Trial Outcomes & Findings for Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698 (NCT NCT03044353)
NCT ID: NCT03044353
Last Updated: 2019-10-16
Results Overview
Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up
Results posted on
2019-10-16
Participant Flow
This was an open label, non-randomized, monthly repeat anti-serum amyloid p component (anti-SAP) treatment study in systemic amyloidosis participants with cardiac dysfunction caused by cardiac amyloidosis.
Twelve participants were screened; seven were enrolled in to study (six were enrolled in Group 1 and one in Group 2). No participant was enrolled in Group 3. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment).
Participant milestones
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants
Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants
Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
Baseline characteristics by cohort
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants
Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.3 Years
STANDARD_DEVIATION 3.27 • n=5 Participants
|
67.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
—
|
73.3 Years
STANDARD_DEVIATION 4.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian/European Heritage
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]).
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Session 2, Day 24, n=6,0
|
2.505 Grams
Standard Deviation 19.9174
|
—
|
|
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Session 3, Day 24, n=6,0
|
4.175 Grams
Standard Deviation 22.9366
|
—
|
|
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Session 4, Day 24, n=5,0
|
9.194 Grams
Standard Deviation 14.4271
|
—
|
|
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Session 5, Day 24, n=4,0
|
7.955 Grams
Standard Deviation 19.4341
|
—
|
|
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
8 Weeks Follow up, n=6,1
|
0.977 Grams
Standard Deviation 12.1795
|
-32.420 Grams
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
PRIMARY outcome
Timeframe: Up to 56 days after the last dosing session (up to 265 days)Population: Safety Population
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Any On-treatment Adverse Events (AEs)
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Any Serious Adverse Events (SAEs)
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormal Hematology Values
MCV, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Basophils, high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Basophils, normal
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Basophils, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Eosinophils, high
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Eosinophils, normal
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Eosinophils, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hematocrit, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hematocrit, normal
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hematocrit, low
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hemoglobin, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hemoglobin, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hemoglobin, low
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Lymphocytes, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Lymphocytes, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Lymphocytes, low
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCH, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCH, normal
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCH, low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCHC, high
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCHC, normal
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCHC, low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCV, normal
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCV, low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Monocytes, high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Monocytes, normal
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Monocytes, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Neutrophils, high
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Neutrophils, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Neutrophils, low
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Platelet count, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Platelet count, normal
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Platelet count, low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Erythrocytes, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Erythrocytes, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Erythrocytes, low
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Reticulocytes, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Reticulocytes, normal
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Reticulocytes, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Leukocytes, high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Values
Leukocytes, normal
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Leukocytes, low
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Values
Glucose, high
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Glucose, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Glucose, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Albumin, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Albumin, normal
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Albumin, low
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALP, high
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALP, normal
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALP, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALT, high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALT, normal
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALT, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
AST, high
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
AST, normal
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
AST, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Direct Bilirubin, high
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Direct Bilirubin, normal
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Direct Bilirubin, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Total Bilirubin, high
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Total Bilirubin, normal
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Total Bilirubin, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Calcium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Calcium, normal
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Calcium, low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine Kinase, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine Kinase, normal
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine Kinase, low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Chloride, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Chloride, normal
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Chloride, low
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
CO2, high
|
6 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
CO2, normal
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
CO2, low
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine, high
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine, normal
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Potassium, high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Potassium, normal
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Potassium, low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
LDH, high
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
LDH, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
LDH, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Protein, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Protein, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Protein, low
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Sodium, high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Sodium, normal
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Sodium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urate, high
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urate, normal
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urate, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urea, high
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urea, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urea, low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormal Urinalysis Results
pH, low, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Specific gravity, high, n=1,0
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Results
Specific gravity, normal, n=1,0
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Results
Specific gravity, low, n=1,0
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Results
Albumin excretion rate, high, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Albumin excretion rate, normal, n=6,1
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Albumin excretion rate, low, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Creatinine excretion rate, high, n=6,1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Creatinine excretion rate, normal, n=6,1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Creatinine excretion rate, low, n=6,1
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Protein excretion rate, high, n=6,1
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Protein excretion rate, normal, n=6,1
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
Protein excretion rate, low, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
pH, high, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results
pH, normal, n=6,1
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Cellular casts, n=5,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Erythrocytes , n=6,1
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Glucose, n=6,1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Ketones, n=6,1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Leukocytes, n=6,1
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Occult blood, n=6,1
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
To high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
To normal/No change
|
4 Participants
|
1 Participants
|
|
Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
To low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
SBP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
SBP, To normal/No change
|
1 Participants
|
1 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
SBP, To low
|
5 Participants
|
0 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
DBP, To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
DBP, To normal/No change
|
6 Participants
|
1 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
DBP, To low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
To high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
To normal/No change
|
6 Participants
|
1 Participants
|
|
Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
To low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal-Clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal-Not Clinically significant
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=5 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormalities During Cardiac Monitoring
Abnormal-Clinically significant
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities During Cardiac Monitoring
Abnormal-Not Clinically significant
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=2 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 56 days after the last dosing session (up to 265 days)Population: Safety Population
Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Skin Rashes
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 56 days after the last dosing session (up to 265 days)Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=4 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Skin Rashes Classified Using CTCAE
Grade 1
|
3 Participants
|
—
|
|
Number of Participants With Skin Rashes Classified Using CTCAE
Grade 2
|
1 Participants
|
—
|
|
Number of Participants With Skin Rashes Classified Using CTCAE
Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Skin Rashes Classified Using CTCAE
Grade 4
|
0 Participants
|
—
|
|
Number of Participants With Skin Rashes Classified Using CTCAE
Grade 5
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Skin biopsy samples were collected for histopathological examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population
Skin biopsy samples were collected for immunohistochemical examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Data was not collected due to project termination.
Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to the end of study (Up to 369 days)Population: Safety Population. Data was not collected due to project termination.
Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 1, 6 hour, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 1, 1 hour, n=4,0
|
-2.823 Nanograms per liter (ng/L)
Standard Deviation 4.3091
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 2, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 3, predose, n=4,0
|
-1.988 Nanograms per liter (ng/L)
Standard Deviation 5.0857
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 4, n=4,0
|
0.488 Nanograms per liter (ng/L)
Standard Deviation 0.9750
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 1, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 1, 1 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day -2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day -2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 3, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 1, 1 hour, n=6,1
|
4.887 Nanograms per liter (ng/L)
Standard Deviation 12.0436
|
0.450 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 1, 3 hour, n=6,1
|
1.097 Nanograms per liter (ng/L)
Standard Deviation 6.7834
|
0.480 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 2, n=6,1
|
10.977 Nanograms per liter (ng/L)
Standard Deviation 25.4607
|
12.720 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 3, predose, n=6,0
|
14.440 Nanograms per liter (ng/L)
Standard Deviation 13.4971
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 3, 3 hour, n=6,0
|
0.088 Nanograms per liter (ng/L)
Standard Deviation 4.3970
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 2, n=5,0
|
4.282 Nanograms per liter (ng/L)
Standard Deviation 8.9442
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 3, 6 hour, n=5,0
|
1.208 Nanograms per liter (ng/L)
Standard Deviation 3.6252
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 1, 3 hour, n=4,0
|
12.463 Nanograms per liter (ng/L)
Standard Deviation 16.7548
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 2, n=4,0
|
13.338 Nanograms per liter (ng/L)
Standard Deviation 15.7070
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 3, 6 hour, n=4,0
|
7.220 Nanograms per liter (ng/L)
Standard Deviation 9.8022
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 1, predose, n=4,0
|
-1.328 Nanograms per liter (ng/L)
Standard Deviation 2.1878
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 2, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 1, 1 hour, n=5,0
|
-1.240 Nanograms per liter (ng/L)
Standard Deviation 4.3736
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 1, 3 hour, n=5,0
|
-2.778 Nanograms per liter (ng/L)
Standard Deviation 3.9570
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 1, 6 hour, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 1, 1 hour, n=4,0
|
-1.423 Nanograms per liter (ng/L)
Standard Deviation 1.9828
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 1, 3 hour, n=4,0
|
-2.725 Nanograms per liter (ng/L)
Standard Deviation 2.8230
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 3, predose, n=5,0
|
-2.836 Nanograms per liter (ng/L)
Standard Deviation 2.6051
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 3, 1 hour, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 3, 3 hour, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 3, 6 hour, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 4, n=5,0
|
-3.274 Nanograms per liter (ng/L)
Standard Deviation 3.5110
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 5, n=4,0
|
-2.910 Nanograms per liter (ng/L)
Standard Deviation 3.1667
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 2, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 3, predose, n=4,0
|
0.753 Nanograms per liter (ng/L)
Standard Deviation 4.9155
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 3, 1 hour, n=4,0
|
0.203 Nanograms per liter (ng/L)
Standard Deviation 4.5195
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day -2, n=4,0
|
-0.930 Nanograms per liter (ng/L)
Standard Deviation 3.5480
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 3, 3 hour, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 3, 3 hour, n=4,0
|
-1.388 Nanograms per liter (ng/L)
Standard Deviation 4.8505
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 3, 6 hour, n=4,0
|
-2.838 Nanograms per liter (ng/L)
Standard Deviation 4.4804
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 4, n=4,0
|
-1.653 Nanograms per liter (ng/L)
Standard Deviation 6.0355
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 5, Day 5, n=4,0
|
-0.615 Nanograms per liter (ng/L)
Standard Deviation 2.9091
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day -2, n=4,0
|
-2.625 Nanograms per liter (ng/L)
Standard Deviation 4.4662
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 1, predose, n=4,0
|
-2.668 Nanograms per liter (ng/L)
Standard Deviation 4.4299
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 4, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 1, 3 hour, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 1, 6 hour, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 3, 1 hour, n=4,0
|
-3.018 Nanograms per liter (ng/L)
Standard Deviation 4.1848
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 1, 1 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 1, 3 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 1, 6 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 3, 6 hour, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 2, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 3, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 6, Day 5, n=4,0
|
-3.373 Nanograms per liter (ng/L)
Standard Deviation 4.0462
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day -2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 1, Day 1, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 3, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 2, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 1, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 1, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 1, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 1, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 3, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 5, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 1, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 1, 1 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 1, 3 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 1, 6 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 2, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 3, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 1, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day -2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 2, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 3, 1 hour, n=6,0
|
0.293 Nanograms per liter (ng/L)
Standard Deviation 0.7185
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 3, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 1, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 1, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 1, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 1, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 3, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 3, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 3, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 3, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 4, n=5,0
|
0.504 Nanograms per liter (ng/L)
Standard Deviation 1.1270
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 4, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 5, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-1 beta, Session 6, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 1, predose, n=6,1
|
0.275 Nanograms per liter (ng/L)
Standard Deviation 0.4711
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 1, 1 hour, n=6,1
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.7723
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 1, 3 hour, n=6,1
|
-0.727 Nanograms per liter (ng/L)
Standard Deviation 1.2035
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 1, 6 hour, n=6,1
|
-1.077 Nanograms per liter (ng/L)
Standard Deviation 1.2511
|
2.880 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 2, n=6,1
|
6.278 Nanograms per liter (ng/L)
Standard Deviation 6.3567
|
29.030 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 3, predose, n=6,1
|
7.688 Nanograms per liter (ng/L)
Standard Deviation 8.8639
|
16.980 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 3, 1 hour, n=6,0
|
6.857 Nanograms per liter (ng/L)
Standard Deviation 10.5934
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 3, 3 hour, n=6,0
|
0.827 Nanograms per liter (ng/L)
Standard Deviation 3.5790
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 3, 6 hour, n=6,0
|
0.932 Nanograms per liter (ng/L)
Standard Deviation 5.5637
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 4, n=6,0
|
5.453 Nanograms per liter (ng/L)
Standard Deviation 3.6039
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 1, Day 5, n=6,0
|
3.245 Nanograms per liter (ng/L)
Standard Deviation 3.3934
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day -2, n=6,0
|
0.393 Nanograms per liter (ng/L)
Standard Deviation 0.5250
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 1, predose, n=6,0
|
0.632 Nanograms per liter (ng/L)
Standard Deviation 1.2026
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 1, 1 hour, n=6,0
|
0.025 Nanograms per liter (ng/L)
Standard Deviation 0.7117
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 1, 3 hour, n=6,0
|
-0.860 Nanograms per liter (ng/L)
Standard Deviation 1.0909
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 1, 6 hour, n=6,0
|
-0.282 Nanograms per liter (ng/L)
Standard Deviation 1.7148
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 2, n=6,0
|
21.590 Nanograms per liter (ng/L)
Standard Deviation 27.1214
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 3, predose, n=6,0
|
11.365 Nanograms per liter (ng/L)
Standard Deviation 11.4140
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 3, 1 hour, n=6,0
|
7.517 Nanograms per liter (ng/L)
Standard Deviation 8.6084
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 3, 3 hour, n=6,0
|
3.460 Nanograms per liter (ng/L)
Standard Deviation 5.0176
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 3, 6 hour, n=6,0
|
0.723 Nanograms per liter (ng/L)
Standard Deviation 4.5392
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 4, n=6,0
|
4.580 Nanograms per liter (ng/L)
Standard Deviation 5.9326
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 2, Day 5, n=6,0
|
6.395 Nanograms per liter (ng/L)
Standard Deviation 5.2800
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day -2, n=5,0
|
0.148 Nanograms per liter (ng/L)
Standard Deviation 0.8211
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 1, predose, n=6,0
|
0.782 Nanograms per liter (ng/L)
Standard Deviation 1.5023
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 1, 1 hour, n=6,0
|
0.268 Nanograms per liter (ng/L)
Standard Deviation 1.4865
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 1, 3 hour, n=6,0
|
0.062 Nanograms per liter (ng/L)
Standard Deviation 2.5899
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 1, 6 hour, n=6,0
|
-0.918 Nanograms per liter (ng/L)
Standard Deviation 1.2591
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 2, n=5,0
|
17.608 Nanograms per liter (ng/L)
Standard Deviation 29.2558
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 3, predose, n=6,0
|
11.872 Nanograms per liter (ng/L)
Standard Deviation 8.7413
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 3, 1 hour, n=6,0
|
5.835 Nanograms per liter (ng/L)
Standard Deviation 3.8271
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 3, 3 hour, n=6,0
|
1.742 Nanograms per liter (ng/L)
Standard Deviation 1.9174
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 3, 6 hour, n=6,0
|
0.063 Nanograms per liter (ng/L)
Standard Deviation 2.2072
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 4, n=6,0
|
4.667 Nanograms per liter (ng/L)
Standard Deviation 6.9875
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 3, Day 5, n=6,0
|
5.570 Nanograms per liter (ng/L)
Standard Deviation 2.6004
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day -2, n=5,0
|
0.892 Nanograms per liter (ng/L)
Standard Deviation 0.8423
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 1, predose, n=5,0
|
1.486 Nanograms per liter (ng/L)
Standard Deviation 0.8702
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 1, 1 hour, n=5,0
|
0.926 Nanograms per liter (ng/L)
Standard Deviation 0.7103
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 1, 3 hour, n=5,0
|
-0.026 Nanograms per liter (ng/L)
Standard Deviation 0.1599
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 1, 6 hour, n=5,0
|
-1.028 Nanograms per liter (ng/L)
Standard Deviation 1.3685
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 2, n=5,0
|
5.720 Nanograms per liter (ng/L)
Standard Deviation 11.3851
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 3, predose, n=5,0
|
10.924 Nanograms per liter (ng/L)
Standard Deviation 6.5370
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 3, 1 hour, n=5,0
|
4.486 Nanograms per liter (ng/L)
Standard Deviation 2.0420
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 3, 3 hour, n=5,0
|
1.446 Nanograms per liter (ng/L)
Standard Deviation 1.5368
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 3, 6 hour, n=5,0
|
-0.116 Nanograms per liter (ng/L)
Standard Deviation 1.7948
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 4, n=5,0
|
5.756 Nanograms per liter (ng/L)
Standard Deviation 6.8645
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 4, Day 5, n=4,0
|
4.388 Nanograms per liter (ng/L)
Standard Deviation 3.7765
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day -2, n=4,0
|
0.027 Nanograms per liter (ng/L)
Standard Deviation 0.8164
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 1, predose, n=4,0
|
0.865 Nanograms per liter (ng/L)
Standard Deviation 0.9927
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 1, 1 hour, n=4,0
|
-0.007 Nanograms per liter (ng/L)
Standard Deviation 1.3219
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 1, 3 hour, n=4,0
|
-0.423 Nanograms per liter (ng/L)
Standard Deviation 1.5816
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 1, 6 hour, n=4,0
|
-1.213 Nanograms per liter (ng/L)
Standard Deviation 1.5189
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 2, n=4,0
|
0.905 Nanograms per liter (ng/L)
Standard Deviation 4.0920
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 3, predose, n=4,0
|
7.323 Nanograms per liter (ng/L)
Standard Deviation 4.8265
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 3, 1 hour, n=4,0
|
4.240 Nanograms per liter (ng/L)
Standard Deviation 3.6214
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 3, 3 hour, n=4,0
|
-0.125 Nanograms per liter (ng/L)
Standard Deviation 0.7543
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 3, 6 hour, n=4,0
|
-1.390 Nanograms per liter (ng/L)
Standard Deviation 1.3301
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 4, n=4,0
|
3.598 Nanograms per liter (ng/L)
Standard Deviation 5.7476
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 5, Day 5, n=4,0
|
6.533 Nanograms per liter (ng/L)
Standard Deviation 2.6812
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day -2, n=4,0
|
1.383 Nanograms per liter (ng/L)
Standard Deviation 1.8535
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 1, predose, n=4,0
|
0.565 Nanograms per liter (ng/L)
Standard Deviation 1.4007
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 1, 1 hour, n=4,0
|
0.077 Nanograms per liter (ng/L)
Standard Deviation 1.1200
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 1, 3 hour, n=4,0
|
-0.413 Nanograms per liter (ng/L)
Standard Deviation 1.4416
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 1, 6 hour, n=4,0
|
-1.165 Nanograms per liter (ng/L)
Standard Deviation 0.9786
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 2, n=4,0
|
0.932 Nanograms per liter (ng/L)
Standard Deviation 4.0340
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 3, predose, n=4,0
|
15.008 Nanograms per liter (ng/L)
Standard Deviation 13.0010
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 3, 1 hour, n=4,0
|
10.083 Nanograms per liter (ng/L)
Standard Deviation 9.2076
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 3, 3 hour, n=4,0
|
1.435 Nanograms per liter (ng/L)
Standard Deviation 1.7505
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 3, 6 hour, n=4,0
|
-1.005 Nanograms per liter (ng/L)
Standard Deviation 1.3522
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 4, n=4,0
|
1.740 Nanograms per liter (ng/L)
Standard Deviation 3.2649
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-6, Session 6, Day 5, n=4,0
|
7.190 Nanograms per liter (ng/L)
Standard Deviation 3.8811
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 1, predose, n=6,1
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 1, 1 hour, n=6,1
|
0.105 Nanograms per liter (ng/L)
Standard Deviation 0.1663
|
8.580 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 1, 3 hour, n=6,1
|
0.763 Nanograms per liter (ng/L)
Standard Deviation 0.4804
|
5.260 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 1, 6 hour, n=6,1
|
1.710 Nanograms per liter (ng/L)
Standard Deviation 1.4719
|
6.020 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 2, n=6,1
|
-0.005 Nanograms per liter (ng/L)
Standard Deviation 0.2436
|
1.150 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 3, predose, n=6,1
|
0.040 Nanograms per liter (ng/L)
Standard Deviation 0.3347
|
1.280 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 3, 1 hour, n=6,0
|
0.670 Nanograms per liter (ng/L)
Standard Deviation 1.0153
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 3, 3 hour, n=6,0
|
0.065 Nanograms per liter (ng/L)
Standard Deviation 0.3896
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 3, 6 hour, n=6,0
|
0.002 Nanograms per liter (ng/L)
Standard Deviation 0.0041
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 1, Day 4, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day -2, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 1, predose, n=6,0
|
0.002 Nanograms per liter (ng/L)
Standard Deviation 0.0041
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 1, 1 hour, n=6,0
|
0.612 Nanograms per liter (ng/L)
Standard Deviation 0.8293
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 1, 3 hour, n=6,0
|
1.132 Nanograms per liter (ng/L)
Standard Deviation 1.1748
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 1, 6 hour, n=6,0
|
0.785 Nanograms per liter (ng/L)
Standard Deviation 0.5189
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 2, n=6,0
|
0.012 Nanograms per liter (ng/L)
Standard Deviation 0.2757
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 3, predose, n=6,0
|
0.233 Nanograms per liter (ng/L)
Standard Deviation 0.5618
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 3, 1 hour, n=6,0
|
0.775 Nanograms per liter (ng/L)
Standard Deviation 1.1274
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 3, 3 hour, n=6,0
|
0.782 Nanograms per liter (ng/L)
Standard Deviation 0.8451
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 3, 6 hour, n=6,0
|
0.015 Nanograms per liter (ng/L)
Standard Deviation 0.0367
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 4, n=6,0
|
-0.005 Nanograms per liter (ng/L)
Standard Deviation 0.0122
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 2, Day 5, n=6,0
|
0.110 Nanograms per liter (ng/L)
Standard Deviation 0.2122
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day -2, n=5,0
|
0.032 Nanograms per liter (ng/L)
Standard Deviation 0.3422
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 1, predose, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 1, 1 hour, n=6,0
|
0.228 Nanograms per liter (ng/L)
Standard Deviation 0.2328
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 1, 3 hour, n=6,0
|
1.185 Nanograms per liter (ng/L)
Standard Deviation 1.1559
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 1, 6 hour, n=6,0
|
0.495 Nanograms per liter (ng/L)
Standard Deviation 0.6641
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 2, n=5,0
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.1789
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 3, predose, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 3, 1 hour, n=6,0
|
0.450 Nanograms per liter (ng/L)
Standard Deviation 0.6048
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 3, 3 hour, n=6,0
|
0.322 Nanograms per liter (ng/L)
Standard Deviation 0.5322
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 3, 6 hour, n=6,0
|
0.092 Nanograms per liter (ng/L)
Standard Deviation 0.1542
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 4, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 3, Day 5, n=6,0
|
-0.067 Nanograms per liter (ng/L)
Standard Deviation 0.1633
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day -2, n=5,0
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.1789
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 1, predose, n=5,0
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.1789
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 1, 1 hour, n=5,0
|
0.758 Nanograms per liter (ng/L)
Standard Deviation 1.4466
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 1, 3 hour, n=5,0
|
3.868 Nanograms per liter (ng/L)
Standard Deviation 6.3123
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 1, 6 hour, n=5,0
|
0.868 Nanograms per liter (ng/L)
Standard Deviation 0.9281
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 2, n=5,0
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.1789
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 3, predose, n=5,0
|
0.022 Nanograms per liter (ng/L)
Standard Deviation 0.0492
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 3, 1 hour, n=5,0
|
0.808 Nanograms per liter (ng/L)
Standard Deviation 1.0592
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 3, 3 hour, n=5,0
|
0.598 Nanograms per liter (ng/L)
Standard Deviation 0.6549
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 3, 6 hour, n=5,0
|
0.184 Nanograms per liter (ng/L)
Standard Deviation 0.4284
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 4, n=5,0
|
-0.080 Nanograms per liter (ng/L)
Standard Deviation 0.1789
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 4, Day 5, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day -2, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 1, predose, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 1, 1 hour, n=4,0
|
2.485 Nanograms per liter (ng/L)
Standard Deviation 4.8507
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 1, 3 hour, n=4,0
|
3.828 Nanograms per liter (ng/L)
Standard Deviation 6.5828
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 1, 6 hour, n=4,0
|
1.120 Nanograms per liter (ng/L)
Standard Deviation 1.5607
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 2, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 3, predose, n=4,0
|
0.393 Nanograms per liter (ng/L)
Standard Deviation 0.4774
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 3, 1 hour, n=4,0
|
0.950 Nanograms per liter (ng/L)
Standard Deviation 0.9330
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 3, 3 hour, n=4,0
|
1.060 Nanograms per liter (ng/L)
Standard Deviation 0.9783
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 3, 6 hour, n=4,0
|
0.663 Nanograms per liter (ng/L)
Standard Deviation 0.6663
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 4, n=4,0
|
0.210 Nanograms per liter (ng/L)
Standard Deviation 0.4267
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 5, Day 5, n=4,0
|
0.025 Nanograms per liter (ng/L)
Standard Deviation 0.0500
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day -2, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 1, predose, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 1, 1 hour, n=4,0
|
0.333 Nanograms per liter (ng/L)
Standard Deviation 0.9506
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 1, 3 hour, n=4,0
|
1.738 Nanograms per liter (ng/L)
Standard Deviation 2.5365
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 1, 6 hour, n=4,0
|
1.418 Nanograms per liter (ng/L)
Standard Deviation 1.7245
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 2, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 3, predose, n=4,0
|
0.015 Nanograms per liter (ng/L)
Standard Deviation 0.0300
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 3, 1 hour, n=4,0
|
0.753 Nanograms per liter (ng/L)
Standard Deviation 1.4004
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 3, 3 hour, n=4,0
|
0.675 Nanograms per liter (ng/L)
Standard Deviation 1.1466
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 3, 6 hour, n=4,0
|
0.220 Nanograms per liter (ng/L)
Standard Deviation 0.2723
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 4, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 0.2000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-10, Session 6, Day 5, n=4,0
|
0.023 Nanograms per liter (ng/L)
Standard Deviation 0.0450
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 1, predose, n=6,1
|
0.055 Nanograms per liter (ng/L)
Standard Deviation 0.4378
|
0.320 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 1, 1 hour, n=6,1
|
0.007 Nanograms per liter (ng/L)
Standard Deviation 0.7159
|
0.100 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 1, 3 hour, n=6,1
|
-0.180 Nanograms per liter (ng/L)
Standard Deviation 0.7430
|
0.880 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 1, 6 hour, n=6,1
|
-0.132 Nanograms per liter (ng/L)
Standard Deviation 0.8145
|
2.300 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 2, n=6,1
|
1.920 Nanograms per liter (ng/L)
Standard Deviation 1.5379
|
5.130 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 3, predose, n=6,1
|
1.453 Nanograms per liter (ng/L)
Standard Deviation 1.3405
|
3.010 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 3, 1 hour, n=6,0
|
1.240 Nanograms per liter (ng/L)
Standard Deviation 0.9968
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 3, 3 hour, n=6,0
|
0.797 Nanograms per liter (ng/L)
Standard Deviation 1.0229
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 3, 6 hour, n=6,0
|
0.460 Nanograms per liter (ng/L)
Standard Deviation 0.9373
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 4, n=6,0
|
1.088 Nanograms per liter (ng/L)
Standard Deviation 1.2874
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 1, Day 5, n=6,0
|
1.577 Nanograms per liter (ng/L)
Standard Deviation 1.5915
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day -2, n=6,0
|
0.167 Nanograms per liter (ng/L)
Standard Deviation 0.9735
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 1, predose, n=6,0
|
0.233 Nanograms per liter (ng/L)
Standard Deviation 0.8351
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 1, 1 hour, n=6,0
|
0.133 Nanograms per liter (ng/L)
Standard Deviation 1.0259
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 1, 3 hour, n=6,0
|
0.015 Nanograms per liter (ng/L)
Standard Deviation 1.0940
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 1, 6 hour, n=6,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 1.2625
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 2, n=6,0
|
1.523 Nanograms per liter (ng/L)
Standard Deviation 1.6646
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 3, predose, n=6,0
|
2.143 Nanograms per liter (ng/L)
Standard Deviation 1.5642
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 3, 1 hour, n=6,0
|
1.682 Nanograms per liter (ng/L)
Standard Deviation 1.3855
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 3, 3 hour, n=6,0
|
1.133 Nanograms per liter (ng/L)
Standard Deviation 0.9970
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 3, 6 hour, n=6,0
|
0.503 Nanograms per liter (ng/L)
Standard Deviation 1.0718
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 4, n=6,0
|
1.397 Nanograms per liter (ng/L)
Standard Deviation 2.1712
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 2, Day 5, n=6,0
|
1.968 Nanograms per liter (ng/L)
Standard Deviation 1.4560
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day -2, n=5,0
|
0.098 Nanograms per liter (ng/L)
Standard Deviation 1.2163
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 1, predose, n=6,0
|
0.497 Nanograms per liter (ng/L)
Standard Deviation 0.9650
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 1, 1 hour, n=6,0
|
-0.297 Nanograms per liter (ng/L)
Standard Deviation 0.9572
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 1, 3 hour, n=6,0
|
-0.198 Nanograms per liter (ng/L)
Standard Deviation 0.9246
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 1, 6 hour, n=6,0
|
-0.167 Nanograms per liter (ng/L)
Standard Deviation 1.2317
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 2, n=5,0
|
0.446 Nanograms per liter (ng/L)
Standard Deviation 1.1212
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 3, predose, n=6,0
|
1.267 Nanograms per liter (ng/L)
Standard Deviation 1.1583
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 3, 1 hour, n=6,0
|
0.513 Nanograms per liter (ng/L)
Standard Deviation 1.1234
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 3, 3 hour, n=6,0
|
0.128 Nanograms per liter (ng/L)
Standard Deviation 1.0706
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 3, 6 hour, n=6,0
|
0.233 Nanograms per liter (ng/L)
Standard Deviation 1.2605
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 4, n=6,0
|
0.585 Nanograms per liter (ng/L)
Standard Deviation 1.6017
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 3, Day 5, n=6,0
|
0.997 Nanograms per liter (ng/L)
Standard Deviation 1.3819
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day -2, n=5,0
|
-0.208 Nanograms per liter (ng/L)
Standard Deviation 0.5949
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 1, predose, n=5,0
|
-0.214 Nanograms per liter (ng/L)
Standard Deviation 0.8527
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 1, 1 hour, n=5,0
|
0.160 Nanograms per liter (ng/L)
Standard Deviation 1.5494
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 1, 3 hour, n=5,0
|
0.218 Nanograms per liter (ng/L)
Standard Deviation 1.5011
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 1, 6 hour, n=5,0
|
-0.412 Nanograms per liter (ng/L)
Standard Deviation 1.1373
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 2, n=5,0
|
-0.122 Nanograms per liter (ng/L)
Standard Deviation 0.6977
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 3, predose, n=5,0
|
0.606 Nanograms per liter (ng/L)
Standard Deviation 0.5265
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 3, 1 hour, n=5,0
|
0.100 Nanograms per liter (ng/L)
Standard Deviation 0.5074
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 3, 3 hour, n=5,0
|
0.098 Nanograms per liter (ng/L)
Standard Deviation 0.7172
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 3, 6 hour, n=5,0
|
-0.702 Nanograms per liter (ng/L)
Standard Deviation 0.5368
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 4, n=5,0
|
-0.270 Nanograms per liter (ng/L)
Standard Deviation 0.7576
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 4, Day 5, n=4,0
|
0.095 Nanograms per liter (ng/L)
Standard Deviation 0.4456
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day -2, n=4,0
|
-0.350 Nanograms per liter (ng/L)
Standard Deviation 0.5814
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 1, predose, n=4,0
|
-0.320 Nanograms per liter (ng/L)
Standard Deviation 0.6703
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 1, 1 hour, n=4,0
|
-0.130 Nanograms per liter (ng/L)
Standard Deviation 1.2227
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 1, 3 hour, n=4,0
|
-0.055 Nanograms per liter (ng/L)
Standard Deviation 1.0728
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 1, 6 hour, n=4,0
|
-0.513 Nanograms per liter (ng/L)
Standard Deviation 1.1003
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 2, n=4,0
|
-0.498 Nanograms per liter (ng/L)
Standard Deviation 0.9752
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 3, predose, n=4,0
|
0.147 Nanograms per liter (ng/L)
Standard Deviation 0.8951
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 3, 1 hour, n=4,0
|
-0.188 Nanograms per liter (ng/L)
Standard Deviation 0.7406
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 3, 3 hour, n=4,0
|
-0.378 Nanograms per liter (ng/L)
Standard Deviation 0.9306
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 3, 6 hour, n=4,0
|
-0.630 Nanograms per liter (ng/L)
Standard Deviation 0.7857
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 4, n=4,0
|
-0.100 Nanograms per liter (ng/L)
Standard Deviation 1.0725
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 5, Day 5, n=4,0
|
0.168 Nanograms per liter (ng/L)
Standard Deviation 0.3909
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day -2, n=4,0
|
-0.428 Nanograms per liter (ng/L)
Standard Deviation 1.3664
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 1, predose, n=4,0
|
-0.238 Nanograms per liter (ng/L)
Standard Deviation 1.3158
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 1, 1 hour, n=4,0
|
-0.303 Nanograms per liter (ng/L)
Standard Deviation 1.3853
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 1, 3 hour, n=4,0
|
-0.145 Nanograms per liter (ng/L)
Standard Deviation 1.8684
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 1, 6 hour, n=4,0
|
-0.500 Nanograms per liter (ng/L)
Standard Deviation 1.4020
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 2, n=4,0
|
-0.000 Nanograms per liter (ng/L)
Standard Deviation 1.3253
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 3, predose, n=4,0
|
0.278 Nanograms per liter (ng/L)
Standard Deviation 1.9987
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 3, 1 hour, n=4,0
|
-0.195 Nanograms per liter (ng/L)
Standard Deviation 1.6007
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 3, 3 hour, n=4,0
|
-0.385 Nanograms per liter (ng/L)
Standard Deviation 1.4669
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 3, 6 hour, n=4,0
|
-0.585 Nanograms per liter (ng/L)
Standard Deviation 1.3026
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 4, n=4,0
|
-0.368 Nanograms per liter (ng/L)
Standard Deviation 1.1280
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
TNF, Session 6, Day 5, n=4,0
|
0.322 Nanograms per liter (ng/L)
Standard Deviation 1.2795
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 1, predose, n=6,1
|
0.075 Nanograms per liter (ng/L)
Standard Deviation 1.6224
|
1.860 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 1, 1 hour, n=6,1
|
-1.373 Nanograms per liter (ng/L)
Standard Deviation 2.1255
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 1, 3 hour, n=6,1
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 1, 6 hour, n=6,1
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 2, n=6,1
|
1.713 Nanograms per liter (ng/L)
Standard Deviation 7.5955
|
1.930 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 3, predose, n=6,1
|
17.122 Nanograms per liter (ng/L)
Standard Deviation 27.3980
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 3, 1 hour, n=6,0
|
12.118 Nanograms per liter (ng/L)
Standard Deviation 22.0807
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 3, 3 hour, n=6,0
|
7.150 Nanograms per liter (ng/L)
Standard Deviation 18.4949
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 3, 6 hour, n=6,0
|
0.538 Nanograms per liter (ng/L)
Standard Deviation 8.5114
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 4, n=6,0
|
3.242 Nanograms per liter (ng/L)
Standard Deviation 12.2847
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 1, Day 5, n=6,0
|
19.502 Nanograms per liter (ng/L)
Standard Deviation 38.3215
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day -2, n=6,0
|
-1.045 Nanograms per liter (ng/L)
Standard Deviation 3.4175
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 1, predose, n=6,0
|
0.452 Nanograms per liter (ng/L)
Standard Deviation 3.5018
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 1, 1 hour, n=6,0
|
0.145 Nanograms per liter (ng/L)
Standard Deviation 3.2180
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 1, 3 hour, n=6,0
|
-1.833 Nanograms per liter (ng/L)
Standard Deviation 1.3991
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 1, 6 hour, n=6,0
|
-3.072 Nanograms per liter (ng/L)
Standard Deviation 2.6378
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 2, n=6,0
|
-2.660 Nanograms per liter (ng/L)
Standard Deviation 3.5043
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 3, predose, n=6,0
|
-1.045 Nanograms per liter (ng/L)
Standard Deviation 2.2260
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 3, 1 hour, n=6,0
|
-1.580 Nanograms per liter (ng/L)
Standard Deviation 2.5672
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 3, 3 hour, n=6,0
|
-2.473 Nanograms per liter (ng/L)
Standard Deviation 2.5631
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 3, 6 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 4, n=6,0
|
-2.572 Nanograms per liter (ng/L)
Standard Deviation 3.4040
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 2, Day 5, n=6,0
|
-1.993 Nanograms per liter (ng/L)
Standard Deviation 2.8977
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day -2, n=5,0
|
-2.190 Nanograms per liter (ng/L)
Standard Deviation 3.9839
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 1, predose, n=6,0
|
-1.035 Nanograms per liter (ng/L)
Standard Deviation 4.4739
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 1, 1 hour, n=6,0
|
-2.180 Nanograms per liter (ng/L)
Standard Deviation 3.8365
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 1, 3 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 1, 6 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 2, n=5,0
|
-2.936 Nanograms per liter (ng/L)
Standard Deviation 3.7855
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 3, predose, n=6,0
|
-2.948 Nanograms per liter (ng/L)
Standard Deviation 2.3737
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 3, 1 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 3, 3 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 3, 6 hour, n=6,0
|
-3.298 Nanograms per liter (ng/L)
Standard Deviation 3.1409
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 4, n=6,0
|
-3.048 Nanograms per liter (ng/L)
Standard Deviation 3.1886
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 3, Day 5, n=6,0
|
-2.752 Nanograms per liter (ng/L)
Standard Deviation 3.2989
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day -2, n=5,0
|
0.298 Nanograms per liter (ng/L)
Standard Deviation 5.3631
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
INF gamma, Session 4, Day 1, predose, n=5,0
|
-0.760 Nanograms per liter (ng/L)
Standard Deviation 4.2290
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 3, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 3, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 3, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 4, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 4, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 6, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 1, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 1, 1 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 1, 3 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 1, 6 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 2, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 3, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 1, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day -2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 2, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 3, predose, n=6,0
|
0.333 Nanograms per liter (ng/L)
Standard Deviation 0.8165
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 3, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 1, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 1, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 1, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 1, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 3, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 3, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 3, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 3, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 4, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 4, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 3, 1 hour, n=4,0
|
0.283 Nanograms per liter (ng/L)
Standard Deviation 0.5650
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 5, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-12, Session 5, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 3, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-13, Session 6, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 3, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 1, 3 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 1, 6 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 2, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 3, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 3, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 4, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 3, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 1, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 5, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 1, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 2, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 6, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 1, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 1, 1 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 1, 3 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 1, 6 hour, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 1, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 1, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 1, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 3, predose, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 3, 1 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 3, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 3, 6 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 4, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 6, Day 5, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 1, predose, n=6,1
|
4.377 Nanograms per liter (ng/L)
Standard Deviation 5.8881
|
1.140 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 1, 6 hour, n=6,1
|
4.400 Nanograms per liter (ng/L)
Standard Deviation 9.5000
|
8.350 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 3, predose, n=6,1
|
6.830 Nanograms per liter (ng/L)
Standard Deviation 10.6309
|
9.350 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 3, 1 hour, n=6,0
|
3.035 Nanograms per liter (ng/L)
Standard Deviation 6.9193
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 3, 3 hour, n=6,0
|
-0.788 Nanograms per liter (ng/L)
Standard Deviation 4.9840
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 3, 6 hour, n=6,0
|
-0.490 Nanograms per liter (ng/L)
Standard Deviation 7.3654
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 4, n=6,0
|
-0.542 Nanograms per liter (ng/L)
Standard Deviation 5.0480
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 1, Day 5, n=6,0
|
1.198 Nanograms per liter (ng/L)
Standard Deviation 3.0063
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day -2, n=6,0
|
7.848 Nanograms per liter (ng/L)
Standard Deviation 12.9271
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 1, predose, n=6,0
|
4.920 Nanograms per liter (ng/L)
Standard Deviation 8.3853
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 1, 1 hour, n=6,0
|
1.592 Nanograms per liter (ng/L)
Standard Deviation 6.9965
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 1, 3 hour, n=6,0
|
0.275 Nanograms per liter (ng/L)
Standard Deviation 7.2669
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 1, 6 hour, n=6,0
|
1.243 Nanograms per liter (ng/L)
Standard Deviation 6.1976
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 2, n=6,0
|
5.468 Nanograms per liter (ng/L)
Standard Deviation 7.5652
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 3, predose, n=6,0
|
8.322 Nanograms per liter (ng/L)
Standard Deviation 5.0082
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 3, 1 hour, n=6,0
|
6.432 Nanograms per liter (ng/L)
Standard Deviation 10.6402
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 3, 3 hour, n=6,0
|
-1.107 Nanograms per liter (ng/L)
Standard Deviation 5.8160
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 3, 6 hour, n=6,0
|
-0.870 Nanograms per liter (ng/L)
Standard Deviation 4.6278
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 4, n=6,0
|
1.667 Nanograms per liter (ng/L)
Standard Deviation 5.5170
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 2, Day 5, n=6,0
|
2.853 Nanograms per liter (ng/L)
Standard Deviation 5.4769
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day -2, n=5,0
|
12.742 Nanograms per liter (ng/L)
Standard Deviation 7.8571
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 1, predose, n=6,0
|
7.635 Nanograms per liter (ng/L)
Standard Deviation 6.3602
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 1, 1 hour, n=6,0
|
3.848 Nanograms per liter (ng/L)
Standard Deviation 5.5264
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 1, 3 hour, n=6,0
|
-0.517 Nanograms per liter (ng/L)
Standard Deviation 5.6983
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 1, 6 hour, n=6,0
|
0.933 Nanograms per liter (ng/L)
Standard Deviation 8.0166
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 2, n=5,0
|
3.024 Nanograms per liter (ng/L)
Standard Deviation 5.5819
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 3, 1 hour, n=6,0
|
4.887 Nanograms per liter (ng/L)
Standard Deviation 5.2130
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 3, 6 hour, n=6,0
|
2.450 Nanograms per liter (ng/L)
Standard Deviation 6.2029
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 4, n=6,0
|
3.680 Nanograms per liter (ng/L)
Standard Deviation 4.5662
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 3, Day 5, n=6,0
|
7.783 Nanograms per liter (ng/L)
Standard Deviation 3.9382
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day -2, n=5,0
|
15.686 Nanograms per liter (ng/L)
Standard Deviation 10.4436
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 1, predose, n=5,0
|
9.910 Nanograms per liter (ng/L)
Standard Deviation 11.2178
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 1, 1 hour, n=5,0
|
10.088 Nanograms per liter (ng/L)
Standard Deviation 13.7154
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 1, 3 hour, n=5,0
|
5.242 Nanograms per liter (ng/L)
Standard Deviation 11.1547
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 1, 6 hour, n=5,0
|
6.992 Nanograms per liter (ng/L)
Standard Deviation 12.0857
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 3, predose, n=5,0
|
15.072 Nanograms per liter (ng/L)
Standard Deviation 11.8360
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 3, 1 hour, n=5,0
|
10.536 Nanograms per liter (ng/L)
Standard Deviation 8.8924
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 3, 3 hour, n=5,0
|
1.474 Nanograms per liter (ng/L)
Standard Deviation 3.3523
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 4, n=5,0
|
7.118 Nanograms per liter (ng/L)
Standard Deviation 14.6164
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 4, Day 5, n=4,0
|
-1.795 Nanograms per liter (ng/L)
Standard Deviation 4.8526
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day -2, n=4,0
|
21.055 Nanograms per liter (ng/L)
Standard Deviation 14.5161
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 1, predose, n=4,0
|
18.213 Nanograms per liter (ng/L)
Standard Deviation 16.0292
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 1, 1 hour, n=4,0
|
17.667 Nanograms per liter (ng/L)
Standard Deviation 15.2020
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 1, 6 hour, n=4,0
|
5.617 Nanograms per liter (ng/L)
Standard Deviation 8.7263
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 2, n=4,0
|
5.463 Nanograms per liter (ng/L)
Standard Deviation 9.5943
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 3, predose, n=4,0
|
16.915 Nanograms per liter (ng/L)
Standard Deviation 13.4207
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 3, 1 hour, n=4,0
|
9.240 Nanograms per liter (ng/L)
Standard Deviation 11.0353
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 3, 3 hour, n=4,0
|
5.902 Nanograms per liter (ng/L)
Standard Deviation 9.1992
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 3, 6 hour, n=4,0
|
5.335 Nanograms per liter (ng/L)
Standard Deviation 7.4134
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 4, n=4,0
|
7.610 Nanograms per liter (ng/L)
Standard Deviation 12.4139
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 5, Day 5, n=4,0
|
7.330 Nanograms per liter (ng/L)
Standard Deviation 14.2059
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day -2, n=4,0
|
12.908 Nanograms per liter (ng/L)
Standard Deviation 11.2540
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 1, predose, n=4,0
|
17.575 Nanograms per liter (ng/L)
Standard Deviation 14.9713
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 1, 1 hour, n=4,0
|
18.718 Nanograms per liter (ng/L)
Standard Deviation 14.2024
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 1, 3 hour, n=4,0
|
13.823 Nanograms per liter (ng/L)
Standard Deviation 18.3486
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 1, 6 hour, n=4,0
|
12.923 Nanograms per liter (ng/L)
Standard Deviation 15.0125
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 3, predose, n=4,0
|
25.338 Nanograms per liter (ng/L)
Standard Deviation 17.9965
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 3, 1 hour, n=4,0
|
11.733 Nanograms per liter (ng/L)
Standard Deviation 12.1142
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 3, 3 hour, n=4,0
|
6.853 Nanograms per liter (ng/L)
Standard Deviation 7.9858
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 4, n=4,0
|
13.500 Nanograms per liter (ng/L)
Standard Deviation 13.0942
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-8, Session 6, Day 5, n=4,0
|
14.130 Nanograms per liter (ng/L)
Standard Deviation 9.1046
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 3, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 1, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 1, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 1, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 1, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-2, Session 4, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 2, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 3, predose, n=6,1
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
0.000 Nanograms per liter (ng/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 1, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 2, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 2, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 1, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 1, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 1, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 3, predose, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 3, 1 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 3, 3 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 3, 6 hour, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 4, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 3, Day 5, n=6,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day -2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 1, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 1, 1 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 1, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 1, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 2, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 3, predose, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 3, 3 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 3, 6 hour, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 4, Day 4, n=5,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day -2, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
|
Change From Baseline in Plasma Cytokines Over Time
IL-4, Session 5, Day 1, 3 hour, n=4,0
|
0.000 Nanograms per liter (ng/L)
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 6, n=6,0
|
-0.338 Grams per Liter (g/L)
Standard Deviation 0.1969
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 1, predose, n=6,0
|
-0.067 Grams per Liter (g/L)
Standard Deviation 0.1999
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 1, 4 hour, n=6,1
|
0.030 Grams per Liter (g/L)
Standard Deviation 0.0566
|
-0.100 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 1, 8 hour, n=6,1
|
0.068 Grams per Liter (g/L)
Standard Deviation 0.2073
|
-0.160 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 1, 8 hour, n=6,0
|
-0.130 Grams per Liter (g/L)
Standard Deviation 0.1585
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 2, n=6,0
|
-0.153 Grams per Liter (g/L)
Standard Deviation 0.1485
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 3, predose, n=6,0
|
-0.263 Grams per Liter (g/L)
Standard Deviation 0.1385
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 3, 2 hour, n=6,0
|
-0.242 Grams per Liter (g/L)
Standard Deviation 0.1694
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 3, 4 hour, n=6,0
|
-0.243 Grams per Liter (g/L)
Standard Deviation 0.1994
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 1, predose, n=6,0
|
-0.053 Grams per Liter (g/L)
Standard Deviation 0.1928
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 1, 2 hour, n=6,0
|
-0.078 Grams per Liter (g/L)
Standard Deviation 0.2279
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 3, predose, n=6,0
|
-0.215 Grams per Liter (g/L)
Standard Deviation 0.1576
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 3, 2 hour, n=6,0
|
-0.232 Grams per Liter (g/L)
Standard Deviation 0.1699
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 3, predose, n=5,0
|
-0.214 Grams per Liter (g/L)
Standard Deviation 0.2454
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 1, 4 hour, n=4,0
|
-0.125 Grams per Liter (g/L)
Standard Deviation 0.1741
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 3, predose, n=4,0
|
-0.248 Grams per Liter (g/L)
Standard Deviation 0.1919
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 5, n=4,0
|
-0.258 Grams per Liter (g/L)
Standard Deviation 0.2035
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 6, n=4,0
|
-0.288 Grams per Liter (g/L)
Standard Deviation 0.1941
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 5, n=4,0
|
-0.288 Grams per Liter (g/L)
Standard Deviation 0.2269
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 6, n=4,0
|
-0.315 Grams per Liter (g/L)
Standard Deviation 0.2225
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 1, predose, n=6,1
|
-0.032 Grams per Liter (g/L)
Standard Deviation 0.1444
|
-0.150 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 1, 2 hour, n=6,1
|
-0.008 Grams per Liter (g/L)
Standard Deviation 0.1105
|
-0.230 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 2, n=6,1
|
-0.125 Grams per Liter (g/L)
Standard Deviation 0.1033
|
-0.180 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 3, predose, n=6,1
|
-0.198 Grams per Liter (g/L)
Standard Deviation 0.1607
|
-0.200 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 3, 2 hour, n=6,0
|
-0.188 Grams per Liter (g/L)
Standard Deviation 0.1572
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 3, 4 hour, n=6,0
|
-0.222 Grams per Liter (g/L)
Standard Deviation 0.1288
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 3, 8 hour, n=6,0
|
-0.155 Grams per Liter (g/L)
Standard Deviation 0.1590
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 1, Day 5, n=6,0
|
-0.280 Grams per Liter (g/L)
Standard Deviation 0.1646
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 1, 2 hour, n=6,0
|
-0.103 Grams per Liter (g/L)
Standard Deviation 0.1629
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 1, 4 hour, n=6,0
|
-0.075 Grams per Liter (g/L)
Standard Deviation 0.2017
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 3, 8 hour, n=6,0
|
-0.235 Grams per Liter (g/L)
Standard Deviation 0.1685
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 5, n=6,0
|
-0.280 Grams per Liter (g/L)
Standard Deviation 0.1716
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 2, Day 6, n=6,0
|
-0.327 Grams per Liter (g/L)
Standard Deviation 0.2298
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 1, 4 hour, n=6,0
|
-0.058 Grams per Liter (g/L)
Standard Deviation 0.2299
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 1, 8 hour, n=6,0
|
-0.057 Grams per Liter (g/L)
Standard Deviation 0.1999
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 2, n=5,0
|
-0.084 Grams per Liter (g/L)
Standard Deviation 0.2792
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 3, 4 hour, n=6,0
|
-0.200 Grams per Liter (g/L)
Standard Deviation 0.1808
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 3, 8 hour, n=6,0
|
-0.190 Grams per Liter (g/L)
Standard Deviation 0.2287
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 5, n=6,0
|
-0.290 Grams per Liter (g/L)
Standard Deviation 0.1719
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 3, Day 6, n=6,0
|
-0.308 Grams per Liter (g/L)
Standard Deviation 0.2077
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 1, predose, n=5,0
|
-0.094 Grams per Liter (g/L)
Standard Deviation 0.2271
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 1, 2 hour, n=5,0
|
-0.088 Grams per Liter (g/L)
Standard Deviation 0.1993
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 1, 4 hour, n=4,0
|
-0.005 Grams per Liter (g/L)
Standard Deviation 0.1392
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 1, 8 hour, n=5,0
|
-0.124 Grams per Liter (g/L)
Standard Deviation 0.1747
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 2, n=5,0
|
-0.144 Grams per Liter (g/L)
Standard Deviation 0.1641
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 3, 2 hour, n=5,0
|
-0.204 Grams per Liter (g/L)
Standard Deviation 0.2306
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 3, 4 hour, n=5,0
|
-0.190 Grams per Liter (g/L)
Standard Deviation 0.2088
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 3, 8 hour, n=5,0
|
-0.188 Grams per Liter (g/L)
Standard Deviation 0.2305
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 5, n=5,0
|
-0.270 Grams per Liter (g/L)
Standard Deviation 0.1996
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 4, Day 6, n=5,0
|
-0.302 Grams per Liter (g/L)
Standard Deviation 0.2251
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 1, predose, n=4,0
|
-0.173 Grams per Liter (g/L)
Standard Deviation 0.1863
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 1, 2 hour, n=4,0
|
-0.147 Grams per Liter (g/L)
Standard Deviation 0.2326
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 1, 8 hour, n=4,0
|
-0.150 Grams per Liter (g/L)
Standard Deviation 0.1881
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 2, n=4,0
|
-0.178 Grams per Liter (g/L)
Standard Deviation 0.2340
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 3, 2 hour, n=4,0
|
-0.235 Grams per Liter (g/L)
Standard Deviation 0.1964
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 3, 4 hour, n=4,0
|
-0.280 Grams per Liter (g/L)
Standard Deviation 0.2045
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 5, Day 3, 8 hour, n=4,0
|
-0.235 Grams per Liter (g/L)
Standard Deviation 0.2301
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 1, predose, n=4,0
|
-0.152 Grams per Liter (g/L)
Standard Deviation 0.2144
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 1, 2 hour, n=4,0
|
-0.145 Grams per Liter (g/L)
Standard Deviation 0.1877
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 1, 4 hour, n=4,0
|
-0.145 Grams per Liter (g/L)
Standard Deviation 0.2528
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 1, 8 hour, n=4,0
|
-0.135 Grams per Liter (g/L)
Standard Deviation 0.2626
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 2, n=4,0
|
-0.203 Grams per Liter (g/L)
Standard Deviation 0.2090
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 3, predose, n=4,0
|
-0.215 Grams per Liter (g/L)
Standard Deviation 0.2319
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 3, 2 hour, n=4,0
|
-0.273 Grams per Liter (g/L)
Standard Deviation 0.2179
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 3, 4 hour, n=4,0
|
-0.235 Grams per Liter (g/L)
Standard Deviation 0.2243
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
C3, Session 6, Day 3, 8 hour, n=4,0
|
-0.238 Grams per Liter (g/L)
Standard Deviation 0.2421
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 2, Day 5, Day 6Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 1, Day 2, n=6,1
|
-0.015 Grams per Liter (g/L)
Standard Deviation 0.0373
|
0.000 Grams per Liter (g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 1, Day 5, n=6,0
|
-0.013 Grams per Liter (g/L)
Standard Deviation 0.0393
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 2, Day 5, n=6,0
|
-0.023 Grams per Liter (g/L)
Standard Deviation 0.0505
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 4, Day 2, n=5,0
|
-0.022 Grams per Liter (g/L)
Standard Deviation 0.0531
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 1, Day 6, n=6,0
|
-0.017 Grams per Liter (g/L)
Standard Deviation 0.0403
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 2, Day 2, n=6,0
|
-0.027 Grams per Liter (g/L)
Standard Deviation 0.0423
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 2, Day 6, n=6,0
|
-0.030 Grams per Liter (g/L)
Standard Deviation 0.0540
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 3, Day 2, n=5,0
|
-0.010 Grams per Liter (g/L)
Standard Deviation 0.0543
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 3, Day 5, n=6,0
|
-0.042 Grams per Liter (g/L)
Standard Deviation 0.0449
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 3, Day 6, n=6,0
|
-0.042 Grams per Liter (g/L)
Standard Deviation 0.0542
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 4, Day 5, n=5,0
|
-0.036 Grams per Liter (g/L)
Standard Deviation 0.0677
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 4, Day 6, n=5,0
|
-0.042 Grams per Liter (g/L)
Standard Deviation 0.0507
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 5, Day 2, n=4,0
|
-0.028 Grams per Liter (g/L)
Standard Deviation 0.0574
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 5, Day 5, n=4,0
|
-0.033 Grams per Liter (g/L)
Standard Deviation 0.0574
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 5, Day 6, n=4,0
|
-0.025 Grams per Liter (g/L)
Standard Deviation 0.0545
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 6, Day 2, n=4,0
|
-0.043 Grams per Liter (g/L)
Standard Deviation 0.0544
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 6, Day 5, n=4,0
|
-0.050 Grams per Liter (g/L)
Standard Deviation 0.0678
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
C4, Session 6, Day 6, n=4,0
|
-0.045 Grams per Liter (g/L)
Standard Deviation 0.0666
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 1, predose, n=6,1
|
-0.7 Units per milliliter
Standard Deviation 1.37
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 1, 2 hour, n=6,0
|
-4.2 Units per milliliter
Standard Deviation 7.44
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 2, n=5,0
|
-3.6 Units per milliliter
Standard Deviation 8.68
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 3, 2 hour, n=6,0
|
-5.2 Units per milliliter
Standard Deviation 8.86
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 5, n=6,0
|
-7.0 Units per milliliter
Standard Deviation 10.28
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 1, 8 hour, n=5,0
|
-1.6 Units per milliliter
Standard Deviation 3.21
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 3, predose, n=5,0
|
-5.0 Units per milliliter
Standard Deviation 6.08
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 1, 2 hour, n=4,0
|
-3.0 Units per milliliter
Standard Deviation 5.72
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 1, 4 hour, n=4,0
|
-2.8 Units per milliliter
Standard Deviation 6.29
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 2, n=4,0
|
-3.5 Units per milliliter
Standard Deviation 5.32
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 3, 2 hour, n=4,0
|
-4.8 Units per milliliter
Standard Deviation 6.80
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 3, 4 hour, n=4,0
|
-4.8 Units per milliliter
Standard Deviation 6.70
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 1, predose, n=4,0
|
-2.3 Units per milliliter
Standard Deviation 4.03
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 1, 2 hour, n=4,0
|
-2.8 Units per milliliter
Standard Deviation 6.90
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 3, 4 hour, n=4,0
|
-4.3 Units per milliliter
Standard Deviation 8.66
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 3, 8 hour, n=4,0
|
-5.0 Units per milliliter
Standard Deviation 8.52
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 5, n=4,0
|
-5.3 Units per milliliter
Standard Deviation 9.00
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 1, 2 hour, n=6,1
|
-0.8 Units per milliliter
Standard Deviation 1.33
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 1, 4 hour, n=6,1
|
0.2 Units per milliliter
Standard Deviation 0.41
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 1, 8 hour, n=6,1
|
-0.8 Units per milliliter
Standard Deviation 1.60
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 2, n=6,1
|
-2.7 Units per milliliter
Standard Deviation 3.20
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 3, predose, n=6,1
|
-3.3 Units per milliliter
Standard Deviation 4.46
|
0.0 Units per milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 3, 2 hour, n=6,0
|
-3.3 Units per milliliter
Standard Deviation 4.37
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 3, 4 hour, n=6,0
|
-2.5 Units per milliliter
Standard Deviation 3.78
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 3, 8 hour, n=6,0
|
-2.2 Units per milliliter
Standard Deviation 3.25
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 5, n=6,0
|
-4.7 Units per milliliter
Standard Deviation 5.01
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 1, Day 6, n=6,0
|
-7.3 Units per milliliter
Standard Deviation 6.19
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 1, predose, n=6,0
|
-1.7 Units per milliliter
Standard Deviation 3.67
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 1, 2 hour, n=6,0
|
-2.3 Units per milliliter
Standard Deviation 4.84
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 1, 4 hour, n=6,0
|
-2.3 Units per milliliter
Standard Deviation 4.63
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 1, 8 hour, n=6,0
|
-3.5 Units per milliliter
Standard Deviation 7.84
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 2, n=6,0
|
-4.3 Units per milliliter
Standard Deviation 6.02
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 3, predose, n=6,0
|
-4.5 Units per milliliter
Standard Deviation 6.16
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 3, 2 hour, n=6,0
|
-4.0 Units per milliliter
Standard Deviation 5.55
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 3, 4 hour, n=6,0
|
-3.8 Units per milliliter
Standard Deviation 6.31
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 3, 8 hour, n=6,0
|
-3.8 Units per milliliter
Standard Deviation 3.92
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 5, n=6,0
|
-5.2 Units per milliliter
Standard Deviation 6.31
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 2, Day 6, n=6,0
|
-8.5 Units per milliliter
Standard Deviation 9.61
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 1, predose, n=6,0
|
-4.5 Units per milliliter
Standard Deviation 7.94
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 1, 4 hour, n=6,0
|
-4.5 Units per milliliter
Standard Deviation 7.79
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 1, 8 hour, n=6,0
|
-4.8 Units per milliliter
Standard Deviation 8.35
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 3, predose, n=6,0
|
-5.2 Units per milliliter
Standard Deviation 8.86
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 3, 4 hour, n=6,0
|
-5.3 Units per milliliter
Standard Deviation 8.57
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 3, 8 hour, n=6,0
|
-6.8 Units per milliliter
Standard Deviation 10.05
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 3, Day 6, n=6,0
|
-8.2 Units per milliliter
Standard Deviation 11.02
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 1, predose, n=5,0
|
-3.0 Units per milliliter
Standard Deviation 5.20
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 1, 2 hour, n=5,0
|
-2.0 Units per milliliter
Standard Deviation 3.94
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 1, 4 hour, n=5,0
|
-1.6 Units per milliliter
Standard Deviation 4.77
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 2, n=5,0
|
-1.6 Units per milliliter
Standard Deviation 3.13
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 3, 2 hour, n=5,0
|
-3.2 Units per milliliter
Standard Deviation 4.09
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 3, 4 hour, n=5,0
|
-3.0 Units per milliliter
Standard Deviation 6.40
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 3, 8 hour, n=5,0
|
-4.0 Units per milliliter
Standard Deviation 6.04
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 5, n=5,0
|
-5.6 Units per milliliter
Standard Deviation 7.70
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 4, Day 6, n=5,0
|
-6.6 Units per milliliter
Standard Deviation 7.83
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 1, predose, n=4,0
|
-3.8 Units per milliliter
Standard Deviation 5.91
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 1, 8 hour, n=4,0
|
-3.0 Units per milliliter
Standard Deviation 5.29
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 3, predose, n=4,0
|
-5.0 Units per milliliter
Standard Deviation 5.77
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 3, 8 hour, n=4,0
|
-4.8 Units per milliliter
Standard Deviation 6.80
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 5, n=4,0
|
-5.5 Units per milliliter
Standard Deviation 7.72
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 5, Day 6, n=4,0
|
-5.3 Units per milliliter
Standard Deviation 8.54
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 1, 4 hour, n=4,0
|
-3.3 Units per milliliter
Standard Deviation 7.27
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 1, 8 hour, n=4,0
|
-3.5 Units per milliliter
Standard Deviation 6.66
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 2, n=4,0
|
-4.3 Units per milliliter
Standard Deviation 6.13
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 3, predose, n=4,0
|
-5.0 Units per milliliter
Standard Deviation 8.52
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 3, 2 hour, n=4,0
|
-4.8 Units per milliliter
Standard Deviation 8.54
|
—
|
|
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
CH50, Session 6, Day 6, n=4,0
|
-5.5 Units per milliliter
Standard Deviation 9.47
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 2, n=5,1
|
0.64 Milligrams per Liter (mg/L)
Standard Deviation 1.701
|
44.70 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 2, n=4,0
|
1.75 Milligrams per Liter (mg/L)
Standard Deviation 2.161
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 3, 2 hour, n=4,0
|
19.40 Milligrams per Liter (mg/L)
Standard Deviation 16.403
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 3, 8 hour, n=4,0
|
22.63 Milligrams per Liter (mg/L)
Standard Deviation 18.466
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 1, 8 hour, n=4,0
|
2.40 Milligrams per Liter (mg/L)
Standard Deviation 4.455
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 2, n=4,0
|
2.23 Milligrams per Liter (mg/L)
Standard Deviation 3.963
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 1, 8 hour, n=3,0
|
2.10 Milligrams per Liter (mg/L)
Standard Deviation 3.378
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 2, n=3,0
|
1.37 Milligrams per Liter (mg/L)
Standard Deviation 2.811
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 1, 8 hour, n=3,0
|
3.70 Milligrams per Liter (mg/L)
Standard Deviation 3.874
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 2, n=3,0
|
2.63 Milligrams per Liter (mg/L)
Standard Deviation 2.914
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 3, 8 hour, n=3,0
|
14.67 Milligrams per Liter (mg/L)
Standard Deviation 12.580
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 1, 4 hour, n=4,1
|
-0.20 Milligrams per Liter (mg/L)
Standard Deviation 0.271
|
-3.70 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 1, 8 hour, n=5,1
|
-0.10 Milligrams per Liter (mg/L)
Standard Deviation 0.406
|
-3.60 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 2, n=5,1
|
0.56 Milligrams per Liter (mg/L)
Standard Deviation 1.286
|
41.40 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 3, 4 hour, n=5,0
|
15.84 Milligrams per Liter (mg/L)
Standard Deviation 13.607
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 3, 8 hour, n=5,0
|
31.10 Milligrams per Liter (mg/L)
Standard Deviation 26.885
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 1, predose, n=3,0
|
2.03 Milligrams per Liter (mg/L)
Standard Deviation 3.349
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 1, 2 hour, n=3,0
|
1.97 Milligrams per Liter (mg/L)
Standard Deviation 3.320
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 5, n=3,0
|
14.43 Milligrams per Liter (mg/L)
Standard Deviation 7.801
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 6, n=3,0
|
18.63 Milligrams per Liter (mg/L)
Standard Deviation 8.607
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 1, 2 hour, n=5,1
|
0.1738 Milligrams per Liter (mg/L)
Standard Deviation 1.13909
|
-22.4187 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 1, 4 hour, n=5,1
|
0.3902 Milligrams per Liter (mg/L)
Standard Deviation 1.56253
|
-21.7463 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 2, n=5,1
|
2.9247 Milligrams per Liter (mg/L)
Standard Deviation 3.47577
|
322.2895 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 3, 2 hour, n=5,0
|
54.8466 Milligrams per Liter (mg/L)
Standard Deviation 59.36005
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 3, 4 hour, n=5,0
|
54.9329 Milligrams per Liter (mg/L)
Standard Deviation 55.92645
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 3, predose, n=5,0
|
134.4489 Milligrams per Liter (mg/L)
Standard Deviation 160.14208
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 5, n=5,0
|
76.8593 Milligrams per Liter (mg/L)
Standard Deviation 136.83379
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 1, predose, n=4,0
|
0.2428 Milligrams per Liter (mg/L)
Standard Deviation 1.13002
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 3, predose, n=4,0
|
45.1067 Milligrams per Liter (mg/L)
Standard Deviation 82.67535
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 2, n=3,0
|
0.1380 Milligrams per Liter (mg/L)
Standard Deviation 0.61958
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 3, predose, n=3,0
|
10.8884 Milligrams per Liter (mg/L)
Standard Deviation 17.72052
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 1, 4 hour, n=3,0
|
3.50 Milligrams per Liter (mg/L)
Standard Deviation 3.799
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 1, 2 hour, n=4,0
|
0.1863 Milligrams per Liter (mg/L)
Standard Deviation 1.06333
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 1, 4 hour, n=4,0
|
0.0475 Milligrams per Liter (mg/L)
Standard Deviation 1.00422
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 1, 8 hour, n=5,0
|
4.0339 Milligrams per Liter (mg/L)
Standard Deviation 8.62955
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 2, n=4,0
|
6.4822 Milligrams per Liter (mg/L)
Standard Deviation 11.14119
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 3, predose, n=5,0
|
54.7393 Milligrams per Liter (mg/L)
Standard Deviation 82.22346
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 3, 2 hour, n=5,0
|
58.0526 Milligrams per Liter (mg/L)
Standard Deviation 83.12677
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 3, 4 hour, n=5,0
|
64.1995 Milligrams per Liter (mg/L)
Standard Deviation 93.61736
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 3, 8 hour, n=5,0
|
66.9605 Milligrams per Liter (mg/L)
Standard Deviation 93.98658
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 5, n=5,0
|
58.6742 Milligrams per Liter (mg/L)
Standard Deviation 50.93398
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 3, Day 6, n=5,0
|
49.4029 Milligrams per Liter (mg/L)
Standard Deviation 46.30012
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 1, 8 hour, n=3,0
|
3.27 Milligrams per Liter (mg/L)
Standard Deviation 3.584
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 1, predose, n=4,0
|
-0.1305 Milligrams per Liter (mg/L)
Standard Deviation 1.86822
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 1, 2 hour, n=4,0
|
0.0159 Milligrams per Liter (mg/L)
Standard Deviation 1.91086
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 1, 4 hour, n=4,0
|
-0.0013 Milligrams per Liter (mg/L)
Standard Deviation 1.84104
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 1, 8 hour, n=4,0
|
0.1997 Milligrams per Liter (mg/L)
Standard Deviation 1.70496
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 2, n=4,0
|
1.6015 Milligrams per Liter (mg/L)
Standard Deviation 1.07082
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 3, 2 hour, n=4,0
|
51.0650 Milligrams per Liter (mg/L)
Standard Deviation 94.33211
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 3, 4 hour, n=4,0
|
55.0009 Milligrams per Liter (mg/L)
Standard Deviation 101.37965
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 3, 8 hour, n=4,0
|
55.7135 Milligrams per Liter (mg/L)
Standard Deviation 101.39069
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 5, n=4,0
|
51.2002 Milligrams per Liter (mg/L)
Standard Deviation 54.84780
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 4, Day 6, n=4,0
|
41.2457 Milligrams per Liter (mg/L)
Standard Deviation 38.77052
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 1, predose, n=3,0
|
-0.1498 Milligrams per Liter (mg/L)
Standard Deviation 1.04561
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 1, 2 hour, n=3,0
|
-0.2399 Milligrams per Liter (mg/L)
Standard Deviation 0.89843
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 1, 4 hour, n=3,0
|
-0.1906 Milligrams per Liter (mg/L)
Standard Deviation 0.94124
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 1, 8 hour, n=3,0
|
-0.1771 Milligrams per Liter (mg/L)
Standard Deviation 0.95814
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 3, 2 hour, n=3,0
|
8.6783 Milligrams per Liter (mg/L)
Standard Deviation 11.48176
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 3, 4 hour, n=3,0
|
9.2527 Milligrams per Liter (mg/L)
Standard Deviation 11.23663
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 2, n=3,0
|
2.33 Milligrams per Liter (mg/L)
Standard Deviation 2.775
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 3, 8 hour, n=3,0
|
13.7941 Milligrams per Liter (mg/L)
Standard Deviation 19.39827
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 3, predose, n=3,0
|
8.97 Milligrams per Liter (mg/L)
Standard Deviation 9.752
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 5, n=3,0
|
66.2542 Milligrams per Liter (mg/L)
Standard Deviation 107.98594
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 5, Day 6, n=3,0
|
73.0823 Milligrams per Liter (mg/L)
Standard Deviation 118.07036
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 1, predose, n=3,0
|
1.2964 Milligrams per Liter (mg/L)
Standard Deviation 1.75482
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 1, 2 hour, n=3,0
|
1.0538 Milligrams per Liter (mg/L)
Standard Deviation 1.74392
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 1, 4 hour, n=3,0
|
1.3139 Milligrams per Liter (mg/L)
Standard Deviation 2.18542
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 1, 8 hour, n=3,0
|
0.9078 Milligrams per Liter (mg/L)
Standard Deviation 1.72500
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 2, n=3,0
|
1.2641 Milligrams per Liter (mg/L)
Standard Deviation 0.89837
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 3, predose, n=3,0
|
7.4697 Milligrams per Liter (mg/L)
Standard Deviation 5.41886
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 3, 2 hour, n=3,0
|
8.3574 Milligrams per Liter (mg/L)
Standard Deviation 4.40865
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 3, 4 hour, n=3,0
|
11.0305 Milligrams per Liter (mg/L)
Standard Deviation 8.80978
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 3, 8 hour, n=3,0
|
14.5333 Milligrams per Liter (mg/L)
Standard Deviation 12.26460
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 5, n=3,0
|
25.2529 Milligrams per Liter (mg/L)
Standard Deviation 27.55204
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 6, Day 6, n=3,0
|
32.6318 Milligrams per Liter (mg/L)
Standard Deviation 41.82856
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 1, predose, n=5,1
|
-0.12 Milligrams per Liter (mg/L)
Standard Deviation 0.572
|
-4.60 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 1, 2 hour, n=5,1
|
-0.26 Milligrams per Liter (mg/L)
Standard Deviation 0.573
|
-4.80 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 1, 4 hour, n=4,1
|
-0.28 Milligrams per Liter (mg/L)
Standard Deviation 0.486
|
-4.70 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 1, 8 hour, n=5,1
|
-0.18 Milligrams per Liter (mg/L)
Standard Deviation 0.634
|
-4.60 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 3, predose, n=5,1
|
14.08 Milligrams per Liter (mg/L)
Standard Deviation 12.511
|
131.20 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 3, 2 hour, n=5,0
|
14.52 Milligrams per Liter (mg/L)
Standard Deviation 13.128
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 3, 4 hour, n=5,0
|
15.30 Milligrams per Liter (mg/L)
Standard Deviation 13.119
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 3, 8 hour, n=5,0
|
17.64 Milligrams per Liter (mg/L)
Standard Deviation 14.527
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 5, n=5,0
|
17.20 Milligrams per Liter (mg/L)
Standard Deviation 14.772
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 1, Day 6, n=5,0
|
19.52 Milligrams per Liter (mg/L)
Standard Deviation 15.665
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 1, predose, n=5,0
|
2.24 Milligrams per Liter (mg/L)
Standard Deviation 2.864
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 1, 2 hour, n=5,0
|
2.12 Milligrams per Liter (mg/L)
Standard Deviation 2.613
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 1, 4 hour, n=5,0
|
2.18 Milligrams per Liter (mg/L)
Standard Deviation 2.710
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 1, 8 hour, n=5,0
|
2.18 Milligrams per Liter (mg/L)
Standard Deviation 2.658
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 2, n=4,0
|
2.00 Milligrams per Liter (mg/L)
Standard Deviation 2.624
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 3, predose, n=5,0
|
27.42 Milligrams per Liter (mg/L)
Standard Deviation 26.283
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 3, 2 hour, n=5,0
|
29.46 Milligrams per Liter (mg/L)
Standard Deviation 27.415
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 3, 4 hour, n=5,0
|
30.90 Milligrams per Liter (mg/L)
Standard Deviation 27.961
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 3, 8 hour, n=5,0
|
31.76 Milligrams per Liter (mg/L)
Standard Deviation 27.897
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 5, n=4,0
|
28.33 Milligrams per Liter (mg/L)
Standard Deviation 22.386
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 2, Day 6, n=5,0
|
27.04 Milligrams per Liter (mg/L)
Standard Deviation 18.632
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 1, predose, n=4,0
|
1.93 Milligrams per Liter (mg/L)
Standard Deviation 2.343
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 1, 2 hour, n=4,0
|
2.05 Milligrams per Liter (mg/L)
Standard Deviation 2.626
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 1, 4 hour, n=4,0
|
2.15 Milligrams per Liter (mg/L)
Standard Deviation 2.891
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 1, 8 hour, n=4,0
|
2.15 Milligrams per Liter (mg/L)
Standard Deviation 2.760
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 3, predose, n=4,0
|
18.13 Milligrams per Liter (mg/L)
Standard Deviation 15.476
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 3, 4 hour, n=4,0
|
21.20 Milligrams per Liter (mg/L)
Standard Deviation 17.827
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 5, n=5,0
|
19.00 Milligrams per Liter (mg/L)
Standard Deviation 15.625
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 3, Day 6, n=4,0
|
24.10 Milligrams per Liter (mg/L)
Standard Deviation 16.785
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 1, predose, n=4,0
|
2.33 Milligrams per Liter (mg/L)
Standard Deviation 4.487
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 1, 2 hour, n=4,0
|
2.53 Milligrams per Liter (mg/L)
Standard Deviation 4.762
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 1, 4 hour, n=4,0
|
2.45 Milligrams per Liter (mg/L)
Standard Deviation 4.669
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 3, predose, n=4,0
|
12.45 Milligrams per Liter (mg/L)
Standard Deviation 13.533
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 3, 2 hour, n=4,0
|
14.75 Milligrams per Liter (mg/L)
Standard Deviation 16.539
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 3, 4 hour, n=4,0
|
16.75 Milligrams per Liter (mg/L)
Standard Deviation 19.129
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 3, 8 hour, n=4,0
|
17.30 Milligrams per Liter (mg/L)
Standard Deviation 17.830
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 5, n=4,0
|
18.43 Milligrams per Liter (mg/L)
Standard Deviation 9.959
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 4, Day 6, n=4,0
|
19.98 Milligrams per Liter (mg/L)
Standard Deviation 11.277
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 1, predose, n=3,0
|
2.23 Milligrams per Liter (mg/L)
Standard Deviation 3.439
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 1, 2 hour, n=3,0
|
2.13 Milligrams per Liter (mg/L)
Standard Deviation 3.350
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 1, 4 hour, n=3,0
|
1.97 Milligrams per Liter (mg/L)
Standard Deviation 3.147
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 3, predose, n=3,0
|
8.33 Milligrams per Liter (mg/L)
Standard Deviation 11.517
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 3, 2 hour, n=3,0
|
9.87 Milligrams per Liter (mg/L)
Standard Deviation 12.881
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 3, 4 hour, n=3,0
|
10.47 Milligrams per Liter (mg/L)
Standard Deviation 12.874
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 3, 8 hour, n=3,0
|
12.90 Milligrams per Liter (mg/L)
Standard Deviation 14.944
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 5, n=2,0
|
34.30 Milligrams per Liter (mg/L)
Standard Deviation 40.588
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 5, Day 6, n=2,0
|
35.20 Milligrams per Liter (mg/L)
Standard Deviation 34.931
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 1, predose, n=3,0
|
4.00 Milligrams per Liter (mg/L)
Standard Deviation 3.851
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 1, 2 hour, n=3,0
|
3.63 Milligrams per Liter (mg/L)
Standard Deviation 3.711
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 1, 4 hour, n=3,0
|
3.70 Milligrams per Liter (mg/L)
Standard Deviation 3.835
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 3, predose, n=3,0
|
9.17 Milligrams per Liter (mg/L)
Standard Deviation 8.879
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 3, 2 hour, n=3,0
|
11.10 Milligrams per Liter (mg/L)
Standard Deviation 10.887
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 3, 4 hour, n=3,0
|
12.70 Milligrams per Liter (mg/L)
Standard Deviation 11.555
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 5, n=3,0
|
14.10 Milligrams per Liter (mg/L)
Standard Deviation 7.146
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
CRP, Session 6, Day 6, n=3,0
|
17.33 Milligrams per Liter (mg/L)
Standard Deviation 7.844
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 1, predose, n=5,1
|
-0.08 Milligrams per Liter (mg/L)
Standard Deviation 0.356
|
-3.60 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 1, 2 hour, n=5,1
|
-0.08 Milligrams per Liter (mg/L)
Standard Deviation 0.327
|
-3.70 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 3, predose, n=5,1
|
14.54 Milligrams per Liter (mg/L)
Standard Deviation 13.149
|
135.20 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 3, 2 hour, n=5,0
|
15.14 Milligrams per Liter (mg/L)
Standard Deviation 13.363
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 3, 8 hour, n=5,0
|
17.10 Milligrams per Liter (mg/L)
Standard Deviation 14.294
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 5, n=5,0
|
16.70 Milligrams per Liter (mg/L)
Standard Deviation 14.332
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 1, Day 6, n=5,0
|
18.60 Milligrams per Liter (mg/L)
Standard Deviation 14.778
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 1, predose, n=5,0
|
1.88 Milligrams per Liter (mg/L)
Standard Deviation 2.539
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 1, 2 hour, n=5,0
|
1.78 Milligrams per Liter (mg/L)
Standard Deviation 2.351
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 1, 4 hour, n=5,0
|
1.90 Milligrams per Liter (mg/L)
Standard Deviation 2.478
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 1, 8 hour, n=5,0
|
1.78 Milligrams per Liter (mg/L)
Standard Deviation 2.179
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 2, n=4,0
|
1.75 Milligrams per Liter (mg/L)
Standard Deviation 2.266
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 3, predose, n=5,0
|
26.76 Milligrams per Liter (mg/L)
Standard Deviation 26.122
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 3, 2 hour, n=5,0
|
29.28 Milligrams per Liter (mg/L)
Standard Deviation 27.373
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 3, 4 hour, n=5,0
|
30.36 Milligrams per Liter (mg/L)
Standard Deviation 27.018
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 5, n=4,0
|
28.13 Milligrams per Liter (mg/L)
Standard Deviation 21.919
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 2, Day 6, n=5,0
|
27.20 Milligrams per Liter (mg/L)
Standard Deviation 18.468
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 1, predose, n=4,0
|
1.60 Milligrams per Liter (mg/L)
Standard Deviation 2.017
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 1, 2 hour, n=4,0
|
1.63 Milligrams per Liter (mg/L)
Standard Deviation 2.175
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 1, 4 hour, n=4,0
|
1.70 Milligrams per Liter (mg/L)
Standard Deviation 2.403
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 1, 8 hour, n=4,0
|
1.65 Milligrams per Liter (mg/L)
Standard Deviation 2.161
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 2, n=4,0
|
1.25 Milligrams per Liter (mg/L)
Standard Deviation 1.754
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 3, predose, n=4,0
|
17.88 Milligrams per Liter (mg/L)
Standard Deviation 15.954
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 3, 2 hour, n=4,0
|
19.23 Milligrams per Liter (mg/L)
Standard Deviation 16.675
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 3, 4 hour, n=4,0
|
20.58 Milligrams per Liter (mg/L)
Standard Deviation 17.733
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 3, 8 hour, n=4,0
|
22.10 Milligrams per Liter (mg/L)
Standard Deviation 18.149
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 5, n=4,0
|
22.45 Milligrams per Liter (mg/L)
Standard Deviation 15.042
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 3, Day 6, n=4,0
|
23.73 Milligrams per Liter (mg/L)
Standard Deviation 16.141
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 1, predose, n=4,0
|
2.28 Milligrams per Liter (mg/L)
Standard Deviation 4.043
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 1, 2 hour, n=4,0
|
2.53 Milligrams per Liter (mg/L)
Standard Deviation 4.610
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 1, 4 hour, n=4,0
|
2.53 Milligrams per Liter (mg/L)
Standard Deviation 4.479
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 1, 8 hour, n=4,0
|
2.58 Milligrams per Liter (mg/L)
Standard Deviation 4.528
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 2, n=4,0
|
2.20 Milligrams per Liter (mg/L)
Standard Deviation 3.558
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 3, predose, n=4,0
|
12.33 Milligrams per Liter (mg/L)
Standard Deviation 13.881
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 3, 2 hour, n=4,0
|
14.40 Milligrams per Liter (mg/L)
Standard Deviation 16.324
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 3, 4 hour, n=4,0
|
16.00 Milligrams per Liter (mg/L)
Standard Deviation 18.240
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 3, 8 hour, n=4,0
|
17.08 Milligrams per Liter (mg/L)
Standard Deviation 17.972
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 5, n=4,0
|
19.60 Milligrams per Liter (mg/L)
Standard Deviation 10.903
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 4, Day 6, n=4,0
|
20.73 Milligrams per Liter (mg/L)
Standard Deviation 11.391
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 1, 4 hour, n=3,0
|
1.83 Milligrams per Liter (mg/L)
Standard Deviation 3.175
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 1, 8 hour, n=3,0
|
1.87 Milligrams per Liter (mg/L)
Standard Deviation 3.323
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 2, n=3,0
|
1.23 Milligrams per Liter (mg/L)
Standard Deviation 2.574
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 3, predose, n=3,0
|
9.10 Milligrams per Liter (mg/L)
Standard Deviation 13.182
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 3, 2 hour, n=3,0
|
10.43 Milligrams per Liter (mg/L)
Standard Deviation 14.629
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 3, 4 hour, n=3,0
|
11.17 Milligrams per Liter (mg/L)
Standard Deviation 14.865
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 3, 8 hour, n=3,0
|
12.67 Milligrams per Liter (mg/L)
Standard Deviation 15.557
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 5, n=2,0
|
33.95 Milligrams per Liter (mg/L)
Standard Deviation 40.941
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 5, Day 6, n=2,0
|
34.80 Milligrams per Liter (mg/L)
Standard Deviation 34.083
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 1, predose, n=3,0
|
3.77 Milligrams per Liter (mg/L)
Standard Deviation 3.853
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 1, 2 hour, n=3,0
|
3.37 Milligrams per Liter (mg/L)
Standard Deviation 3.523
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 3, 2 hour, n=3,0
|
10.57 Milligrams per Liter (mg/L)
Standard Deviation 11.075
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 3, 4 hour, n=3,0
|
12.60 Milligrams per Liter (mg/L)
Standard Deviation 12.322
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
hsCRP, Session 6, Day 3, 8 hour, n=3,0
|
15.33 Milligrams per Liter (mg/L)
Standard Deviation 14.276
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 1, predose, n=5,1
|
0.2164 Milligrams per Liter (mg/L)
Standard Deviation 1.55486
|
-22.3723 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 1, 8 hour, n=5,1
|
0.2695 Milligrams per Liter (mg/L)
Standard Deviation 1.57992
|
-14.8767 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 3, predose, n=5,1
|
50.7137 Milligrams per Liter (mg/L)
Standard Deviation 55.02969
|
1437.7667 Milligrams per Liter (mg/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 3, 8 hour, n=5,0
|
68.4699 Milligrams per Liter (mg/L)
Standard Deviation 75.51138
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 5, n=5,0
|
54.6741 Milligrams per Liter (mg/L)
Standard Deviation 69.66316
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 1, Day 6, n=5,0
|
55.2882 Milligrams per Liter (mg/L)
Standard Deviation 63.77870
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 1, predose, n=5,0
|
1.0277 Milligrams per Liter (mg/L)
Standard Deviation 1.64965
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 1, 2 hour, n=5,0
|
0.9841 Milligrams per Liter (mg/L)
Standard Deviation 2.22042
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 1, 4 hour, n=5,0
|
1.4543 Milligrams per Liter (mg/L)
Standard Deviation 2.61184
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 1, 8 hour, n=5,0
|
1.0588 Milligrams per Liter (mg/L)
Standard Deviation 1.52455
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 2, n=5,0
|
3.7244 Milligrams per Liter (mg/L)
Standard Deviation 1.63856
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 3, 2 hour, n=5,0
|
145.2507 Milligrams per Liter (mg/L)
Standard Deviation 171.92591
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 3, 4 hour, n=5,0
|
142.5438 Milligrams per Liter (mg/L)
Standard Deviation 174.11156
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 3, 8 hour, n=5,0
|
100.8836 Milligrams per Liter (mg/L)
Standard Deviation 184.35963
|
—
|
|
Change From Baseline in Inflammatory Biomarkers Over Time
SAA, Session 2, Day 6, n=5,0
|
101.0688 Milligrams per Liter (mg/L)
Standard Deviation 105.88787
|
—
|
SECONDARY outcome
Timeframe: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Maximum Concentration (Cmax) of GSK2398852
Session 1, n=6,1
|
86.94 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 31.58
|
88.64 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
|
Maximum Concentration (Cmax) of GSK2398852
Session 2, n=6,0
|
235.48 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 25.22
|
—
|
|
Maximum Concentration (Cmax) of GSK2398852
Session 3, n=6,0
|
222.23 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 44.40
|
—
|
|
Maximum Concentration (Cmax) of GSK2398852
Session 4, n=5,0
|
179.82 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 33.87
|
—
|
|
Maximum Concentration (Cmax) of GSK2398852
Session 5, n=4,0
|
185.52 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 34.06
|
—
|
|
Maximum Concentration (Cmax) of GSK2398852
Session 6, n=4,0
|
228.51 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 49.73
|
—
|
SECONDARY outcome
Timeframe: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 1, n=6,1
|
54.18 Hour
Interval 53.9 to 54.9
|
6.1 Hour
Interval 6.1 to 6.1
|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 2, n=6,0
|
54.07 Hour
Interval 53.3 to 54.7
|
—
|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 3, n=6,0
|
54.06 Hour
Interval 12.1 to 55.8
|
—
|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 4, n=5,0
|
54.50 Hour
Interval 53.9 to 56.1
|
—
|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 5, n=4,0
|
54.28 Hour
Interval 6.1 to 56.1
|
—
|
|
Time Associated With Cmax (Tmax) of GSK2398852
Session 6, n=4,0
|
54.18 Hour
Interval 53.9 to 56.0
|
—
|
SECONDARY outcome
Timeframe: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 1, n=6,1
|
5130.0 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 46.72
|
2148.2 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 2, n=6,0
|
14610.1 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 34.73
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 3, n=6,0
|
13804.6 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 50.34
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 4, n=5,0
|
12970.9 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 51.52
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 5, n=4,0
|
15595.3 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 51.13
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Session 6, n=4,0
|
17126.7 Hour*micrograms per milliliter (h*ug/mL)
Geometric Coefficient of Variation 43.98
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.'
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days)Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, Session 5, Day 24, n=4,0
|
0.349 Percentage of myocardial shortening
Standard Deviation 0.9354
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, 8 Week follow-up, n=6,1
|
1.125 Percentage of myocardial shortening
Standard Deviation 1.6448
|
-3.404 Percentage of myocardial shortening
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, Session 4, Day 24, n=5,0
|
1.326 Percentage of myocardial shortening
Standard Deviation 4.0639
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, Session 5, Day 24, n=4,0
|
1.657 Percentage of myocardial shortening
Standard Deviation 2.1277
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, Session 2, Day 24, n=6,0
|
0.003 Percentage of myocardial shortening
Standard Deviation 0.2907
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, Session 3, Day 24, n=6,0
|
0.229 Percentage of myocardial shortening
Standard Deviation 0.5836
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, Session 4, Day 24, n=5,0
|
0.392 Percentage of myocardial shortening
Standard Deviation 0.4121
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Tagging, 6 month follow-up, n=2,0
|
-1.014 Percentage of myocardial shortening
Standard Deviation 0.3654
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, Session 2, Day 24, n=6,0
|
1.729 Percentage of myocardial shortening
Standard Deviation 2.3613
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, Session 3, Day 24, n=6,0
|
0.803 Percentage of myocardial shortening
Standard Deviation 2.3712
|
—
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, 8 Week follow-up, n=6,1
|
0.639 Percentage of myocardial shortening
Standard Deviation 1.3678
|
3.951 Percentage of myocardial shortening
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
GLS Feature Tracking, 6 month follow-up, n=2,0
|
1.234 Percentage of myocardial shortening
Standard Deviation 4.6888
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 1, Day 24, n=6,1
|
-3.55 Percentage of myocardial shortening
Standard Deviation 5.709
|
-0.90 Percentage of myocardial shortening
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 5, Day 24, n=4,0
|
1.13 Percentage of myocardial shortening
Standard Deviation 9.044
|
—
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, 8 Week follow-up, n=6,1
|
-1.82 Percentage of myocardial shortening
Standard Deviation 10.013
|
1.60 Percentage of myocardial shortening
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 2, Day 24, n=6,0
|
-0.58 Percentage of myocardial shortening
Standard Deviation 6.013
|
—
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 3, Day 24, n=6,0
|
-1.17 Percentage of myocardial shortening
Standard Deviation 7.487
|
—
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 4, Day 24, n=5,0
|
1.26 Percentage of myocardial shortening
Standard Deviation 5.299
|
—
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, Session 6, Day 24, n=4,0
|
-2.08 Percentage of myocardial shortening
Standard Deviation 4.555
|
—
|
|
Change From Baseline in GLS by ECHO
GLS Speckle Tracking, 6 month follow-up, n=4,0
|
0.40 Percentage of myocardial shortening
Standard Deviation 4.268
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in LV Twist Over Time
8 Week follow-up, n=6,1
|
-0.264 Degree
Standard Deviation 2.0835
|
0.914 Degree
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in LV Twist Over Time
6 month follow-up, n=2,0
|
-0.633 Degree
Standard Deviation 0.3349
|
—
|
|
Change From Baseline in LV Twist Over Time
Session 2, Day 24, n=5,0
|
0.550 Degree
Standard Deviation 1.6672
|
—
|
|
Change From Baseline in LV Twist Over Time
Session 3, Day 24, n=6,0
|
0.431 Degree
Standard Deviation 2.4369
|
—
|
|
Change From Baseline in LV Twist Over Time
Session 4, Day 24, n=5,0
|
-0.611 Degree
Standard Deviation 1.8979
|
—
|
|
Change From Baseline in LV Twist Over Time
Session 5, Day 24, n=4,0
|
-0.628 Degree
Standard Deviation 1.2269
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Stroke Volume (SV) by CMR
Session 5, Day 24, n=4,0
|
-11.477 Milliliter
Standard Deviation 14.4238
|
—
|
|
Change From Baseline in Stroke Volume (SV) by CMR
Session 2, Day 24, n=6,0
|
-2.760 Milliliter
Standard Deviation 7.8305
|
—
|
|
Change From Baseline in Stroke Volume (SV) by CMR
Session 3, Day 24, n=6,0
|
-1.228 Milliliter
Standard Deviation 24.3834
|
—
|
|
Change From Baseline in Stroke Volume (SV) by CMR
Session 4, Day 24, n=5,0
|
-9.766 Milliliter
Standard Deviation 9.7838
|
—
|
|
Change From Baseline in Stroke Volume (SV) by CMR
8 Week follow-up, n=6,1
|
2.400 Milliliter
Standard Deviation 19.1252
|
-6.750 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Stroke Volume (SV) by CMR
6 month follow-up, n=2,0
|
-6.160 Milliliter
Standard Deviation 12.0491
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in SV by ECHO
Session 4, Day 24, n=5,0
|
-7.484 Milliliter
Standard Deviation 6.5228
|
—
|
|
Change From Baseline in SV by ECHO
Session 1, Day 24, n=6,1
|
2.580 Milliliter
Standard Deviation 5.4518
|
-5.640 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in SV by ECHO
Session 2, Day 24, n=6,0
|
-1.885 Milliliter
Standard Deviation 4.6569
|
—
|
|
Change From Baseline in SV by ECHO
Session 3, Day 24, n=6,0
|
-1.398 Milliliter
Standard Deviation 8.0106
|
—
|
|
Change From Baseline in SV by ECHO
Session 5, Day 24, n=4,0
|
-9.043 Milliliter
Standard Deviation 9.5173
|
—
|
|
Change From Baseline in SV by ECHO
Session 6, Day 24, n=4,0
|
-5.095 Milliliter
Standard Deviation 7.1431
|
—
|
|
Change From Baseline in SV by ECHO
8 Week follow-up, n=6,1
|
-4.343 Milliliter
Standard Deviation 7.3457
|
-6.490 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in SV by ECHO
6 month follow-up, n=4,0
|
-4.275 Milliliter
Standard Deviation 9.9743
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
8 Week follow-up, n=6,1
|
-1.258 Percentage of ejected blood
Standard Deviation 7.9932
|
-2.800 Percentage of ejected blood
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Session 2, Day 24, n=6,0
|
0.100 Percentage of ejected blood
Standard Deviation 3.9071
|
—
|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Session 3, Day 24, n=6,0
|
0.687 Percentage of ejected blood
Standard Deviation 11.7171
|
—
|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Session 4, Day 24, n=5,0
|
-3.380 Percentage of ejected blood
Standard Deviation 5.4750
|
—
|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Session 5, Day 24, n=4,0
|
-3.257 Percentage of ejected blood
Standard Deviation 7.9513
|
—
|
|
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
6 month follow-up, n=2,0
|
0.680 Percentage of ejected blood
Standard Deviation 8.7681
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 1, Day 24, n=6,1
|
2.10 Percentage of ejected blood
Standard Deviation 5.707
|
-7.40 Percentage of ejected blood
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 2, Day 24, n=6,0
|
-0.38 Percentage of ejected blood
Standard Deviation 3.111
|
—
|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 3, Day 24, n=6,0
|
-0.30 Percentage of ejected blood
Standard Deviation 3.318
|
—
|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 4, Day 24, n=5,0
|
-2.74 Percentage of ejected blood
Standard Deviation 5.766
|
—
|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 5, Day 24, n=4,0
|
-4.05 Percentage of ejected blood
Standard Deviation 7.832
|
—
|
|
Change From Baseline in Left Ventricular EF by ECHO
Session 6, Day 24, n=4,0
|
-3.53 Percentage of ejected blood
Standard Deviation 3.288
|
—
|
|
Change From Baseline in Left Ventricular EF by ECHO
8 Week follow-up, n=6,1
|
-1.72 Percentage of ejected blood
Standard Deviation 8.471
|
-3.20 Percentage of ejected blood
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Left Ventricular EF by ECHO
6 month follow-up, n=4,0
|
1.20 Percentage of ejected blood
Standard Deviation 3.442
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
Session 2, Day 24, n=6,0
|
-3.473 Milliliter
Standard Deviation 11.2584
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
Session 3, Day 24, n=6,0
|
1.653 Milliliter
Standard Deviation 7.3322
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
Session 4, Day 24, n=5,0
|
-5.262 Milliliter
Standard Deviation 5.3765
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
Session 5, Day 24, n=4,0
|
-9.323 Milliliter
Standard Deviation 11.5275
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
8 Week follow-up, n=6,1
|
9.887 Milliliter
Standard Deviation 19.3925
|
-4.560 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
6 month follow-up, n=2,0
|
-21.030 Milliliter
Standard Deviation 8.0469
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 3, Day 24, n=6,0
|
-2.922 Milliliter
Standard Deviation 14.0019
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
6 month follow-up, n=4,0
|
-12.045 Milliliter
Standard Deviation 20.2972
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 1, Day 24, n=6,1
|
0.050 Milliliter
Standard Deviation 4.6276
|
-1.790 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 2, Day 24, n=6,0
|
-2.940 Milliliter
Standard Deviation 10.2320
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 4, Day 24, n=5,0
|
-12.338 Milliliter
Standard Deviation 10.2249
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 5, Day 24, n=4,0
|
-11.860 Milliliter
Standard Deviation 14.5676
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Session 6, Day 24, n=4,0
|
-5.073 Milliliter
Standard Deviation 11.3679
|
—
|
|
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
8 Week follow-up, n=6,1
|
-7.648 Milliliter
Standard Deviation 4.4630
|
-7.100 Milliliter
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-upPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 Participants
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 Participants
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 1, Day 24, n=6,1
|
-1.55 Ratio
Standard Deviation 2.813
|
-2.80 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 2, Day 24, n=6,0
|
-0.77 Ratio
Standard Deviation 3.555
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 1, Day 24, n=6,1
|
0.50 Ratio
Standard Deviation 2.995
|
-2.00 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 6, Day 24, n=4,0
|
6.23 Ratio
Standard Deviation 5.917
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 3, Day 24, n=6,0
|
3.20 Ratio
Standard Deviation 2.197
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 4, Day 24, n=5,0
|
-0.64 Ratio
Standard Deviation 4.750
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 5, Day 24, n=4,0
|
1.22 Ratio
Standard Deviation 5.134
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, Session 6, Day 24, n=4,0
|
3.25 Ratio
Standard Deviation 2.300
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, 8 Week follow-up, n=6,1
|
0.05 Ratio
Standard Deviation 2.681
|
2.90 Ratio
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Lateral Ratio, 6 month follow-up, n=4,0
|
-0.58 Ratio
Standard Deviation 4.442
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 2, Day 24, n=6,0
|
0.52 Ratio
Standard Deviation 4.640
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 3, Day 24, n=6,0
|
5.33 Ratio
Standard Deviation 5.136
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 4, Day 24, n=5,0
|
2.96 Ratio
Standard Deviation 3.462
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, Session 5, Day 24, n=4,0
|
4.48 Ratio
Standard Deviation 3.010
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, 8 Week follow-up, n=6,0
|
2.83 Ratio
Standard Deviation 4.236
|
—
|
|
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e Septal Ratio, 6 month follow-up, n=4,0
|
4.95 Ratio
Standard Deviation 1.708
|
—
|
Adverse Events
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Post-chemotherapy AL Amyloidosis Participants
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 participants at risk
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 participants at risk
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Cardiac disorders
Cardiac failure
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
Other adverse events
| Measure |
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants
n=6 participants at risk
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
|
Group 2: Post-chemotherapy AL Amyloidosis Participants
n=1 participants at risk
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 5 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
50.0%
3/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
33.3%
2/6 • Number of events 6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Catheter site bruise
|
50.0%
3/6 • Number of events 6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 9 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Injection site bruising
|
33.3%
2/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Catheter site dermatitis
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Catheter site erythema
|
0.00%
0/6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Catheter site related reaction
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Feeling cold
|
0.00%
0/6 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Secretion discharge
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Thirst
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
General disorders
Vessel puncture site bruise
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Somnolence
|
33.3%
2/6 • Number of events 8 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Ageusia
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Depressed level of consciousness
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Cardiac disorders
Ventricular tachycardia
|
33.3%
2/6 • Number of events 33 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Cardiac disorders
Cardiac failure
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Cardiac disorders
Ventricular extrasystoles
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
33.3%
2/6 • Number of events 4 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Lip injury
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Nail injury
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Vascular disorders
Flushing
|
50.0%
3/6 • Number of events 12 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Vascular disorders
Haemorrhage
|
16.7%
1/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Investigations
Liver function test increased
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Investigations
Urine output increased
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Reproductive system and breast disorders
Nipple pain
|
16.7%
1/6 • Number of events 1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 8 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
0.00%
0/1 • Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).
SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER