Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

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: NCT01966445
Recruitment Status : Completed
First Posted : October 21, 2013
Results First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Neoplasms
Intervention Biological: GSK2849330
Enrollment 29
Recruitment Details This is a Phase 1 study of anti-human epidermal growth factor receptor 3 (HER3) antibody, GSK2849330 in participants with advanced solid tumors expressing HER3. The study was conducted in 2 parts-Part1 (dose escalation) and Part2 (dose expansion). The starting dose in Part1 was 1.4 milligrams per kilogram (mg/kg) GSK2849330 given weekly for 28 days
Pre-assignment Details A total of 29 participants were randomized. The study was conducted in three countries. Participants in the GSK2849330 30 mg/kg weekly arm were not double counted with any other Arm.
Arm/Group Title Part1: GSK2849330 1.4 mg/kg Weekly Part1: GSK2849330 3 mg/kg Every 2 Weeks Part1: GSK2849330 3 mg/kg Weekly Part1: GSK2849330 10 mg/kg Every 2 Weeks Part1: GSK2849330 30 mg/kg Every 2 Weeks Part1: GSK2849330 30 mg/kg Weekly Part2: GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days. Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days. Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days. Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days.
Period Title: Part1 (Median Exposure of 6.143 Weeks)
Started 1 3 2 5 4 5 0
Completed 1 1 1 2 1 4 0
Not Completed 0 2 1 3 3 1 0
Reason Not Completed
Lost to Follow-up             0             0             0             2             0             1             0
Physician Decision             0             1             0             1             1             0             0
Withdrawal by Subject             0             1             1             0             2             0             0
Period Title: Part2 (Median Exposure of 7.143 Weeks)
Started 0 0 0 0 0 0 9
Completed 0 0 0 0 0 0 4
Not Completed 0 0 0 0 0 0 5
Reason Not Completed
Physician Decision             0             0             0             0             0             0             3
Withdrawal by Subject             0             0             0             0             0             0             2
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly Total
Hide Arm/Group Description Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days. Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days. Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days. Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort). Total of all reporting groups
Overall Number of Baseline Participants 1 3 2 5 4 14 29
Hide Baseline Analysis Population Description
Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants 29 participants
63.0 [1]   (NA) 62.3  (4.04) 46.0  (21.21) 66.2  (7.19) 58.3  (8.73) 62.5  (11.65) 61.4  (10.91)
[1]
Standard deviation for 1.4 mg/kg weekly arm could not be calculated as only a single participant was analyzed in this arm.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants 29 participants
Female
0
   0.0%
3
 100.0%
1
  50.0%
2
  40.0%
2
  50.0%
5
  35.7%
13
  44.8%
Male
1
 100.0%
0
   0.0%
1
  50.0%
3
  60.0%
2
  50.0%
9
  64.3%
16
  55.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants 29 participants
Asian-Central/South Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
1
   3.4%
White
1
 100.0%
3
 100.0%
2
 100.0%
5
 100.0%
4
 100.0%
13
  92.9%
28
  96.6%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Parts 1 and 2
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; and left ventricular ejection fraction (LVEF) meeting stopping criteria. AEs were collected in All Treated Population which comprised of all participants who received at least one dose of GSK2849330. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
1
 100.0%
3
 100.0%
2
 100.0%
5
 100.0%
4
 100.0%
14
 100.0%
SAEs
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
1
  25.0%
3
  21.4%
2.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)-Parts 1 and 2
Hide Description An event was considered a DLT if it occured within the first 4 weeks (28 days) of treatment, and met one of the following criteria unless it could be established that the event was unrelated to treatment: Grade 3 or greater non-hematologic toxicity; Grade 4 neutropenia lasting >5 days; Febrile neutropenia, of any grade or duration; Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia associated with bleeding; Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN; Any Grade 2 or greater toxicity that in the judgment of the investigator and GlaxoSmithKline (GSK) Medical Monitor, would be considered dose-limiting; Grade 3 or greater decrease in LVEF. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Parts 1 and 2
Hide Description Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (Total bil), calcium, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, magnesium, sodium, phosphorus, uric acid. Laboratory parameters were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. Data for worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
1
 100.0%
1
  33.3%
0
   0.0%
3
  60.0%
3
  75.0%
6
  42.9%
Albumin; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
Albumin; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP; any grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
1
 100.0%
0
   0.0%
1
  50.0%
1
  20.0%
1
  25.0%
7
  50.0%
ALP; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   7.1%
ALP; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
2
  66.7%
0
   0.0%
2
  40.0%
3
  75.0%
6
  42.9%
ALT; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
2
  40.0%
2
  50.0%
5
  35.7%
AST; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
AST; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bil; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
0
   0.0%
2
  14.3%
Total bil; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bil; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  50.0%
2
  14.3%
Calcium; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Calcium; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
1
  25.0%
2
  14.3%
Creatinine; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
GGT; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
1
 100.0%
0
   0.0%
1
  50.0%
2
  40.0%
3
  75.0%
8
  57.1%
GGT; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
1
  50.0%
1
  20.0%
0
   0.0%
3
  21.4%
GGT; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Glucose; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
1
 100.0%
0
   0.0%
1
  50.0%
3
  60.0%
2
  50.0%
4
  28.6%
Glucose; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
Potassium; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Magnesium; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
2
  50.0%
4
  28.6%
Magnesium; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Magnesium; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
3
  75.0%
4
  28.6%
Sodium; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phosphorus; any Grade increase; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  28.6%
Phosphorus; increase to Grade 3; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phosphorus; increase to Grade 4; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Uric acid; any Grade increase; n=0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
1
 100.0%
Uric acid; increase to Grade 3; n=0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Uric acid; increase to Grade 4; n=0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
1
 100.0%
4.Primary Outcome
Title Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Parts 1 and 2
Hide Description Blood samples were collected for the analysis of following clinical chemistry parameters: direct bilirubin (D.Bil.), cancer antigen (CA)-125, CA-15.3, CA19-9, chloride, carbon dioxide (CO2)/bicarbonate (HCO3), luteinizing hormone (LH), total protein and urea or blood urea nitrogen (BUN). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Number of participants with change from Baseline in clinical chemistry data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
D.Bil.; Decrease to Low; n=1,3,2,5,3,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 3 participants 14 participants
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
D.Bil.; increase to high; n=1,3,2,5,3,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 3 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
2
  40.0%
1
  33.3%
4
  28.6%
CA-125; Decrease to Low; n=1,3,0,5,4, 0 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CA-125; increase to high; n=1,3,0,5,4, 0 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CA 15.3; Decrease to Low; n=0, 0, 0, 0, 4, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 4 participants 0 participants
0
   0.0%
CA 15.3; increase to high; n=0, 0, 0, 0, 4, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 4 participants 0 participants
0
   0.0%
CA 19-9.; Decrease to Low; n=1,0,0,0,2,0 Number Analyzed 1 participants 0 participants 0 participants 0 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
CA 19-9; increase to high; n=1,0,0,0,2,0 Number Analyzed 1 participants 0 participants 0 participants 0 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
Chloride; Decrease to Low; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
2
  50.0%
4
  28.6%
Chloride; increase to high; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
CO2/HCO3.; Decrease to Low; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
  60.0%
1
  25.0%
2
  14.3%
CO2/HCO3; increase to high; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
0
   0.0%
7
  50.0%
LH; Decrease to Low; n=1,0,2,3,2,7 Number Analyzed 1 participants 0 participants 2 participants 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
LH; increase to high; n=1,0,2,3,2,7 Number Analyzed 1 participants 0 participants 2 participants 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  42.9%
Total Protein; Decrease to Low; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
1
  50.0%
1
  20.0%
0
   0.0%
1
   7.1%
Total Protein; increase to high; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
Urea/BUN; Decrease to Low; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
3
  21.4%
Urea/BUN; increase to high; n=1,3,2,5,4,14 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 14 participants
0
   0.0%
1
  33.3%
1
  50.0%
0
   0.0%
0
   0.0%
2
  14.3%
5.Primary Outcome
Title Number of Participants With Grade Change From Baseline in Hematology Data-Parts 1 and 2
Hide Description Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. Number of participants with any grade increase, increase to Grade 3 and increase to Grade 4 in hematology data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin; any Grade increase
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
3
  75.0%
7
  50.0%
Hemoglobin; increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  14.3%
Hemoglobin; increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes; any grade increase
0
   0.0%
0
   0.0%
1
  50.0%
3
  60.0%
1
  25.0%
5
  35.7%
Lymphocytes; increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  14.3%
Lymphocytes; increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total neutrophils; any Grade increase
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
1
   7.1%
Total neutrophils; increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total neutrophils; increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet; any Grade increase
0
   0.0%
1
  33.3%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet; increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet; increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC; any Grade increase
0
   0.0%
1
  33.3%
0
   0.0%
2
  40.0%
0
   0.0%
1
   7.1%
WBC; increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC; increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Parts 1 and 2
Hide Description Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscle hemoglobin concentration (MCHC), mean corpuscle hemoglobin (MCH), mean corpuscle volume (MCV), monocytes, red blood cell count (RBC) and reticulocytes. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as value at visit minus Baseline value. Number of participants with change from Baseline in hematology data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils: decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Basophils: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: decrease to low
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  14.3%
Hematocrit: decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
  25.0%
4
  28.6%
Hematocrit: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCHC: decrease to low
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  21.4%
MCHC: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCH: decrease to low
1
 100.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
MCH: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
MCV: decrease to low
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
MCV: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
Monocytes: decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes: increase to high
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  14.3%
RBC: decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
3
  60.0%
0
   0.0%
7
  50.0%
RBC: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
Reticulocytes: decrease to low
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
2
  14.3%
Reticulocytes: increase to high
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
2
  50.0%
3
  21.4%
7.Primary Outcome
Title Number of Participants With Change From Baseline in Urinalysis Data With Respect to Normal Range-Parts 1 and 2
Hide Description Urine samples were collected for the analysis of urine potential of hydrogen (pH) and urine specific gravity. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. The data for worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Urine pH; decrease to low; n=1, 3, 1, 5, 4, 7 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine pH; increase to high; n=1, 3, 1, 5, 4, 7 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
Specific gravity; decrease to low; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Specific gravity; increase to high; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Change From Baseline in Vital Signs-Parts 1 and 2
Hide Description Vital sign measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). Vital signs were graded according to NCI-CTCAE version 4.0. The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in HR (decrease to <60 beats per minute and increase to >100 beats per minute); increase in SBP from Baseline (>=120 to <140 millimeters of mercury [mmHg] Grade 1; >=140 to <160 mmHg [Grade 2]; >=160 [Grade 3]); increase in DBP from Baseline (>=80 to <90 [Grade 1]; >=90 to <100 [Grade 2]; >=100 mmHg [Grade 3]) and change in temperature from Baseline (increase to >=38 or decrease to <=35 degree Centigrade). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. The data for worst-case post Baseline is presented.
Time Frame Baseline and median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
HR; decrease to <60 beats per minute
1
 100.0%
1
  33.3%
0
   0.0%
2
  40.0%
0
   0.0%
4
  28.6%
HR; increase to >100 beats per minute
0
   0.0%
0
   0.0%
1
  50.0%
1
  20.0%
0
   0.0%
5
  35.7%
Temp; decrease to <=35 degree Celsius
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
Temp; increase to >=38 degree Celsius
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  28.6%
SBP; increase to Grade 1 (120-139 mmHg)
0
   0.0%
0
   0.0%
2
 100.0%
1
  20.0%
2
  50.0%
3
  21.4%
SBP; increase to Grade 2 (140-159 mmHg)
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
4
  28.6%
SBP; increase to Grade 3 (>=160 mmHg)
0
   0.0%
1
  33.3%
0
   0.0%
1
  20.0%
2
  50.0%
0
   0.0%
DBP; increase to Grade 1 (80-89 mmHg)
0
   0.0%
1
  33.3%
2
 100.0%
3
  60.0%
1
  25.0%
7
  50.0%
DBP; increase to Grade 2 (90-99 mmHg)
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
DBP; increase to Grade 3 (>=100 mmHg)
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
1
   7.1%
9.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Parts 1 and 2
Hide Description A 12-lead ECG was measured using an automated ECG machine after at least 5 minutes of rest for the participant in a semi-recumbent or supine position. Number of participants with abnormal ECG findings at any time post-Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-not clinically significant
1
 100.0%
3
 100.0%
1
  50.0%
4
  80.0%
3
  75.0%
4
  28.6%
Abnormal-clinically significant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
10.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of GSK2849330-Part 1
Hide Description The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data is defined as Cmax. Blood samples were collected at indicated time points. The analysis was performed on pharmacokinetic (PK) parameter population which comprised of all participants from the PK concentration population (participants who received at least one dose of GSK2849330 and for whom at least one post-dose PK sample was obtained and analyzed) for whom valid and valuable PK parameters were derived.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from Part 1 (dose-escalation cohort).
Overall Number of Participants Analyzed 1 3 2 3 3 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
29790.0 [1] 
(NA%)
62495.2
(34.8%)
83845.0
(24.1%)
233997.8
(2.7%)
639127.3
(45.4%)
778470.6
(14.5%)
[1]
The geometric coefficient of variation could not be calculated as a single participant was analyzed at the specified time point.
11.Secondary Outcome
Title Cmax of GSK2849330-Part 2
Hide Description PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.
Arm/Group Title GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly in Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Time of Occurrence of Cmax (Tmax) for GSK2849330-Part 1
Hide Description The time at which Cmax is observed was determined directly from the raw concentration-time data is defined as Tmax. Blood samples were collected at indicated time points for evaluation of pharmacokinetic parameters.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from Part 1 (dose-escalation cohort).
Overall Number of Participants Analyzed 1 3 2 3 3 5
Median (Full Range)
Unit of Measure: Hours
2.070
(2.070 to 2.070)
2.130
(2.000 to 6.170)
88.035
(6.370 to 169.700)
2.280
(2.130 to 6.000)
3.280
(2.300 to 6.230)
2.100
(1.830 to 2.330)
13.Secondary Outcome
Title Tmax for GSK2849330-Part 2
Hide Description PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.
Arm/Group Title GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly in Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Area Under the Concentration Time Curve (AUC) to a Fixed Nominal Time (AUC[0 to 168]) and AUC(0 to 336) for GSK2849330-Part 1
Hide Description The AUC to a fixed nominal time AUC(0-168) and AUC(0-336) were calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at indicated time points for determination of PK parameters.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from Part 1 (dose-escalation cohort).
Overall Number of Participants Analyzed 1 3 2 3 3 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
AUC(0 to 168); n=1, 3, 2, 3, 3, 5 Number Analyzed 1 participants 3 participants 2 participants 3 participants 3 participants 5 participants
1962762.0 [1] 
(NA%)
5787797.8
(27.2%)
618552.6
(20559.2%)
18185733.6
(28.8%)
54346531.5
(30.2%)
54388333.7
(22.6%)
AUC(0 to 336); 0, 3, 0, 3, 3, 0 Number Analyzed 0 participants 3 participants 0 participants 3 participants 3 participants 0 participants
7855808.8
(28.7%)
23409694.6
(39.4%)
72404738.6
(34.2%)
[1]
Geometric coefficient of variation could not be calculated as a single participant was analyzed at the specified time point.
15.Secondary Outcome
Title AUC(0 to 168) and AUC(0 to 336) for GSK2849330-Part 2
Hide Description PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.
Time Frame Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.
Arm/Group Title GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly in Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Serum HER3 From Tumor Tissue-Parts 1 and 2
Hide Description Pre-treatment and on-treatment biopsy tissues (tumor and normal skin) were analyzed for markers of HER3 pathway such as HER3 that may indicate a pharmacodynamic (PD) response to GSK2849330. Serum HER3 (soluble HER3) analyses was performed. The analysis was performed on PD population which comprised of all participants who received at least one dose of GSK2849330 and for whom at least one evaluable paired pre-treatment PD sample and on-treatment PD sample were obtained and analyzed. Mean and standard deviation for serum HER3 is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Day 1 (pre-dose, 1 hour, 6 hours), Day 2, Day 8, Day 15, Day 29 and follow-up (28 days post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 1 5 4 12
Mean (Standard Deviation)
Unit of Measure: Nanomoles
Day 1; pre-dose; n=1, 3, 1, 5, 4, 12 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 12 participants
13.65 [1]   (NA) 17.11  (2.603) 16.66 [1]   (NA) 14.42  (4.004) 13.67  (4.681) 11.08  (5.322)
Day 1; 1 hour; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
11.12 [1]   (NA) 13.14  (2.966) 7.53 [1]   (NA) 10.76  (2.228) 9.55  (4.437) 5.59  (2.709)
Day 1; 6 hours; n=1, 3, 1, 5, 4, 10 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 10 participants
9.88 [1]   (NA) 13.71  (2.679) 12.99 [1]   (NA) 11.69  (4.058) 9.39  (4.586) 5.35  (2.031)
Day 2; n=0, 0, 1, 1, 1, 2 Number Analyzed 0 participants 0 participants 1 participants 1 participants 1 participants 2 participants
8.12 [1]   (NA) 13.15 [1]   (NA) 4.59 [1]   (NA) 3.50  (2.001)
Day 8; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
10.14 [1]   (NA) 11.59  (4.353) 10.87 [1]   (NA) 10.85  (3.771) 6.32  (2.702) 6.05  (2.382)
Day 15; n=0, 2, 1, 3, 4, 10 Number Analyzed 0 participants 2 participants 1 participants 3 participants 4 participants 10 participants
10.62  (1.110) 7.37 [1]   (NA) 11.38  (3.535) 9.84  (3.127) 4.66  (1.402)
Day 29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
10.99 [1]   (NA) 12.18  (3.695) 7.69 [1]   (NA) 6.60  (3.220) 6.91  (4.621) 4.13  (1.815)
Follow-up; n=1, 2, 1, 3, 2, 5 Number Analyzed 1 participants 2 participants 1 participants 3 participants 2 participants 5 participants
6.19 [1]   (NA) 9.22  (3.090) 14.86 [1]   (NA) 5.41  (1.406) 3.73  (0.424) 4.39  (2.975)
[1]
Standard deviation could not be calculated as a single participant was analyzed at the specified time point.
17.Secondary Outcome
Title Overall Response Rate (ORR)-Parts 1 and 2
Hide Description ORR was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). ORR was calculated as the number of participants with best overall response of complete response (CR) and partial response (PR). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis and PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). An estimate to the true response rate for the number of participants analyzed is given. The 95% confidence interval was the exact confidence interval based on binomial proportion for ORR. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
0
(0.0 to 97.5)
0
(0.0 to 70.8)
0
(0.0 to 84.2)
0
(0.0 to 52.2)
0
(0.0 to 60.2)
1
(0.2 to 33.9)
18.Secondary Outcome
Title Number of Participants With Antibodies to GSK2849330 in Serum
Hide Description Serum samples were collected for the determination of anti-GSK2849330 antibodies using a validated immunoelectrochemiluminescent (ECL) assay. The assay involved screening, confirmation and titration steps (tiered-testing approach). If serum samples contained anti-GSK2849330 antibodies, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants who tested positive for anti-GSK2849330 antibody in confirmatory testing on Day 1 and at any time post-Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 2 5 4 14
Measure Type: Count of Participants
Unit of Measure: Participants
Day1; n=1, 3, 2, 5, 4, 13 Number Analyzed 1 participants 3 participants 2 participants 5 participants 4 participants 13 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
Any time post-Baseline; n=1, 3, 1, 5, 4, 7 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Percentage of Cluster of Differentiation (CD) Marker
Hide Description Blood samples were collected on Day (D) 1 at pre-dose (pre) and at 1 hour (h) and 6 h post infusion for the analysis of markers to evaluate biological activity of GSK2849330. A pre-dose blood sample was collected on D8, D15 and D29 with additional blood sample collected at progression of disease. CDX241 represent CD45+CD3-CD56+CD16+CD69+CD107+, CDX243=CD45+CD3-CD56+CD16+CD69+CD107-; CDX244=CD45+CD3-CD56+CD16+CD69-CD107+ and CDX245=CD45+CD3-CD56+CD16+CD69-CD107-. For participants in GSK2849330 3 mg/kg weekly arm, two samples (S1 and S2) were collected for D15 analysis. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.
Time Frame Median of 6.143 weeks of drug exposure
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK2849330 1.4 mg/kg Weekly GSK2849330 3 mg/kg Every 2 Weeks GSK2849330 3 mg/kg Weekly GSK2849330 10 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Every 2 Weeks GSK2849330 30 mg/kg Weekly
Hide Arm/Group Description:
Participants were administered a weekly dose of 1.4 mg/kg GSK2849330 as intravenous infusion for 28 days
Participants were administered 3 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered a weekly dose of 3 mg/kg GSK2849330 as intravenous infusion for 28 days.
Participants were administered 10 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days.
Participants were administered 30 mg/kg GSK2849330 as an intravenous infusion every 2 weeks for 28 days
Participants were administered a weekly dose of 30 mg/kg GSK2849330 as intravenous infusion for 28 days. The arm included participants receiving 30 mg/kg weekly from both Part 1 (dose-escalation cohort) and Part 2 (dose expansion cohort).
Overall Number of Participants Analyzed 1 3 1 5 4 12
Mean (Standard Deviation)
Unit of Measure: Percentage of CD marker cells
CD45+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
99.80 [1]   (NA) 99.83  (0.058) 99.90 [1]   (NA) 99.76  (0.434) 99.93  (0.050) 101.57  (6.268)
CD45+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
99.60 [1]   (NA) 99.87  (0.058) 99.80 [1]   (NA) 99.76  (0.434) 99.93  (0.050) 101.13  (4.656)
CD45+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
99.80 [1]   (NA) 99.83  (0.058) 99.90 [1]   (NA) 99.8  (0.255) 99.93  (0.096) 101.02  (3.978)
CD45+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
99.10 [1]   (NA) 99.7  (0.424) 99.80 [1]   (NA)
CD45+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
100.00 [1]   (NA) 99.87  (0.058) 99.4  (1.231) 99.80  (0.400) 99.75  (0.576)
CD45+; D15;S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
99.80 [1]   (NA) 99.90  (0.000) 99.9 [1]   (NA) 99.78  (0.327) 99.78  (0.320) 100.33  (2.495)
CD45+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
99.8 [1]   (NA)
CD45+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
99.90 [1]   (NA) 99.93  (0.058) 100.00 [1]   (NA) 99.78  (0.222) 99.75  (0.436) 100.80  (3.746)
CD45+; follow-up (FU); n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
100.00 [1]   (NA) 99.85  (0.071) 99.63  (0.551) 99.30 [1]   (NA) 101.60  (4.827)
CD45+; unscheduled (USC); n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
100.00 [1]   (NA)
CD45+CD3+; D1; pre;n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
62.70 [1]   (NA) 69.00  (13.313) 58.80 [1]   (NA) 86.88  (2.580) 71.98  (10.832) 72.91  (8.027)
CD45+CD3+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
76.20 [1]   (NA) 73.83  (9.646) 57.30 [1]   (NA) 87.08  (2.153) 75.80  (6.933) 74.36  (9.552)
CD45+CD3+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
81.20 [1]   (NA) 72.43  (12.784) 62.70 [1]   (NA) 86.88  (2.580) 77.83  (5.065) 72.16  (10.282)
CD45+CD3+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
48.40 [1]   (NA) 86.60  (0.566) 77.00 [1]   (NA)
CD45+CD3+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
72.30 [1]   (NA) 69.67  (17.310) 86.30  (1.505) 77.53  (7.566) 75.31  (8.234)
CD45+CD3+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
73.60 [1]   (NA) 68.97  (19.410) 36.8 [1]   (NA) 87.52  (1.359) 76.08  (8.844) 76.50  (5.723)
CD45+CD3+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
48.9 [1]   (NA)
CD45+CD3+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
76.70 [1]   (NA) 69.97  (17.609) 36.20 [1]   (NA) 87.30  (1.753) 73.58  (9.783) 74.49  (12.798)
CD45+CD3+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
64.50 [1]   (NA) 77.15  (7.425) 83.53  (7.966) 42.50 [1]   (NA) 70.13  (11.425)
CD45+CD3+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
58.70 [1]   (NA)
CD45+CD3+CD8+; D1; pre;n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
9.60 [1]   (NA) 21.67  (6.929) 21.60 [1]   (NA) 35.14  (22.721) 24.95  (13.644) 25.39  (11.076)
CD45+CD3+CD8+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
8.00 [1]   (NA) 20.20  (3.538) 20.50 [1]   (NA) 31.24  (21.617) 20.48  (10.935) 23.18  (10.434)
CD45+CD3+CD8+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
8.20 [1]   (NA) 17.47  (2.548) 23.20 [1]   (NA) 30.82  (22.379) 23.38  (11.738) 22.86  (11.701)
CD45+CD3+CD8+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
21.20 [1]   (NA) 19.70  (7.071) 40.60 [1]   (NA)
CD45+CD3+CD8+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
10.50 [1]   (NA) 22.70  (4.987) 35.24  (22.320) 24.60  (12.511) 23.76  (9.382)
CD45+CD3+CD8+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
9.70 [1]   (NA) 20.90  (6.843) 13 [1]   (NA) 36.46  (22.405) 26.25  (13.843) 27.00  (11.668)
CD45+CD3+CD8+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
15.7 [1]   (NA)
CD45+CD3+CD8+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
11.10 [1]   (NA) 20.93  (6.110) 17.10 [1]   (NA) 40.85  (23.034) 23.05  (11.997) 20.40  (13.234)
CD45+CD3+CD8+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
7.90 [1]   (NA) 24.55  (4.455) 45.10  (29.487) 6.30 [1]   (NA) 31.88  (4.661)
CD45+CD3+CD8+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
21.00 [1]   (NA)
CD45+CD3+CD8-; D1; pre n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
50.90 [1]   (NA) 45.90  (9.124) 36.20 [1]   (NA) 50.76  (20.204) 45.58  (4.365) 47.71  (14.059)
CD45+CD3+CD8-; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
66.60 [1]   (NA) 52.77  (8.732) 36.50 [1]   (NA) 54.92  (19.213) 53.90  (6.349) 51.10  (17.633)
CD45+CD3+CD8-; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
72.00 [1]   (NA) 54.10  (13.421) 36.40 [1]   (NA) 55.26  (19.752) 53.28  (10.943) 49.26  (17.654)
CD45+CD3+CD8-; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
26.90 [1]   (NA) 66.35  (7.425) 36.60 [1]   (NA)
CD45+CD3+CD8-; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
63.00 [1]   (NA) 46.80  (12.759) 50.48  (21.133) 51.70  (11.040) 51.48  (8.065)
CD45+CD3+CD8-; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
63.20 [1]   (NA) 48.37  (12.659) 24.3 [1]   (NA) 50.56  (21.357) 49.60  (9.910) 49.08  (13.029)
CD45+CD3+CD8-; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
36.1 [1]   (NA)
CD45+CD3+CD8-; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
65.40 [1]   (NA) 49.10  (12.137) 19.90 [1]   (NA) 45.55  (21.821) 50.43  (3.402) 54.63  (13.806)
CD45+CD3+CD8-; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
56.40 [1]   (NA) 52.50  (3.394) 38.20  (21.565) 36.90 [1]   (NA) 37.53  (16.020)
CD45+CD3+CD8-; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
38.30 [1]   (NA)
CD45+CD3-CD16+; D1; pre n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
24.3 [1]   (NA) 14.50  (7.375) 25.20 [1]   (NA) 4.96  (1.757) 13.83  (12.467) 10.63  (8.253)
CD45+CD3-CD16+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
9.40 [1]   (NA) 9.03  (5.972) 32.50 [1]   (NA) 4.44  (2.411) 8.00  (8.198) 8.90  (6.203)
CD45+CD3-CD16+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
3.10 [1]   (NA) 5.80  (6.538) 23.80 [1]   (NA) 3.30  (2.314) 6.43  (4.407) 7.44  (4.569)
CD45+CD3-CD16+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
35.30 [1]   (NA) 2.50  (0.566) 4.10 [1]   (NA)
CD45+CD3-CD16+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
11.30 [1]   (NA) 14.71  (12.293) 5.62  (3.128) 9.23  (5.762) 11.23  (7.852)
CD45+CD3-CD16+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
11.40 [1]   (NA) 13.73  (11.816) 47.7 [1]   (NA) 4.54  (3.138) 9.50  (6.470) 10.33  (7.555)
CD45+CD3-CD16+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
7.6 [1]   (NA)
CD45+CD3-CD16+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
11.30 [1]   (NA) 11.83  (9.530) 37.10 [1]   (NA) 5.75  (2.654) 10.73  (9.999) 11.93  (7.323)
CD45+CD3-CD16+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
20.80 [1]   (NA) 6.65  (4.031) 6.67  (2.237) 43.50 [1]   (NA) 10.03  (10.920)
CD45+CD3-CD16+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
19.50 [1]   (NA)
CD45+CD3-CD56+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
25.70 [1]   (NA) 14.03  (5.636) 25.80 [1]   (NA) 5.88  (1.221) 15.93  (11.588) 12.16  (7.479)
CD45+CD3-CD56+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
10.80 [1]   (NA) 10.13  (4.562) 32.80 [1]   (NA) 5.30  (1.581) 10.50  (7.470) 10.74  (6.300)
CD45+CD3-CD56+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
4.20 [1]   (NA) 7.47  (5.934) 26.60 [1]   (NA) 4.70  (1.913) 9.43  (3.079) 10.71  (7.319)
CD45+CD3-CD56+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
42.40 [1]   (NA) 4.10  (0.141) 5.60 [1]   (NA)
CD45+CD3-CD56+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
13.70 [1]   (NA) 14.43  (10.625) 6.16  (2.574) 11.10  (4.808) 12.33  (7.733)
CD45+CD3-CD56+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
13.50 [1]   (NA) 13.53  (11.288) 50.2 [1]   (NA) 5.96  (2.266) 11.73  (6.548) 8.39  (4.622)
CD45+CD3-CD56+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
8.7 [1]   (NA)
CD45+CD3-CD56+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
13.10 [1]   (NA) 11.90  (8.502) 42.30 [1]   (NA) 6.18  (2.428) 13.73  (9.582) 12.48  (9.517)
CD45+CD3-CD56+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
22.00 [1]   (NA) 7.80  (1.556) 8.37  (3.493) 44.20 [1]   (NA) 11.95  (8.912)
CD45+CD3-CD56+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
22.10 [1]   (NA)
CD45+CD3+CD56+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
3.30 [1]   (NA) 10.17  (8.905) 2.70 [1]   (NA) 13.18  (10.303) 6.20  (4.774) 4.67  (2.707)
CD45+CD3+CD56+; D1; 1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
1.80 [1]   (NA) 8.03  (8.410) 1.70 [1]   (NA) 10.70  (7.601) 6.65  (7.102) 4.20  (3.321)
CD45+CD3+CD56+; D1; 6 h; n=1, 3, 1, 5, 4, 11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
1.10 [1]   (NA) 6.87  (7.566) 13.80 [1]   (NA) 12.50  (11.924) 8.50  (10.745) 4.17  (3.299)
CD45+CD3+CD56+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
3.50 [1]   (NA) 20.90  (14.001) 7.00 [1]   (NA)
CD45+CD3+CD56+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
3.40 [1]   (NA) 10.23  (8.977) 12.36  (8.813) 5.83  (2.756) 3.49  (2.801)
CD45+CD3+CD56+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
2.20 [1]   (NA) 8.40  (8.118) 1.30 [1]   (NA) 13.48  (12.640) 8.15  (3.746) 4.43  (3.015)
CD45+CD3+CD56+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
1.3 [1]   (NA)
CD45+CD3+CD56+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
2.80 [1]   (NA) 9.33  (8.629) 3.80 [1]   (NA) 8.88  (5.197) 11.78  (9.751) 2.91  (2.635)
CD45+CD3+CD56+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
2.50 [1]   (NA) 16.20  (13.294) 16.07  (6.757) 3.50 [1]   (NA) 5.10  (2.665)
CD45+CD3+CD56+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
1.60 [1]   (NA)
CD45+CD3-CD16+CD56+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
23.40 [1]   (NA) 12.23  (6.307) 23.30 [1]   (NA) 4.48  (1.638) 13.25  (12.307) 9.58  (7.480)
CD45+CD3-CD16+CD56+; D1;1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
9.10 [1]   (NA) 8.10  (5.237) 31.10 [1]   (NA) 3.98  (2.244) 7.65  (8.118) 7.98  (5.768)
CD45+CD3-CD16+CD56+; D1;6 h; n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
3.00 [1]   (NA) 4.90  (5.403) 19.70 [1]   (NA) 2.92  (2.348) 6.10  (4.221) 6.22  (4.445)
CD45+CD3-CD16+CD56+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
33.60 [1]   (NA) 2.40  (0.566) 4.10 [1]   (NA)
CD45+CD3-CD16+CD56+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
10.80 [1]   (NA) 12.33  (10.979) 5.00  (2.891) 8.68  (5.465) 8.96  (6.217)
CD45+CD3-CD16+CD56+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
10.90 [1]   (NA) 11.93  (11.007) 43.5 [1]   (NA) 4.14  (2.926) 8.88  (6.357) 6.54  (4.360)
CD45+CD3-CD16+CD56+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
5.4 [1]   (NA)
CD45+CD3-CD16+CD56+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
10.80 [1]   (NA) 10.20  (8.542) 32.90 [1]   (NA) 5.05  (2.357) 10.18  (9.932) 9.30  (6.776)
CD45+CD3-CD16+CD56+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
19.30 [1]   (NA) 5.50  (3.111) 6.07  (2.566) 41.90 [1]   (NA) 9.20  (9.937)
CD45+CD3-CD16+CD56+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
18.30 [1]   (NA)
CD45+CD3-CD19+; D1; pre n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
9.10 [1]   (NA) 12.67  (4.936) 12.30 [1]   (NA) 5.36  (3.364) 9.48  (4.769) 8.39  (3.194)
CD45+CD3-CD19+; D1;1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
11.70 [1]   (NA) 13.77  (3.323) 8.30 [1]   (NA) 6.04  (3.492) 11.53  (6.211) 9.18  (3.819)
CD45+CD3-CD19+; D1;6 h; n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
11.30 [1]   (NA) 16.23  (3.329) 6.00 [1]   (NA) 6.36  (3.817) 10.83  (6.636) 9.00  (4.988)
CD45+CD3-CD19+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
6.40 [1]   (NA) 8.10  (0.141) 10.90 [1]   (NA)
CD45+CD3-CD19+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
10.70 [1]   (NA) 12.77  (4.701) 5.76  (3.895) 9.63  (4.786) 7.65  (4.176)
CD45+CD3-CD19+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
10.60 [1]   (NA) 14.03  (6.116) 7.9 [1]   (NA) 5.10  (3.180) 9.25  (4.339) 8.90  (4.170)
CD45+CD3-CD19+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
26.2 [1]   (NA)
CD45+CD3-CD19+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
8.90 [1]   (NA) 15.37  (7.392) 13.70 [1]   (NA) 5.10  (3.995) 10.53  (6.106) 7.44  (4.324)
CD45+CD3-CD19+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
10.00 [1]   (NA) 12.05  (4.313) 6.17  (8.361) 8.90 [1]   (NA) 8.33  (6.019)
CD45+CD3-CD19+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
15.90 [1]   (NA)
CD45+CD14+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
5.80 [1]   (NA) 4.87  (0.971) 10.40 [1]   (NA) 6.58  (1.293) 7.15  (2.029) 4.87  (1.406)
CD45+CD14+; D1;1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
1.40 [1]   (NA) 3.63  (2.103) 11.30 [1]   (NA) 5.20  (1.461) 4.68  (2.926) 3.52  (1.713)
CD45+CD14+; D1;6 h; n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
4.50 [1]   (NA) 5.37  (2.804) 11.80 [1]   (NA) 6.24  (1.756) 5.80  (2.389) 5.23  (2.581)
CD45+CD14+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
5.30 [1]   (NA) 5.10  (2.828) 4.40 [1]   (NA)
CD45+CD14+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
7.30 [1]   (NA) 6.30  (0.872) 6.60  (1.594) 7.10  (2.223) 5.40  (2.115)
CD45+CD14+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
4.70 [1]   (NA) 5.60  (1.652) 5.9 [1]   (NA) 6.66  (1.108) 6.93  (1.823) 5.47  (3.061)
CD45+CD14+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
18.9 [1]   (NA)
CD45+CD14+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
5.00 [1]   (NA) 4.93  (0.231) 7.60 [1]   (NA) 5.53  (1.162) 6.68  (2.241) 4.61  (1.108)
CD45+CD14+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
7.50 [1]   (NA) 5.50  (1.273) 8.03  (0.862) 2.70 [1]   (NA) 4.98  (1.692)
CD45+CD14+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
8.50 [1]   (NA)
CD45+CD3-CD16+CD69+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
67.92 [1]   (NA) 80.37  (3.710) 83.47 [1]   (NA) 80.92  (7.038) 82.50  (3.378) 75.71  (15.845)
CD45+CD3-CD16+CD69+; D1;1 h; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
76.94 [1]   (NA) 79.76  (2.213) 87.72 [1]   (NA) 81.88  (8.557) 86.01  (3.898) 78.53  (16.993)
CD45+CD3-CD16+CD69+; D1;6 h; n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
77.72 [1]   (NA) 76.99  (12.536) 90.79 [1]   (NA) 84.25  (5.802) 84.57  (4.448) 79.79  (12.178)
CD45+CD3-CD16+CD69+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
91.00 [1]   (NA) 89.03  (3.776) 88.05 [1]   (NA)
CD45+CD3-CD16+CD69+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
77.29 [1]   (NA) 75.83  (5.870) 81.34  (10.373) 79.91  (2.014) 70.93  (21.532)
CD45+CD3-CD16+CD69+; D15;S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
81.61 [1]   (NA) 79.04  (3.286) 96.49 [1]   (NA) 80.28  (6.867) 81.68  (7.216) 78.53  (20.178)
CD45+CD3-CD16+CD69+; D15;S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
92.76 [1]   (NA)
CD45+CD3-CD16+CD69+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
79.28 [1]   (NA) 81.92  (2.273) 85.01 [1]   (NA) 80.73  (6.688) 83.00  (6.240) 74.56  (17.788)
CD45+CD3-CD16+CD69+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
77.38 [1]   (NA) 84.40  (1.506) 81.52  (12.737) 76.46 [1]   (NA) 80.85  (19.555)
CD45+CD3-CD16+CD69+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
64.88 [1]   (NA)
CD45+CD3-CD16+CD107+; D1; pre; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
7.06 [1]   (NA) 13.40  (5.851) 18.18 [1]   (NA) 19.27  (13.221) 23.96  (12.309) 25.04  (30.481)
CD45+CD3-CD16+CD107+; D1;1 h; n=1, 3, 1, 5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
12.19 [1]   (NA) 15.18  (8.160) 8.77 [1]   (NA) 21.43  (13.416) 24.66  (13.827) 23.16  (24.866)
CD45+CD3-CD16+CD107+; D1;6 h; n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
14.85 [1]   (NA) 15.30  (6.477) 40.79 [1]   (NA) 32.01  (16.156) 21.55  (12.001) 21.82  (17.204)
CD45+CD3-CD16+CD107+; D2; n=0, 0, 1, 2, 0, 1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
26.00 [1]   (NA) 31.96  (9.454) 30.82 [1]   (NA)
CD45+CD3-CD16+CD107+; D8; n=1, 3, 0, 5, 4, 8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
33.73 [1]   (NA) 6.90  (3.044) 22.42  (10.572) 14.43  (1.615) 27.85  (27.884)
CD45+CD3-CD16+CD107+; D15; S1; n=1, 3, 1, 5, 4, 9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
17.29 [1]   (NA) 7.72  (4.937) 38.6 [1]   (NA) 17.00  (8.663) 18.30  (3.558) 21.68  (15.816)
CD45+CD3-CD16+CD107+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
65.89 [1]   (NA)
CD45+CD3-CD16+CD107+; D29; n=1, 3, 1, 4, 4, 8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
16.94 [1]   (NA) 8.78  (3.719) 52.86 [1]   (NA) 19.08  (4.869) 27.70  (12.686) 17.22  (6.799)
CD45+CD3-CD16+CD107+; FU; n=1, 2, 0, 3, 1, 4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
14.38 [1]   (NA) 22.49  (13.902) 31.28  (29.410) 11.64 [1]   (NA) 27.42  (15.633)
CD45+CD3-CD16+CD107+; USC; n=0, 0, 1, 0, 0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
16.51 [1]   (NA)
CD45+CD3-CD16+CD69+CD107+; D1; pre; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
6.86 [1]   (NA) 13.33  (5.869) 18.18 [1]   (NA) 19.05  (12.990) 23.53  (11.967) 24.68  (30.659)
CD45+CD3-CD16+CD69+CD107+; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
11.81 [1]   (NA) 14.86  (7.795) 8.77 [1]   (NA) 21.29  (13.208) 24.42  (13.709) 22.85  (24.965)
CD45+CD3-CD16+CD69+CD107+;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
14.85 [1]   (NA) 15.29  (6.364) 38.16 [1]   (NA) 31.96  (16.199) 21.33  (11.655) 21.34  (17.411)
CD45+CD3-CD16+CD69+CD107+; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
26.00 [1]   (NA) 31.42  (10.218) 30.19 [1]   (NA)
CD45+CD3-CD16+CD69+CD107+; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
32.80 [1]   (NA) 6.77  (3.013) 22.35  (10.534) 14.40  (1.591) 27.19  (27.949)
CD45+CD3-CD16+CD69+CD107+; D15; S1;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
16.92 [1]   (NA) 7.60  (4.890) 38.6 [1]   (NA) 16.94  (8.669) 18.11  (3.584) 21.11  (16.206)
CD45+CD3-CD16+CD69+CD107+; D15; S2;n=0,0,1,0,0, 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
64.8 [1]   (NA)
CD45+CD3-CD16+CD69+CD107+; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
16.42 [1]   (NA) 8.70  (3.598) 50.41 [1]   (NA) 18.76  (4.922) 27.36  (12.492) 16.08  (6.127)
CD45+CD3-CD16+CD69+CD107+; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
14.34 [1]   (NA) 22.24  (13.548) 31.06  (29.550) 11.56 [1]   (NA) 27.16  (15.866)
CD45+CD3-CD16+CD69+CD107+; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
15.77 [1]   (NA)
CD45+CD3-CD16+CD69+CD107-; D1;pre; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
61.07 [1]   (NA) 67.04  (7.996) 65.29 [1]   (NA) 61.87  (9.438) 58.97  (12.115) 51.03  (22.210)
CD45+CD3-CD16+CD69+CD107-; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
65.12 [1]   (NA) 64.90  (8.250) 78.95 [1]   (NA) 60.59  (8.489) 61.59  (10.979) 55.68  (18.837)
CD45+CD3-CD16+CD69+CD107-;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
62.87 [1]   (NA) 61.71  (10.282) 52.63 [1]   (NA) 52.29  (11.006) 63.25  (9.771) 58.44  (14.956)
CD45+CD3-CD16+CD69+CD107-; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
65.00 [1]   (NA) 57.62  (13.987) 57.86 [1]   (NA)
CD45+CD3-CD16+CD69+CD107-; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
44.49 [1]   (NA) 69.06  (8.555) 58.99  (8.379) 65.52  (2.097) 43.74  (17.564)
CD45+CD3-CD16+CD69+CD107-; D15;S1; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
64.68 [1]   (NA) 71.45  (1.611) 57.89 [1]   (NA) 63.34  (4.338) 63.57  (6.498) 57.42  (15.273)
CD45+CD3-CD16+CD69+CD107-; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
27.96 [1]   (NA)
CD45+CD3-CD16+CD69+CD107-; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
62.87 [1]   (NA) 73.22  (4.103) 34.60 [1]   (NA) 61.98  (6.511) 55.64  (6.702) 58.48  (19.691)
CD45+CD3-CD16+CD69+CD107-; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
63.04 [1]   (NA) 62.16  (15.047) 50.46  (18.585) 64.90 [1]   (NA) 53.69  (9.671)
CD45+CD3-CD16+CD69+CD107-; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
49.11 [1]   (NA)
CD45+CD3-CD16+CD69-CD107+; D1;pre n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
0.21 [1]   (NA) 0.07  (0.115) 0.00 [1]   (NA) 0.22  (0.265) 0.43  (0.395) 0.36  (0.740)
CD45+CD3-CD16+CD69-CD107+; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
0.38 [1]   (NA) 0.31  (0.399) 0.00 [1]   (NA) 0.14  (0.238) 0.24  (0.441) 0.32  (0.494)
CD45+CD3-CD16+CD69-CD107+;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
0.00 [1]   (NA) 0.09  (0.162) 2.63 [1]   (NA) 0.05  (0.069) 0.23  (0.403) 0.48  (1.014)
CD45+CD3-CD16+CD69-CD107+; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
0.00 [1]   (NA) 0.54  (0.764) 0.63 [1]   (NA)
CD45+CD3-CD16+CD69-CD107+; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
0.94 [1]   (NA) 0.14  (0.029) 0.07  (0.100) 0.04  (0.041) 0.66  (0.524)
CD45+CD3-CD16+CD69-CD107+; D15;S1; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
0.37 [1]   (NA) 0.12  (0.102) 0.00 [1]   (NA) 0.05  (0.121) 0.19  (0.236) 0.56  (0.890)
CD45+CD3-CD16+CD69-CD107+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
1.09 [1]   (NA)
CD45+CD3-CD16+CD69-CD107+; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
0.52 [1]   (NA) 0.07  (0.127) 2.45 [1]   (NA) 0.32  (0.326) 0.34  (0.241) 1.14  (1.844)
CD45+CD3-CD16+CD69-CD107+; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
0.03 [1]   (NA) 0.26  (0.361) 0.22  (0.333) 0.09 [1]   (NA) 0.27  (0.324)
CD45+CD3-CD16+CD69-CD107+; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
0.74 [1]   (NA)
CD45+CD3-CD16+CD69-CD107-; D1;pre; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
31.87 [1]   (NA) 19.57  (3.611) 16.53 [1]   (NA) 18.86  (7.256) 17.07  (3.528) 23.98  (15.442)
CD45+CD3-CD16+CD69-CD107-; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
22.68 [1]   (NA) 19.93  (2.396) 12.28 [1]   (NA) 17.98  (8.736) 13.75  (3.880) 21.36  (16.671)
CD45+CD3-CD16+CD69-CD107-;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
22.28 [1]   (NA) 22.91  (12.511) 6.58 [1]   (NA) 15.70  (5.783) 15.21  (4.603) 19.98  (11.842)
CD45+CD3-CD16+CD69-CD107-; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
9.00 [1]   (NA) 10.43  (4.540) 11.32 [1]   (NA)
CD45+CD3-CD16+CD69-CD107-; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
21.78 [1]   (NA) 24.03  (5.842) 18.63  (10.331) 20.05  (2.014) 28.47  (21.443)
CD45+CD3-CD16+CD69-CD107-; D15; S1;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
18.03 [1]   (NA) 20.84  (3.338) 3.51 [1]   (NA) 19.67  (6.810) 18.13  (7.060) 20.92  (19.349)
CD45+CD3-CD16+CD69-CD107-; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
6.15 [1]   (NA)
CD45+CD3-CD16+CD69-CD107-; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
20.20 [1]   (NA) 18.00  (2.247) 12.53 [1]   (NA) 18.97  (6.747) 16.67  (6.466) 24.35  (16.239)
CD45+CD3-CD16+CD69-CD107-; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
22.59 [1]   (NA) 15.35  (1.146) 18.34  (12.586) 23.54 [1]   (NA) 18.89  (19.247)
CD45+CD3-CD16+CD69-CD107-; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
34.38 [1]   (NA)
CD45+CD3-CD56+CD69+; D1;pre; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
67.22 [1]   (NA) 78.33  (3.952) 82.26 [1]   (NA) 77.55  (7.943) 77.94  (6.341) 71.81  (14.980)
CD45+CD3-CD56+CD69+; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
75.33 [1]   (NA) 77.13  (4.906) 86.96 [1]   (NA) 79.21  (8.936) 80.38  (5.074) 73.55  (18.249)
CD45+CD3-CD56+CD69+;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
79.56 [1]   (NA) 74.82  (11.935) 92.92 [1]   (NA) 80.05  (5.668) 79.33  (8.307) 74.28  (14.068)
CD45+CD3-CD56+CD69+; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
87.50 [1]   (NA) 84.69  (5.862) 84.79 [1]   (NA)
CD45+CD3-CD56+CD69+; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
75.33 [1]   (NA) 72.08  (3.948) 77.49  (9.757) 75.71  (6.039) 64.20  (17.380)
CD45+CD3-CD56+CD69+; D15;S1; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
80.07 [1]   (NA) 76.83  (2.746) 93.33 [1]   (NA) 76.69  (5.772) 77.05  (1.250) 74.14  (18.976)
CD45+CD3-CD56+CD69+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
90.79 [1]   (NA)
CD45+CD3-CD56+CD69+; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
76.99 [1]   (NA) 80.41  (3.445) 83.53 [1]   (NA) 77.90  (5.693) 78.39  (3.376) 72.21  (20.172)
CD45+CD3-CD56+CD69+; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
75.72 [1]   (NA) 83.15  (0.643) 78.85  (8.804) 76.62 [1]   (NA) 75.78  (15.172)
CD45+CD3-CD56+CD69+; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
64.59 [1]   (NA)
CD45+CD3-CD56+CD107+; D1; pre; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
2.47 [1]   (NA) 11.70  (5.812) 15.32 [1]   (NA) 16.30  (12.987) 20.36  (10.285) 15.35  (12.755)
CD45+CD3-CD56+CD107+; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
5.13 [1]   (NA) 13.87  (7.853) 6.69 [1]   (NA) 17.11  (11.990) 18.36  (8.295) 13.92  (14.620)
CD45+CD3-CD56+CD107+;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 11 participants
14.60 [1]   (NA) 16.66  (7.368) 31.76 [1]   (NA) 23.41  (13.644) 19.50  (10.930) 17.82  (13.218)
CD45+CD3-CD56+CD107+; D2; n=0,0,1,2,0,1 Number Analyzed 0 participants 0 participants 1 participants 2 participants 0 participants 1 participants
21.67 [1]   (NA) 28.04  (7.347) 26.27 [1]   (NA)
CD45+CD3-CD56+CD107+; D8; n=1,3,0,5,4,8 Number Analyzed 1 participants 3 participants 0 participants 5 participants 4 participants 8 participants
32.45 [1]   (NA) 6.79  (2.953) 17.46  (7.730) 12.81  (2.027) 15.17  (12.783)
CD45+CD3-CD56+CD107+; D15;S1; n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
15.54 [1]   (NA) 6.48  (3.558) 39.17 [1]   (NA) 14.18  (7.919) 13.95  (4.221) 16.02  (10.352)
CD45+CD3-CD56+CD107+; D15; S2; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
54.4 [1]   (NA)
CD45+CD3-CD56+CD107+; D29; n=1,3,1,4,4,8 Number Analyzed 1 participants 3 participants 1 participants 4 participants 4 participants 8 participants
15.85 [1]   (NA) 7.77  (3.841) 48.21 [1]   (NA) 15.09  (1.735) 22.89  (7.527) 17.13  (5.406)
CD45+CD3-CD56+CD107+; FU; n=1,2,0,3,1,4 Number Analyzed 1 participants 2 participants 0 participants 3 participants 1 participants 4 participants
13.08 [1]   (NA) 19.93  (11.469) 26.54  (22.053) 11.46 [1]   (NA) 23.63  (17.232)
CD45+CD3-CD56+CD107+; USC; n=0,0,1,0,0,0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
16.45 [1]   (NA)
CD45+CD3-CD56+CD69+CD107+; D1; pre n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
2.45 [1]   (NA) 11.58  (5.907) 15.32 [1]   (NA) 15.98  (12.746) 19.90  (9.878) 15.06  (12.804)
CD45+CD3-CD56+CD69+CD107+; D1;1 h;n=1,3,1,5,4,9 Number Analyzed 1 participants 3 participants 1 participants 5 participants 4 participants 9 participants
4.97 [1]   (NA) 13.56  (7.455) 6.96 [1]   (NA) 16.90  (11.974) 17.72  (8.423) 13.60  (14.641)
CD45+CD3-CD56+CD69+CD107+;D1;6 h;n=1,3,1,5,4,11 Number Analyzed 1 participants 3 participants