalent
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PRE · Tetravalent
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D7) · None
|
20 Participants
|
18 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D7) · Monovalent
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D7) · Bivalent
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D7) · Trivalent
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D7) · Tetravalent
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D28) · None
|
14 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
18 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D28) · Monovalent
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D28) · Bivalent
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D28) · Trivalent
|
1 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PI(D28) · Tetravalent
|
0 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(56) · None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
18 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(56) · Monovalent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(56) · Bivalent
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(56) · Trivalent
|
7 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(56) · Tetravalent
|
12 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M4) · None
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
17 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M4) · Monovalent
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M4) · Bivalent
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M4) · Trivalent
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M4) · Tetravalent
|
3 Participants
|
10 Participants
|
11 Participants
|
14 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M7) · None
|
12 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
17 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M7) · Monovalent
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M7) · Bivalent
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M7) · Trivalent
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M7) · Tetravalent
|
1 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M10) · None
|
15 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
17 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M10) · Monovalent
|
2 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M10) · Bivalent
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M10) · Trivalent
|
0 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M10) · Tetravalent
|
2 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M13) · None
|
12 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
17 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M13) · Monovalent
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M13) · Bivalent
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PRE · None
|
20 Participants
|
19 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M13) · Trivalent
|
1 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
PII(M13) · Tetravalent
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
TDENV-PIV alum1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
TDENV-PIV alum4
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TDENV-PIV AS01E1
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
TDENV-PIV AS03B1
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDENV-PIV alum1
n=20 participants at risk
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 participants at risk
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 participants at risk
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 participants at risk
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 participants at risk
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Reproductive system and breast disorders
Miscarriage
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Gastrointestinal disorders
Worsening abdominal discomfort
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Injury, poisoning and procedural complications
Gunshot wound
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
Other adverse events
| Measure |
TDENV-PIV alum1
n=20 participants at risk
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV alum4
n=20 participants at risk
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
4 µg TDENV-PIV with Alum adjuvant
|
TDENV-PIV AS01E1
n=20 participants at risk
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant
|
TDENV-PIV AS03B1
n=20 participants at risk
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant
|
Placebo
n=20 participants at risk
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
|
Injury, poisoning and procedural complications
Bruise at injection site
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Skin and subcutaneous tissue disorders
Rash on chest
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
10.0%
2/20 • Number of events 3 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
15.0%
3/20 • Number of events 3 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
|
Injury, poisoning and procedural complications
Contact dermatitis
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Decreased heart rate
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Decreased hemoglobin
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Decreased neutrophils
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
15.0%
3/20 • Number of events 4 • days 0-392
|
|
Investigations
Decreased platelets
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
30.0%
6/20 • Number of events 6 • days 0-392
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
|
Investigations
Direct bilirubin increased
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated creatinine
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated ALT
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated AST
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated heart rate
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated systolic blood pressure
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Investigations
Elevated WBC
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
General disorders
Flu like symptoms
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Nervous system disorders
Forgetfulness
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Injury, poisoning and procedural complications
Gunshot wound
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Investigations
Increased heart rate
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Investigations
Increased WBC
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Nervous system disorders
Left arm fell asleep
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Reproductive system and breast disorders
Menstrual cramps
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Reproductive system and breast disorders
Miscarriage
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness, back
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Musculoskeletal and connective tissue disorders
Neck pain, left side
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Psychiatric disorders
Nightmares
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Ear and labyrinth disorders
Otitis
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Injury, poisoning and procedural complications
Pain from skin abrasion, left knee
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Social circumstances
Pain, ear piercing
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Injury, poisoning and procedural complications
Pain, groin injury
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
General disorders
Right upper thigh pain
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
Sinus tenderness
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Infections and infestations
Strep throat
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
|
General disorders
Sweats
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Vascular disorders
Syncope vasovagal
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 2 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
15.0%
3/20 • Number of events 6 • days 0-392
|
10.0%
2/20 • Number of events 2 • days 0-392
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
|
Gastrointestinal disorders
Worsening abdominal discomfort
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Worsening uterin fibroids
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
0.00%
0/20 • days 0-392
|
5.0%
1/20 • Number of events 1 • days 0-392
|
0.00%
0/20 • days 0-392
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place