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A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (DPIV-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01666652
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Dengue Fever
Interventions Biological: 4 µg TDENV-PIV with Alum adjuvant
Biological: 1 µg TDENV-PIV with AS03B1 adjuvant
Other: Phosphate buffered saline
Biological: 1 µg TDENV-PIV with Alum adjuvant
Biological: 1 µg TDENV-PIV with AS01E1 adjuvant
Enrollment 100
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Period Title: Overall Study
Started 20 20 20 20 20
Completed 18 19 19 16 19
Not Completed 2 1 1 4 1
Reason Not Completed
Serious Adverse Event             0             0             0             1             0
Withdrawal by Subject             0             0             0             0             1
Moved from study area             1             0             0             2             0
Lost to Follow-up             1             1             1             1             0
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo Total
Hide Arm/Group Description

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 20 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
28.2  (5.68) 26.1  (4.55) 28.0  (6.86) 28.4  (5.56) 28.3  (5.47) 27.8  (5.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
Female
11
  55.0%
7
  35.0%
7
  35.0%
11
  55.0%
7
  35.0%
43
  43.0%
Male
9
  45.0%
13
  65.0%
13
  65.0%
9
  45.0%
13
  65.0%
57
  57.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
American Indian or Alaskan Native
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
2
   2.0%
Asian-Central/South Asian
0
   0.0%
1
   5.0%
1
   5.0%
2
  10.0%
0
   0.0%
4
   4.0%
Asian-East Asian
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
White-Caucasian/European
10
  50.0%
4
  20.0%
4
  20.0%
8
  40.0%
8
  40.0%
34
  34.0%
Other
1
   5.0%
2
  10.0%
2
  10.0%
1
   5.0%
2
  10.0%
8
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
20 20 20 20 20 100
1.Primary Outcome
Title Number of Subjects With Adverse Events Within the 28 Day Follow-up
Hide Description Number of subjects with adverse events occurring within days 0-28 following vaccination
Time Frame Days 0-28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with any AEs
10
  50.0%
9
  45.0%
10
  50.0%
14
  70.0%
15
  75.0%
Upper respiratory tract infection
0
   0.0%
2
  10.0%
0
   0.0%
3
  15.0%
0
   0.0%
Nasopharyngitis
2
  10.0%
0
   0.0%
0
   0.0%
2
  10.0%
2
  10.0%
Neutrophil count decreased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  15.0%
Bradycardia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
Chills
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
Tachycardia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
White blood cell count increased
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
2.Primary Outcome
Title Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)
Hide Description Overall incidence of any symptoms (solicited and unsolicited) reported during the 7-day (days 0-6) post vaccination period in TVC population
Time Frame Days 0-6 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 18 19 20 20
Measure Type: Number
Unit of Measure: AEs
Dose 1 8 12 15 20 13
Dose 2 7 9 15 15 11
3.Primary Outcome
Title Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Hide Description Incidence 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).
Time Frame Days 0-6 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 18 19 20 20
Measure Type: Number
Unit of Measure: AEs
Dose 1 8 10 12 14 12
Dose 2 2 7 10 14 11
4.Primary Outcome
Title Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
Hide Description Incidence 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.
Time Frame Days 0-6 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 18 19 20 20
Measure Type: Number
Unit of Measure: AEs
Dose 1 6 7 15 17 2
Dose 2 5 6 14 12 2
5.Primary Outcome
Title Summary of Subjects With Serious Adverse Events
Hide Description Summary of subjects with serious adverse events through out the study
Time Frame days 0-392
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Asthma
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Miscarriage
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Worsening abdominla discomfort
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Gunshot wound
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
6.Secondary Outcome
Title Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
Hide Description

The 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

Time Frame day 56 visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TDENV-PIV alum1 TDENV-PIV alum4 TDENV-PIV AS01E1 TDENV-PIV AS03B1 Placebo
Hide Arm/Group Description:

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with Alum adjuvant

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

4 µg TDENV-PIV with Alum adjuvant

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS01E1 adjuvant

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

1 µg TDENV-PIV with AS03B1 adjuvant

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Phosphate buffered saline

Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
ALAT: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT: PRE Below LLN
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
19
  95.0%
19
  95.0%
20
 100.0%
Grade 1-2
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT: PI(D7) Below LLN
0
   0.0%
1
   5.0%
1
   5.0%
2
  10.0%
1
   5.0%
Normal
20
 100.0%
18
  90.0%
19
  95.0%
18
  90.0%
19
  95.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
17
  85.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
Normal
20
 100.0%
18
  90.0%
19
  95.0%
18
  90.0%
19
  95.0%
Grade 1-2
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
18
  90.0%
19
  95.0%
Grade 1-2
1
   5.0%
00
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: PI(D28) Below LLN
1
   5.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: PII(D35) Below LLN
1
   5.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AP: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Normal
20
 100.0%
18
  90.0%
18
  90.0%
20
 100.0%
18
  90.0%
Grade 1-2
0
   0.0%
2
  10.0%
2
  10.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
19
  95.0%
18
  90.0%
Grade 1-2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT: PII(D35) Below LLN
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
16
  80.0%
18
  90.0%
19
  95.0%
20
 100.0%
Grade 1-2
1
   5.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
ASAT: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
18
  90.0%
17
  85.0%
20
 100.0%
19
  95.0%
19
  95.0%
Grade 1-2
2
  10.0%
2
  10.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: SCR Below LLN
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: PRE Below LLN
1
   5.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: PI(D7) Below LLN
0
   0.0%
1
   5.0%
1
   5.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
19
  95.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: PI(D28) Below LLN
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: PII(D35) Below LLN
0
   0.0%
1
   5.0%
1
   5.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
18
  90.0%
19
  95.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
18
  90.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
19
  95.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
19
  95.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: SCR Below LLN
0
   0.0%
2
  10.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
17
  85.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: PRE Below LLN
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
18
  90.0%
20
 100.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: PI(D7) Below LLN
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
17
  85.0%
19
  95.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
1
   5.0%
1
   5.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: PI(D28) Below LLN
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
17
  85.0%
18
  90.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: PII(D35) Below LLN
1
   5.0%
2
  10.0%
0
   0.0%
0
   0.0%
1
   5.0%
Normal
19
  95.0%
17
  85.0%
19
  95.0%
19
  95.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: PII(D56) Below LLN
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
17
  85.0%
19
  95.0%
18
  90.0%
20
 100.0%
Grade 1-2
1
   5.0%
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
18
  90.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
2
  10.0%
2
  10.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
18
  90.0%
17
  85.0%
20
 100.0%
Grade 1-2
1
   5.0%
1
   5.0%
2
  10.0%
3
  15.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
17
  85.0%
18
  90.0%
16
  80.0%
20
 100.0%
Grade 1-2
0
   0.0%
2
  10.0%
2
  10.0%
3
  15.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
15
  75.0%
18
  90.0%
17
  85.0%
18
  90.0%
Grade 1-2
0
   0.0%
4
  20.0%
2
  10.0%
2
  10.0%
2
  10.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
16
  80.0%
19
  95.0%
17
  85.0%
20
 100.0%
Grade 1-2
0
   0.0%
3
  15.0%
1
   5.0%
2
  10.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
18
  90.0%
20
 100.0%
18
  90.0%
19
  95.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
19
  95.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
17
  85.0%
20
 100.0%
19
  95.0%
Grade 1-2
0
   0.0%
1
   5.0%
2
  10.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
19
  95.0%
19
  95.0%
15
  75.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
3
  15.0%
Above ULN
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
2
  10.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
18
  90.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
18
  90.0%
20
 100.0%
19
  95.0%
17
  85.0%
Grade 1-2
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Neutrophils: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
17
  85.0%
18
  90.0%
17
  85.0%
Grade 1-2
0
   0.0%
0
   0.0%
1
   5.0%
1
   5.0%
3
  15.0%
Above ULN
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
20
 100.0%
19
  95.0%
20
 100.0%
19
  95.0%
Grade 1-2
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
18
  90.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
19
  95.0%
20
 100.0%
18
  90.0%
20
 100.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
19
  95.0%
20
 100.0%
19
  95.0%
19
  95.0%
Grade 1-2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
17
  85.0%
20
 100.0%
20
 100.0%
18
  90.0%
Grade 1-2
0
   0.0%
3
  15.0%
0
   0.0%
0
   0.0%
2
  10.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
18
  90.0%
18
  90.0%
20
 100.0%
18
  90.0%
Grade 1-2
1
   5.0%
2
  10.0%
2
  10.0%
0
   0.0%
2
  10.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: PI(D7) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
19
  95.0%
18
  90.0%
17
  85.0%
19
  95.0%
15
  75.0%
Grade 1-2
1
   5.0%
2
  10.0%
3
  15.0%
1
   5.0%
5
  25.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: PI(D28) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%
18
  90.0%
18
  90.0%
19
  95.0%
20
 100.0%
Grade 1-2
0
   0.0%
1
   5.0%
2
  10.0%
0
   0.0%
0
   0.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: PII(D35) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
18
  90.0%
16
  80.0%
19
  95.0%
19
  95.0%
17
  85.0%
Grade 1-2
2
  10.0%
3
  15.0%
1
   5.0%
0
   0.0%
3
  15.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells: PII(D56) Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
18
  90.0%
19
  95.0%
17
  85.0%
19
  95.0%
17
  85.0%
Grade 1-2
2
  10.0%
0
   0.0%
3
  15.0%
0
   0.0%
3
  15.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   5.0%
0
   0.0%
1
   5.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bilibrubin: SCR Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Normal
20
 100.0%
20
 100.0%
20
 100.0%
19
  95.0%
19
  95.0%
Grade 1-2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Above ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 or more
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bilirubin: PRE Below LLN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Normal
20
 100.0%