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Clinical Trial Results:
A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis

Summary
EudraCT number	2016-000276-23
Trial protocol	GB
Global end of trial date	03 Jan 2019

Results information
Results version number	v1(current)
This version publication date	12 Oct 2019
First version publication date	12 Oct 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

201464

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Aug 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Jan 2019

Was the trial ended prematurely?

Yes

Main objective of the trial

- Assessment of reduction in cardiac amyloid load after repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups - Assessment of safety & tolerability of repeated administration of Anti-SAP treatment, including compatibility with chemotherapy treatment in Group 3

Protection of trial subjects

Not applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Jul 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 6

Country: Number of subjects enrolled

United States: 1

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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.

Screening details

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).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

CPHPC IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During each anti-SAP treatments, participants received CPHPC IV infusion once daily for up to 72 hours prior to initial mAb dose.

Investigational medicinal product name

CPHPC SC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

In each treatment session, CPHPC was administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.

Investigational medicinal product name

anti-SAP mAb

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Anti-SAP mAb was administered as an IV infusion over 2 days (Days 1 and 3) with 6-8 hour infusion per day. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg).

Group 2: Post-chemotherapy AL Amyloidosis participants

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

CPHPC IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

During each anti-SAP treatments, participants received CPHPC IV infusion once daily for up to 72 hours prior to initial mAb dose.

Investigational medicinal product name

anti-SAP mAb

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Anti-SAP mAb was administered as an IV infusion over 2 days (Days 1 and 3) with 6-8 hour infusion per day. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg).

Investigational medicinal product name

CPHPC SC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

In each treatment session, CPHPC was administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.

Number of subjects in period 1	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Started	6	1
Completed	6	0
Not completed	0	1
Adverse event, non-fatal	-	1

Baseline characteristics

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Reporting group title

Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants

Reporting group description

Reporting group title

Group 2: Post-chemotherapy AL Amyloidosis participants

Reporting group description

Reporting group values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants	Total
Number of subjects	6	1	7
Age categorical
Units: Subjects
Total participants	6	1	7
Age Continuous
'99' or '99999' indicates data was not available.
Units: years
arithmetic mean (standard deviation)	74.3 ( 3.27 )	67.0 ( 99999 )	-
Sex: Female, Male
Units: Subjects
Female	0	0	0
Male	6	1	7
Race/Ethnicity, Customized
Units: Subjects
White/Caucasian/European Heritage	6	1	7

End points

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Reporting group title

Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants

Reporting group description

Reporting group title

Group 2: Post-chemotherapy AL Amyloidosis participants

Reporting group description

Primary: Change from Baseline in left ventricular (LV) mass over time up to 8-week follow-up

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End point title

Change from Baseline in left ventricular (LV) mass over time up to 8-week follow-up ^[1]

End point description

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]). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available as standard deviation could not be calculated as only one participant was analyzed.

End point type

Primary

End point 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

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[2]	1 ^[3]
Units: Grams
arithmetic mean (standard deviation)
Session 2, Day 24, n=6,0	2.505 ( 19.9174 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	4.175 ( 22.9366 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	9.194 ( 14.4271 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	7.955 ( 19.4341 )	99999 ( 99999 )
8 Weeks Follow up, n=6,1	0.977 ( 12.1795 )	-32.420 ( 88888 )

Notes
[2] - Safety Population
[3] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with any on-treatment adverse events (AEs)

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End point title

Number of participants with any on-treatment adverse events (AEs) ^[4]

End point description

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.

End point type

Primary

End point timeframe

Up to 56 days after the last dosing session (up to 265 days)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[5]	1 ^[6]
Units: Participants	6	1

Notes
[5] - Safety Population
[6] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with any serious adverse events (SAEs)

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End point title

Number of participants with any serious adverse events (SAEs) ^[7]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[8]	1 ^[9]
Units: Participants	2	1

Notes
[8] - Safety Population
[9] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormal hematology values

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End point title

Number of participants with abnormal hematology values ^[10]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[11]	1 ^[12]
Units: Participants
Basophils, high	2	0
Basophils, normal	4	1
Basophils, low	0	0
Eosinophils, high	3	0
Eosinophils, normal	3	1
Eosinophils, low	0	0
Hematocrit, high	0	0
Hematocrit, normal	1	0
Hematocrit, low	5	1
Hemoglobin, high	0	0
Hemoglobin, normal	0	0
Hemoglobin, low	6	1
Lymphocytes, high	1	0
Lymphocytes, normal	0	0
Lymphocytes, low	6	1
MCH, high	1	0
MCH, normal	3	1
MCH, low	3	0
MCHC, high	3	0
MCHC, normal	1	1
MCHC, low	2	0
MCV, high	1	0
MCV, normal	4	1
MCV, low	2	0
Monocytes, high	2	1
Monocytes, normal	4	0
Monocytes, low	0	0
Neutrophils, high	5	1
Neutrophils, normal	0	0
Neutrophils, low	4	0
Platelet count, high	1	0
Platelet count, normal	3	0
Platelet count, low	2	1
Erythrocytes, high	0	0
Erythrocytes, normal	0	0
Erythrocytes, low	6	1
Reticulocytes, high	1	0
Reticulocytes, normal	5	1
Reticulocytes, low	0	0
Leukocytes, high	2	1
Leukocytes, normal	3	0
Leukocytes, low	1	0

Notes
[11] - Safety Population
[12] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormal clinical chemistry values

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End point title

Number of participants with abnormal clinical chemistry values ^[13]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[14]	1 ^[15]
Units: Participants
Glucose, high	6	1
Glucose, normal	0	0
Glucose, low	0	0
Albumin, high	0	0
Albumin, normal	2	1
Albumin, low	4	0
ALP, high	5	0
ALP, normal	1	1
ALP, low	0	0
ALT, high	2	1
ALT, normal	4	0
ALT, low	0	0
AST, high	4	1
AST, normal	2	0
AST, low	0	0
Direct Bilirubin, high	4	1
Direct Bilirubin, normal	2	0
Direct Bilirubin, low	0	0
Total Bilirubin, high	4	0
Total Bilirubin, normal	2	1
Total Bilirubin, low	0	0
Calcium, high	0	0
Calcium, normal	4	0
Calcium, low	2	1
Creatinine Kinase, high	1	0
Creatinine Kinase, normal	3	1
Creatinine Kinase, low	2	0
Chloride, high	0	0
Chloride, normal	1	0
Chloride, low	5	1
CO2, high	6	0
CO2, normal	0	1
CO2, low	4	0
Creatinine, high	4	0
Creatinine, normal	2	1
Creatinine, low	0	0
Potassium, high	2	0
Potassium, normal	3	1
Potassium, low	2	0
LDH, high	6	1
LDH, normal	0	0
LDH, low	0	0
Protein, high	0	0
Protein, normal	0	0
Protein, low	6	1
Sodium, high	1	0
Sodium, normal	5	1
Sodium, low	0	0
Urate, high	5	1
Urate, normal	1	0
Urate, low	0	0
Urea, high	6	1
Urea, normal	0	0
Urea, low	0	0

Notes
[14] - Safety Population
[15] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormal urinalysis results

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End point title

Number of participants with abnormal urinalysis results ^[16]

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[17]	1 ^[18]
Units: Participants
pH, high, n=6,1	0	0
pH, normal, n=6,1	6	1
pH, low, n=6,1	0	0
Specific gravity, high, n=1,0	0	99999
Specific gravity, normal, n=1,0	1	99999
Specific gravity, low, n=1,0	0	99999
Albumin excretion rate, high, n=6,1	0	0
Albumin excretion rate, normal, n=6,1	6	1
Albumin excretion rate, low, n=6,1	0	0
Creatinine excretion rate, high, n=6,1	1	0
Creatinine excretion rate, normal, n=6,1	1	1
Creatinine excretion rate, low, n=6,1	5	0
Protein excretion rate, high, n=6,1	4	1
Protein excretion rate, normal, n=6,1	2	0
Protein excretion rate, low, n=6,1	0	0

Notes
[17] - Safety Population
[18] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormal urinalysis results for character parameters

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End point title

Number of participants with abnormal urinalysis results for character parameters ^[19]

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[20]	1 ^[21]
Units: Participants
Cellular casts, n=5,1	0	0
Erythrocytes , n=6,1	6	1
Glucose, n=6,1	1	0
Ketones, n=6,1	0	0
Leukocytes, n=6,1	6	1
Occult blood, n=6,1	2	1

Notes
[20] - Safety Population
[21] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with body temperature shifts from Baseline relative to potential clinical importance (PCI) criteria

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End point title

Number of participants with body temperature shifts from Baseline relative to potential clinical importance (PCI) criteria ^[22]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[23]	1 ^[24]
Units: Participants
To high	2	0
To normal/No change	4	1
To low	0	0

Notes
[23] - Safety Population
[24] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with systolic blood pressure (SBP) and diastolic blood pressure (DBP) shifts from Baseline relative to PCI criteria

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End point title

Number of participants with systolic blood pressure (SBP) and diastolic blood pressure (DBP) shifts from Baseline relative to PCI criteria ^[25]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[26]	1 ^[27]
Units: Participants
SBP, To high	0	0
SBP, To normal/No change	1	1
SBP, To low	5	0
DBP, To high	0	0
DBP, To normal/No change	6	1
DBP, To low	0	0

Notes
[26] - Safety Population
[27] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with pulse rate shifts from Baseline relative to PCI criteria

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End point title

Number of participants with pulse rate shifts from Baseline relative to PCI criteria ^[28]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[29]	1 ^[30]
Units: Participants
To high	0	0
To normal/No change	6	1
To low	0	0

Notes
[29] - Safety Population
[30] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormal electrocardiogram (ECG) findings

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End point title

Number of participants with abnormal electrocardiogram (ECG) findings ^[31]

End point description

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.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[32]	1 ^[33]
Units: Participants
Abnormal-Clinically significant	0	0
Abnormal-Not Clinically significant	6	1

Notes
[32] - Safety Population
[33] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with abnormalities during cardiac monitoring

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End point title

Number of participants with abnormalities during cardiac monitoring ^[34]

End point description

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. Only those participants with data available at the specified time point was analyzed.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	5 ^[35]	1 ^[36]
Units: Participants
Abnormal-Clinically significant	2	0
Abnormal-Not Clinically significant	3	1

Notes
[35] - Safety Population
[36] - Safety Population

No statistical analyses for this end point

Primary: Number of participants for which unscheduled echocardiography (ECHO) was performed for safety reasons

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End point title

Number of participants for which unscheduled echocardiography (ECHO) was performed for safety reasons ^[37]

End point description

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. Only those participants with data available at the specified time point was analyzed.

End point type

Primary

End point timeframe

Up to the end of study (Up to 369 days)

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	2 ^[38]	0 ^[39]
Units: Participants	2

Notes
[38] - Safety Population
[39] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with skin rashes

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End point title

Number of participants with skin rashes ^[40]

End point description

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.

End point type

Primary

End point timeframe

Up to 56 days after the last dosing session (up to 265 days)

Notes
[40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[41]	1 ^[42]
Units: Participants	4	0

Notes
[41] - Safety Population
[42] - Safety Population

No statistical analyses for this end point

Primary: Number of participants with skin rashes classified using CTCAE

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End point title

Number of participants with skin rashes classified using CTCAE ^[43]

End point description

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 categorized as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.

End point type

Primary

End point timeframe

Up to 56 days after the last dosing session (up to 265 days)

Notes
[43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There are no statistical data to report.

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	4 ^[44]	0 ^[45]
Units: Participants
Grade 1	3
Grade 2	1
Grade 3	0
Grade 4	0
Grade 5	0

Notes
[44] - Safety Population
[45] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormalities in histopathological examination of skin biopsies

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End point title

Number of participants with abnormalities in histopathological examination of skin biopsies

End point description

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.

End point type

Secondary

End point timeframe

Up to the end of study (Up to 369 days)

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[46]	1 ^[47]
Units: Participants	2	0

Notes
[46] - Safety Population
[47] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormalities in immunohistochemical examination of skin biopsies

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End point title

Number of participants with abnormalities in immunohistochemical examination of skin biopsies

End point description

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.

End point type

Secondary

End point timeframe

Up to the end of study (Up to 369 days)

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[48]	1 ^[49]
Units: Participants	2	1

Notes
[48] - Safety Population
[49] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormalities in histopathological examination of blood biomarkers

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End point title

Number of participants with abnormalities in histopathological examination of blood biomarkers

End point description

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. Data was not collected due to project termination.

End point type

Secondary

End point timeframe

Up to the end of study (Up to 369 days)

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	0 ^[50]	0 ^[51]
Units: Participants

Notes
[50] - Safety Population
[51] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with abnormalities in immunohistochemical examination of blood biomarkers

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End point title

Number of participants with abnormalities in immunohistochemical examination of blood biomarkers

End point description

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. Data was not collected due to project termination.

End point type

Secondary

End point timeframe

Up to the end of study (Up to 369 days)

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	0 ^[52]	0 ^[53]
Units: Participants

Notes
[52] - Safety Population
[53] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 3 (C3) over time

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End point title

Change from Baseline in Fluid Phase Complement Marker-Complement 3 (C3) over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 6

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[54]	1 ^[55]
Units: Grams per Liter (g/L)
arithmetic mean (standard deviation)
C3, Session 1, Day 1, predose, n=6,1	-0.032 ( 0.1444 )	-0.150 ( 88888 )
C3, Session 1, Day 1, 2 hour, n=6,1	-0.008 ( 0.1105 )	-0.230 ( 88888 )
C3, Session 1, Day 1, 4 hour, n=6,1	0.030 ( 0.0566 )	-0.100 ( 88888 )
C3, Session 1, Day 1, 8 hour, n=6,1	0.068 ( 0.2073 )	-0.160 ( 88888 )
C3, Session 1, Day 2, n=6,1	-0.125 ( 0.1033 )	-0.180 ( 88888 )
C3, Session 1, Day 3, predose, n=6,1	-0.198 ( 0.1607 )	-0.200 ( 88888 )
C3, Session 1, Day 3, 2 hour, n=6,0	-0.188 ( 0.1572 )	99999 ( 99999 )
C3, Session 1, Day 3, 4 hour, n=6,0	-0.222 ( 0.1288 )	99999 ( 99999 )
C3, Session 1, Day 3, 8 hour, n=6,0	-0.155 ( 0.1590 )	99999 ( 99999 )
C3, Session 1, Day 5, n=6,0	-0.280 ( 0.1646 )	99999 ( 99999 )
C3, Session 1, Day 6, n=6,0	-0.338 ( 0.1969 )	99999 ( 99999 )
C3, Session 2, Day 1, predose, n=6,0	-0.067 ( 0.1999 )	99999 ( 99999 )
C3, Session 2, Day 1, 2 hour, n=6,0	-0.103 ( 0.1629 )	99999 ( 99999 )
C3, Session 2, Day 1, 4 hour, n=6,0	-0.075 ( 0.2017 )	99999 ( 99999 )
C3, Session 2, Day 1, 8 hour, n=6,0	-0.130 ( 0.1585 )	99999 ( 99999 )
C3, Session 2, Day 2, n=6,0	-0.153 ( 0.1485 )	99999 ( 99999 )
C3, Session 2, Day 3, predose, n=6,0	-0.263 ( 0.1385 )	99999 ( 99999 )
C3, Session 2, Day 3, 2 hour, n=6,0	-0.242 ( 0.1694 )	99999 ( 99999 )
C3, Session 2, Day 3, 4 hour, n=6,0	-0.243 ( 0.1994 )	99999 ( 99999 )
C3, Session 2, Day 3, 8 hour, n=6,0	-0.235 ( 0.1685 )	99999 ( 99999 )
C3, Session 2, Day 5, n=6,0	-0.280 ( 0.1716 )	99999 ( 99999 )
C3, Session 2, Day 6, n=6,0	-0.327 ( 0.2298 )	99999 ( 99999 )
C3, Session 3, Day 1, predose, n=6,0	-0.053 ( 0.1928 )	99999 ( 99999 )
C3, Session 3, Day 1, 2 hour, n=6,0	-0.078 ( 0.2279 )	99999 ( 99999 )
C3, Session 3, Day 1, 4 hour, n=6,0	-0.058 ( 0.2299 )	99999 ( 99999 )
C3, Session 3, Day 1, 8 hour, n=6,0	-0.057 ( 0.1999 )	99999 ( 99999 )
C3, Session 3, Day 2, n=5,0	-0.084 ( 0.2792 )	99999 ( 99999 )
C3, Session 3, Day 3, predose, n=6,0	-0.215 ( 0.1576 )	99999 ( 99999 )
C3, Session 3, Day 3, 2 hour, n=6,0	-0.232 ( 0.1699 )	99999 ( 99999 )
C3, Session 3, Day 3, 4 hour, n=6,0	-0.200 ( 0.1808 )	99999 ( 99999 )
C3, Session 3, Day 3, 8 hour, n=6,0	-0.190 ( 0.2287 )	99999 ( 99999 )
C3, Session 3, Day 5, n=6,0	-0.290 ( 0.1719 )	99999 ( 99999 )
C3, Session 3, Day 6, n=6,0	-0.308 ( 0.2077 )	99999 ( 99999 )
C3, Session 4, Day 1, predose, n=5,0	-0.094 ( 0.2271 )	99999 ( 99999 )
C3, Session 4, Day 1, 2 hour, n=5,0	-0.088 ( 0.1993 )	99999 ( 99999 )
C3, Session 4, Day 1, 4 hour, n=4,0	-0.005 ( 0.1392 )	99999 ( 99999 )
C3, Session 4, Day 1, 8 hour, n=5,0	-0.124 ( 0.1747 )	99999 ( 99999 )
C3, Session 4, Day 2, n=5,0	-0.144 ( 0.1641 )	99999 ( 99999 )
C3, Session 4, Day 3, predose, n=5,0	-0.214 ( 0.2454 )	99999 ( 99999 )
C3, Session 4, Day 3, 2 hour, n=5,0	-0.204 ( 0.2306 )	99999 ( 99999 )
C3, Session 4, Day 3, 4 hour, n=5,0	-0.190 ( 0.2088 )	99999 ( 99999 )
C3, Session 4, Day 3, 8 hour, n=5,0	-0.188 ( 0.2305 )	99999 ( 99999 )
C3, Session 4, Day 5, n=5,0	-0.270 ( 0.1996 )	99999 ( 99999 )
C3, Session 4, Day 6, n=5,0	-0.302 ( 0.2251 )	99999 ( 99999 )
C3, Session 5, Day 1, predose, n=4,0	-0.173 ( 0.1863 )	99999 ( 99999 )
C3, Session 5, Day 1, 2 hour, n=4,0	-0.147 ( 0.2326 )	99999 ( 99999 )
C3, Session 5, Day 1, 4 hour, n=4,0	-0.125 ( 0.1741 )	99999 ( 99999 )
C3, Session 5, Day 1, 8 hour, n=4,0	-0.150 ( 0.1881 )	99999 ( 99999 )
C3, Session 5, Day 2, n=4,0	-0.178 ( 0.2340 )	99999 ( 99999 )
C3, Session 5, Day 3, predose, n=4,0	-0.248 ( 0.1919 )	99999 ( 99999 )
C3, Session 5, Day 3, 2 hour, n=4,0	-0.235 ( 0.1964 )	99999 ( 99999 )
C3, Session 5, Day 3, 4 hour, n=4,0	-0.280 ( 0.2045 )	99999 ( 99999 )
C3, Session 5, Day 3, 8 hour, n=4,0	-0.235 ( 0.2301 )	99999 ( 99999 )
C3, Session 5, Day 5, n=4,0	-0.258 ( 0.2035 )	99999 ( 99999 )
C3, Session 5, Day 6, n=4,0	-0.288 ( 0.1941 )	99999 ( 99999 )
C3, Session 6, Day 1, predose, n=4,0	-0.152 ( 0.2144 )	99999 ( 99999 )
C3, Session 6, Day 1, 2 hour, n=4,0	-0.145 ( 0.1877 )	99999 ( 99999 )
C3, Session 6, Day 1, 4 hour, n=4,0	-0.145 ( 0.2528 )	99999 ( 99999 )
C3, Session 6, Day 1, 8 hour, n=4,0	-0.135 ( 0.2626 )	99999 ( 99999 )
C3, Session 6, Day 2, n=4,0	-0.203 ( 0.2090 )	99999 ( 99999 )
C3, Session 6, Day 3, predose, n=4,0	-0.215 ( 0.2319 )	99999 ( 99999 )
C3, Session 6, Day 3, 2 hour, n=4,0	-0.273 ( 0.2179 )	99999 ( 99999 )
C3, Session 6, Day 3, 4 hour, n=4,0	-0.235 ( 0.2243 )	99999 ( 99999 )
C3, Session 6, Day 3, 8 hour, n=4,0	-0.238 ( 0.2421 )	99999 ( 99999 )
C3, Session 6, Day 5, n=4,0	-0.288 ( 0.2269 )	99999 ( 99999 )
C3, Session 6, Day 6, n=4,0	-0.315 ( 0.2225 )	99999 ( 99999 )

Notes
[54] - Safety Population
[55] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 4 (C4) over time

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End point title

Change from Baseline in Fluid Phase Complement Marker-Complement 4 (C4) over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Day 2, Day 5, Day 6

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[56]	1 ^[57]
Units: Grams per Liter (g/L)
arithmetic mean (standard deviation)
C4, Session 1, Day 2, n=6,1	-0.015 ( 0.0373 )	0.000 ( 88888 )
C4, Session 1, Day 5, n=6,0	-0.013 ( 0.0393 )	99999 ( 99999 )
C4, Session 1, Day 6, n=6,0	-0.017 ( 0.0403 )	99999 ( 99999 )
C4, Session 2, Day 2, n=6,0	-0.027 ( 0.0423 )	99999 ( 99999 )
C4, Session 2, Day 5, n=6,0	-0.023 ( 0.0505 )	99999 ( 99999 )
C4, Session 2, Day 6, n=6,0	-0.030 ( 0.0540 )	99999 ( 99999 )
C4, Session 3, Day 2, n=5,0	-0.010 ( 0.0543 )	99999 ( 99999 )
C4, Session 3, Day 5, n=6,0	-0.042 ( 0.0449 )	99999 ( 99999 )
C4, Session 3, Day 6, n=6,0	-0.042 ( 0.0542 )	99999 ( 99999 )
C4, Session 4, Day 2, n=5,0	-0.022 ( 0.0531 )	99999 ( 99999 )
C4, Session 4, Day 5, n=5,0	-0.036 ( 0.0677 )	99999 ( 99999 )
C4, Session 4, Day 6, n=5,0	-0.042 ( 0.0507 )	99999 ( 99999 )
C4, Session 5, Day 2, n=4,0	-0.028 ( 0.0574 )	99999 ( 99999 )
C4, Session 5, Day 5, n=4,0	-0.033 ( 0.0574 )	99999 ( 99999 )
C4, Session 5, Day 6, n=4,0	-0.025 ( 0.0545 )	99999 ( 99999 )
C4, Session 6, Day 2, n=4,0	-0.043 ( 0.0544 )	99999 ( 99999 )
C4, Session 6, Day 5, n=4,0	-0.050 ( 0.0678 )	99999 ( 99999 )
C4, Session 6, Day 6, n=4,0	-0.045 ( 0.0666 )	99999 ( 99999 )

Notes
[56] - Safety Population
[57] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Fluid Phase Complement Marker-Total Complement (CH50) over time

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End point title

Change from Baseline in Fluid Phase Complement Marker-Total Complement (CH50) over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 6

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[58]	1 ^[59]
Units: Units per milliliter
arithmetic mean (standard deviation)
CH50, Session 1, Day 1, predose, n=6,1	-0.7 ( 1.37 )	0.0 ( 88888 )
CH50, Session 1, Day 1, 2 hour, n=6,1	-0.8 ( 1.33 )	0.0 ( 88888 )
CH50, Session 1, Day 1, 4 hour, n=6,1	0.2 ( 0.41 )	0.0 ( 88888 )
CH50, Session 1, Day 1, 8 hour, n=6,1	-0.8 ( 1.60 )	0.0 ( 88888 )
CH50, Session 1, Day 2, n=6,1	-2.7 ( 3.20 )	0.0 ( 88888 )
CH50, Session 1, Day 3, predose, n=6,1	-3.3 ( 4.46 )	0.0 ( 88888 )
CH50, Session 1, Day 3, 2 hour, n=6,0	-3.3 ( 4.37 )	99999 ( 99999 )
CH50, Session 1, Day 3, 4 hour, n=6,0	-2.5 ( 3.78 )	99999 ( 99999 )
CH50, Session 1, Day 3, 8 hour, n=6,0	-2.2 ( 3.25 )	99999 ( 99999 )
CH50, Session 1, Day 5, n=6,0	-4.7 ( 5.01 )	99999 ( 99999 )
CH50, Session 1, Day 6, n=6,0	-7.3 ( 6.19 )	99999 ( 99999 )
CH50, Session 2, Day 1, predose, n=6,0	-1.7 ( 3.67 )	99999 ( 99999 )
CH50, Session 2, Day 1, 2 hour, n=6,0	-2.3 ( 4.84 )	99999 ( 99999 )
CH50, Session 2, Day 1, 4 hour, n=6,0	-2.3 ( 4.63 )	99999 ( 99999 )
CH50, Session 2, Day 1, 8 hour, n=6,0	-3.5 ( 7.84 )	99999 ( 99999 )
CH50, Session 2, Day 2, n=6,0	-4.3 ( 6.02 )	99999 ( 99999 )
CH50, Session 2, Day 3, predose, n=6,0	-4.5 ( 6.16 )	99999 ( 99999 )
CH50, Session 2, Day 3, 2 hour, n=6,0	-4.0 ( 5.55 )	99999 ( 99999 )
CH50, Session 2, Day 3, 4 hour, n=6,0	-3.8 ( 6.31 )	99999 ( 99999 )
CH50, Session 2, Day 3, 8 hour, n=6,0	-3.8 ( 3.92 )	99999 ( 99999 )
CH50, Session 2, Day 5, n=6,0	-5.2 ( 6.31 )	99999 ( 99999 )
CH50, Session 2, Day 6, n=6,0	-8.5 ( 9.61 )	99999 ( 99999 )
CH50, Session 3, Day 1, predose, n=6,0	-4.5 ( 7.94 )	99999 ( 99999 )
CH50, Session 3, Day 1, 2 hour, n=6,0	-4.2 ( 7.44 )	99999 ( 99999 )
CH50, Session 3, Day 1, 4 hour, n=6,0	-4.5 ( 7.79 )	99999 ( 99999 )
CH50, Session 3, Day 1, 8 hour, n=6,0	-4.8 ( 8.35 )	99999 ( 99999 )
CH50, Session 3, Day 2, n=5,0	-3.6 ( 8.68 )	99999 ( 99999 )
CH50, Session 3, Day 3, predose, n=6,0	-5.2 ( 8.86 )	99999 ( 99999 )
CH50, Session 3, Day 3, 2 hour, n=6,0	-5.2 ( 8.86 )	99999 ( 99999 )
CH50, Session 3, Day 3, 4 hour, n=6,0	-5.3 ( 8.57 )	99999 ( 99999 )
CH50, Session 3, Day 3, 8 hour, n=6,0	-6.8 ( 10.05 )	99999 ( 99999 )
CH50, Session 3, Day 5, n=6,0	-7.0 ( 10.28 )	99999 ( 99999 )
CH50, Session 3, Day 6, n=6,0	-8.2 ( 11.02 )	99999 ( 99999 )
CH50, Session 4, Day 1, predose, n=5,0	-3.0 ( 5.20 )	99999 ( 99999 )
CH50, Session 4, Day 1, 2 hour, n=5,0	-2.0 ( 3.94 )	99999 ( 99999 )
CH50, Session 4, Day 1, 4 hour, n=5,0	-1.6 ( 4.77 )	99999 ( 99999 )
CH50, Session 4, Day 1, 8 hour, n=5,0	-1.6 ( 3.21 )	99999 ( 99999 )
CH50, Session 4, Day 2, n=5,0	-1.6 ( 3.13 )	99999 ( 99999 )
CH50, Session 4, Day 3, predose, n=5,0	-5.0 ( 6.08 )	99999 ( 99999 )
CH50, Session 4, Day 3, 2 hour, n=5,0	-3.2 ( 4.09 )	99999 ( 99999 )
CH50, Session 4, Day 3, 4 hour, n=5,0	-3.0 ( 6.40 )	99999 ( 99999 )
CH50, Session 4, Day 3, 8 hour, n=5,0	-4.0 ( 6.04 )	99999 ( 99999 )
CH50, Session 4, Day 5, n=5,0	-5.6 ( 7.70 )	99999 ( 99999 )
CH50, Session 4, Day 6, n=5,0	-6.6 ( 7.83 )	99999 ( 99999 )
CH50, Session 5, Day 1, predose, n=4,0	-3.8 ( 5.91 )	99999 ( 99999 )
CH50, Session 5, Day 1, 2 hour, n=4,0	-3.0 ( 5.72 )	99999 ( 99999 )
CH50, Session 5, Day 1, 4 hour, n=4,0	-2.8 ( 6.29 )	99999 ( 99999 )
CH50, Session 5, Day 1, 8 hour, n=4,0	-3.0 ( 5.29 )	99999 ( 99999 )
CH50, Session 5, Day 2, n=4,0	-3.5 ( 5.32 )	99999 ( 99999 )
CH50, Session 5, Day 3, predose, n=4,0	-5.0 ( 5.77 )	99999 ( 99999 )
CH50, Session 5, Day 3, 2 hour, n=4,0	-4.8 ( 6.80 )	99999 ( 99999 )
CH50, Session 5, Day 3, 4 hour, n=4,0	-4.8 ( 6.70 )	99999 ( 99999 )
CH50, Session 5, Day 3, 8 hour, n=4,0	-4.8 ( 6.80 )	99999 ( 99999 )
CH50, Session 5, Day 5, n=4,0	-5.5 ( 7.72 )	99999 ( 99999 )
CH50, Session 5, Day 6, n=4,0	-5.3 ( 8.54 )	99999 ( 99999 )
CH50, Session 6, Day 1, predose, n=4,0	-2.3 ( 4.03 )	99999 ( 99999 )
CH50, Session 6, Day 1, 2 hour, n=4,0	-2.8 ( 6.90 )	99999 ( 99999 )
CH50, Session 6, Day 1, 4 hour, n=4,0	-3.3 ( 7.27 )	99999 ( 99999 )
CH50, Session 6, Day 1, 8 hour, n=4,0	-3.5 ( 6.66 )	99999 ( 99999 )
CH50, Session 6, Day 2, n=4,0	-4.3 ( 6.13 )	99999 ( 99999 )
CH50, Session 6, Day 3, predose, n=4,0	-5.0 ( 8.52 )	99999 ( 99999 )
CH50, Session 6, Day 3, 2 hour, n=4,0	-4.8 ( 8.54 )	99999 ( 99999 )
CH50, Session 6, Day 3, 4 hour, n=4,0	-4.3 ( 8.66 )	99999 ( 99999 )
CH50, Session 6, Day 3, 8 hour, n=4,0	-5.0 ( 8.52 )	99999 ( 99999 )
CH50, Session 6, Day 5, n=4,0	-5.3 ( 9.00 )	99999 ( 99999 )
CH50, Session 6, Day 6, n=4,0	-5.5 ( 9.47 )	99999 ( 99999 )

Notes
[58] - Safety Population
[59] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in inflammatory biomarkers over time

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End point title

Change from Baseline in inflammatory biomarkers over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 6

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[60]	1 ^[61]
Units: Milligrams per Liter (mg/L)
arithmetic mean (standard deviation)
CRP, Session 1, Day 1, predose, n=5,1	-0.12 ( 0.572 )	-4.60 ( 88888 )
CRP, Session 1, Day 1, 2 hour, n=5,1	-0.26 ( 0.573 )	-4.80 ( 88888 )
CRP, Session 1, Day 1, 4 hour, n=4,1	-0.28 ( 0.486 )	-4.70 ( 88888 )
CRP, Session 1, Day 1, 8 hour, n=5,1	-0.18 ( 0.634 )	-4.60 ( 88888 )
CRP, Session 1, Day 2, n=5,1	0.64 ( 1.701 )	44.70 ( 88888 )
CRP, Session 1, Day 3, predose, n=5,1	14.08 ( 12.511 )	131.20 ( 88888 )
CRP, Session 1, Day 3, 2 hour, n=5,0	14.52 ( 13.128 )	99999 ( 99999 )
CRP, Session 1, Day 3, 4 hour, n=5,0	15.30 ( 13.119 )	99999 ( 99999 )
CRP, Session 1, Day 3, 8 hour, n=5,0	17.64 ( 14.527 )	99999 ( 99999 )
CRP, Session 1, Day 5, n=5,0	17.20 ( 14.772 )	99999 ( 99999 )
CRP, Session 1, Day 6, n=5,0	19.52 ( 15.665 )	99999 ( 99999 )
CRP, Session 2, Day 1, predose, n=5,0	2.24 ( 2.864 )	99999 ( 99999 )
CRP, Session 2, Day 1, 2 hour, n=5,0	2.12 ( 2.613 )	99999 ( 99999 )
CRP, Session 2, Day 1, 4 hour, n=5,0	2.18 ( 2.710 )	99999 ( 99999 )
CRP, Session 2, Day 1, 8 hour, n=5,0	2.18 ( 2.658 )	99999 ( 99999 )
CRP, Session 2, Day 2, n=4,0	2.00 ( 2.624 )	99999 ( 99999 )
CRP, Session 2, Day 3, predose, n=5,0	27.42 ( 26.283 )	99999 ( 99999 )
CRP, Session 2, Day 3, 2 hour, n=5,0	29.46 ( 27.415 )	99999 ( 99999 )
CRP, Session 2, Day 3, 4 hour, n=5,0	30.90 ( 27.961 )	99999 ( 99999 )
CRP, Session 2, Day 3, 8 hour, n=5,0	31.76 ( 27.897 )	99999 ( 99999 )
CRP, Session 2, Day 5, n=4,0	28.33 ( 22.386 )	99999 ( 99999 )
CRP, Session 2, Day 6, n=5,0	27.04 ( 18.632 )	99999 ( 99999 )
CRP, Session 3, Day 1, predose, n=4,0	1.93 ( 2.343 )	99999 ( 99999 )
CRP, Session 3, Day 1, 2 hour, n=4,0	2.05 ( 2.626 )	99999 ( 99999 )
CRP, Session 3, Day 1, 4 hour, n=4,0	2.15 ( 2.891 )	99999 ( 99999 )
CRP, Session 3, Day 1, 8 hour, n=4,0	2.15 ( 2.760 )	99999 ( 99999 )
CRP, Session 3, Day 2, n=4,0	1.75 ( 2.161 )	99999 ( 99999 )
CRP, Session 3, Day 3, predose, n=4,0	18.13 ( 15.476 )	99999 ( 99999 )
CRP, Session 3, Day 3, 2 hour, n=4,0	19.40 ( 16.403 )	99999 ( 99999 )
CRP, Session 3, Day 3, 4 hour, n=4,0	21.20 ( 17.827 )	99999 ( 99999 )
CRP, Session 3, Day 3, 8 hour, n=4,0	22.63 ( 18.466 )	99999 ( 99999 )
CRP, Session 3, Day 5, n=5,0	19.00 ( 15.625 )	99999 ( 99999 )
CRP, Session 3, Day 6, n=4,0	24.10 ( 16.785 )	99999 ( 99999 )
CRP, Session 4, Day 1, predose, n=4,0	2.33 ( 4.487 )	99999 ( 99999 )
CRP, Session 4, Day 1, 2 hour, n=4,0	2.53 ( 4.762 )	99999 ( 99999 )
CRP, Session 4, Day 1, 4 hour, n=4,0	2.45 ( 4.669 )	99999 ( 99999 )
CRP, Session 4, Day 1, 8 hour, n=4,0	2.40 ( 4.455 )	99999 ( 99999 )
CRP, Session 4, Day 2, n=4,0	2.23 ( 3.963 )	99999 ( 99999 )
CRP, Session 4, Day 3, predose, n=4,0	12.45 ( 13.533 )	99999 ( 99999 )
CRP, Session 4, Day 3, 2 hour, n=4,0	14.75 ( 16.539 )	99999 ( 99999 )
CRP, Session 4, Day 3, 4 hour, n=4,0	16.75 ( 19.129 )	99999 ( 99999 )
CRP, Session 4, Day 3, 8 hour, n=4,0	17.30 ( 17.830 )	99999 ( 99999 )
CRP, Session 4, Day 5, n=4,0	18.43 ( 9.959 )	99999 ( 99999 )
CRP, Session 4, Day 6, n=4,0	19.98 ( 11.277 )	99999 ( 99999 )
CRP, Session 5, Day 1, predose, n=3,0	2.23 ( 3.439 )	99999 ( 99999 )
CRP, Session 5, Day 1, 2 hour, n=3,0	2.13 ( 3.350 )	99999 ( 99999 )
CRP, Session 5, Day 1, 4 hour, n=3,0	1.97 ( 3.147 )	99999 ( 99999 )
CRP, Session 5, Day 1, 8 hour, n=3,0	2.10 ( 3.378 )	99999 ( 99999 )
CRP, Session 5, Day 2, n=3,0	1.37 ( 2.811 )	99999 ( 99999 )
CRP, Session 5, Day 3, predose, n=3,0	8.33 ( 11.517 )	99999 ( 99999 )
CRP, Session 5, Day 3, 2 hour, n=3,0	9.87 ( 12.881 )	99999 ( 99999 )
CRP, Session 5, Day 3, 4 hour, n=3,0	10.47 ( 12.874 )	99999 ( 99999 )
CRP, Session 5, Day 3, 8 hour, n=3,0	12.90 ( 14.944 )	99999 ( 99999 )
CRP, Session 5, Day 5, n=2,0	34.30 ( 40.588 )	99999 ( 99999 )
CRP, Session 5, Day 6, n=2,0	35.20 ( 34.931 )	99999 ( 99999 )
CRP, Session 6, Day 1, predose, n=3,0	4.00 ( 3.851 )	99999 ( 99999 )
CRP, Session 6, Day 1, 2 hour, n=3,0	3.63 ( 3.711 )	99999 ( 99999 )
CRP, Session 6, Day 1, 4 hour, n=3,0	3.70 ( 3.835 )	99999 ( 99999 )
CRP, Session 6, Day 1, 8 hour, n=3,0	3.70 ( 3.874 )	99999 ( 99999 )
CRP, Session 6, Day 2, n=3,0	2.63 ( 2.914 )	99999 ( 99999 )
CRP, Session 6, Day 3, predose, n=3,0	9.17 ( 8.879 )	99999 ( 99999 )
CRP, Session 6, Day 3, 2 hour, n=3,0	11.10 ( 10.887 )	99999 ( 99999 )
CRP, Session 6, Day 3, 4 hour, n=3,0	12.70 ( 11.555 )	99999 ( 99999 )
CRP, Session 6, Day 3, 8 hour, n=3,0	14.67 ( 12.580 )	99999 ( 99999 )
CRP, Session 6, Day 5, n=3,0	14.10 ( 7.146 )	99999 ( 99999 )
CRP, Session 6, Day 6, n=3,0	17.33 ( 7.844 )	99999 ( 99999 )
hsCRP, Session 1, Day 1, predose, n=5,1	-0.08 ( 0.356 )	-3.60 ( 88888 )
hsCRP, Session 1, Day 1, 2 hour, n=5,1	-0.08 ( 0.327 )	-3.70 ( 88888 )
hsCRP, Session 1, Day 1, 4 hour, n=4,1	-0.20 ( 0.271 )	-3.70 ( 88888 )
hsCRP, Session 1, Day 1, 8 hour, n=5,1	-0.10 ( 0.406 )	-3.60 ( 88888 )
hsCRP, Session 1, Day 2, n=5,1	0.56 ( 1.286 )	41.40 ( 88888 )
hsCRP, Session 1, Day 3, predose, n=5,1	14.54 ( 13.149 )	135.20 ( 88888 )
hsCRP, Session 1, Day 3, 2 hour, n=5,0	15.14 ( 13.363 )	99999 ( 99999 )
hsCRP, Session 1, Day 3, 4 hour, n=5,0	15.84 ( 13.607 )	99999 ( 99999 )
hsCRP, Session 1, Day 3, 8 hour, n=5,0	17.10 ( 14.294 )	99999 ( 99999 )
hsCRP, Session 1, Day 5, n=5,0	16.70 ( 14.332 )	99999 ( 99999 )
hsCRP, Session 1, Day 6, n=5,0	18.60 ( 14.778 )	99999 ( 99999 )
hsCRP, Session 2, Day 1, predose, n=5,0	1.88 ( 2.539 )	99999 ( 99999 )
hsCRP, Session 2, Day 1, 2 hour, n=5,0	1.78 ( 2.351 )	99999 ( 99999 )
hsCRP, Session 2, Day 1, 4 hour, n=5,0	1.90 ( 2.478 )	99999 ( 99999 )
hsCRP, Session 2, Day 1, 8 hour, n=5,0	1.78 ( 2.179 )	99999 ( 99999 )
hsCRP, Session 2, Day 2, n=4,0	1.75 ( 2.266 )	99999 ( 99999 )
hsCRP, Session 2, Day 3, predose, n=5,0	26.76 ( 26.122 )	99999 ( 99999 )
hsCRP, Session 2, Day 3, 2 hour, n=5,0	29.28 ( 27.373 )	99999 ( 99999 )
hsCRP, Session 2, Day 3, 4 hour, n=5,0	30.36 ( 27.018 )	99999 ( 99999 )
hsCRP, Session 2, Day 3, 8 hour, n=5,0	31.10 ( 26.885 )	99999 ( 99999 )
hsCRP, Session 2, Day 5, n=4,0	28.13 ( 21.919 )	99999 ( 99999 )
hsCRP, Session 2, Day 6, n=5,0	27.20 ( 18.468 )	99999 ( 99999 )
hsCRP, Session 3, Day 1, predose, n=4,0	1.60 ( 2.017 )	99999 ( 99999 )
hsCRP, Session 3, Day 1, 2 hour, n=4,0	1.63 ( 2.175 )	99999 ( 99999 )
hsCRP, Session 3, Day 1, 4 hour, n=4,0	1.70 ( 2.403 )	99999 ( 99999 )
hsCRP, Session 3, Day 1, 8 hour, n=4,0	1.65 ( 2.161 )	99999 ( 99999 )
hsCRP, Session 3, Day 2, n=4,0	1.25 ( 1.754 )	99999 ( 99999 )
hsCRP, Session 3, Day 3, predose, n=4,0	17.88 ( 15.954 )	99999 ( 99999 )
hsCRP, Session 3, Day 3, 2 hour, n=4,0	19.23 ( 16.675 )	99999 ( 99999 )
hsCRP, Session 3, Day 3, 4 hour, n=4,0	20.58 ( 17.733 )	99999 ( 99999 )
hsCRP, Session 3, Day 3, 8 hour, n=4,0	22.10 ( 18.149 )	99999 ( 99999 )
hsCRP, Session 3, Day 5, n=4,0	22.45 ( 15.042 )	99999 ( 99999 )
hsCRP, Session 3, Day 6, n=4,0	23.73 ( 16.141 )	99999 ( 99999 )
hsCRP, Session 4, Day 1, predose, n=4,0	2.28 ( 4.043 )	99999 ( 99999 )
hsCRP, Session 4, Day 1, 2 hour, n=4,0	2.53 ( 4.610 )	99999 ( 99999 )
hsCRP, Session 4, Day 1, 4 hour, n=4,0	2.53 ( 4.479 )	99999 ( 99999 )
hsCRP, Session 4, Day 1, 8 hour, n=4,0	2.58 ( 4.528 )	99999 ( 99999 )
hsCRP, Session 4, Day 2, n=4,0	2.20 ( 3.558 )	99999 ( 99999 )
hsCRP, Session 4, Day 3, predose, n=4,0	12.33 ( 13.881 )	99999 ( 99999 )
hsCRP, Session 4, Day 3, 2 hour, n=4,0	14.40 ( 16.324 )	99999 ( 99999 )
hsCRP, Session 4, Day 3, 4 hour, n=4,0	16.00 ( 18.240 )	99999 ( 99999 )
hsCRP, Session 4, Day 3, 8 hour, n=4,0	17.08 ( 17.972 )	99999 ( 99999 )
hsCRP, Session 4, Day 5, n=4,0	19.60 ( 10.903 )	99999 ( 99999 )
hsCRP, Session 4, Day 6, n=4,0	20.73 ( 11.391 )	99999 ( 99999 )
hsCRP, Session 5, Day 1, predose, n=3,0	2.03 ( 3.349 )	99999 ( 99999 )
hsCRP, Session 5, Day 1, 2 hour, n=3,0	1.97 ( 3.320 )	99999 ( 99999 )
hsCRP, Session 5, Day 1, 4 hour, n=3,0	1.83 ( 3.175 )	99999 ( 99999 )
hsCRP, Session 5, Day 1, 8 hour, n=3,0	1.87 ( 3.323 )	99999 ( 99999 )
hsCRP, Session 5, Day 2, n=3,0	1.23 ( 2.574 )	99999 ( 99999 )
hsCRP, Session 5, Day 3, predose, n=3,0	9.10 ( 13.182 )	99999 ( 99999 )
hsCRP, Session 5, Day 3, 2 hour, n=3,0	10.43 ( 14.629 )	99999 ( 99999 )
hsCRP, Session 5, Day 3, 4 hour, n=3,0	11.17 ( 14.865 )	99999 ( 99999 )
hsCRP, Session 5, Day 3, 8 hour, n=3,0	12.67 ( 15.557 )	99999 ( 99999 )
hsCRP, Session 5, Day 5, n=2,0	33.95 ( 40.941 )	99999 ( 99999 )
hsCRP, Session 5, Day 6, n=2,0	34.80 ( 34.083 )	99999 ( 99999 )
hsCRP, Session 6, Day 1, predose, n=3,0	3.77 ( 3.853 )	99999 ( 99999 )
hsCRP, Session 6, Day 1, 2 hour, n=3,0	3.37 ( 3.523 )	99999 ( 99999 )
hsCRP, Session 6, Day 1, 4 hour, n=3,0	3.50 ( 3.799 )	99999 ( 99999 )
hsCRP, Session 6, Day 1, 8 hour, n=3,0	3.27 ( 3.584 )	99999 ( 99999 )
hsCRP, Session 6, Day 2, n=3,0	2.33 ( 2.775 )	99999 ( 99999 )
hsCRP, Session 6, Day 3, predose, n=3,0	8.97 ( 9.752 )	99999 ( 99999 )
hsCRP, Session 6, Day 3, 2 hour, n=3,0	10.57 ( 11.075 )	99999 ( 99999 )
hsCRP, Session 6, Day 3, 4 hour, n=3,0	12.60 ( 12.322 )	99999 ( 99999 )
hsCRP, Session 6, Day 3, 8 hour, n=3,0	15.33 ( 14.276 )	99999 ( 99999 )
hsCRP, Session 6, Day 5, n=3,0	14.43 ( 7.801 )	99999 ( 99999 )
hsCRP, Session 6, Day 6, n=3,0	18.63 ( 8.607 )	99999 ( 99999 )
SAA, Session 1, Day 1, predose, n=5,1	0.2164 ( 1.55486 )	-22.3723 ( 88888 )
SAA, Session 1, Day 1, 2 hour, n=5,1	0.1738 ( 1.13909 )	-22.4187 ( 88888 )
SAA, Session 1, Day 1, 4 hour, n=5,1	0.3902 ( 1.56253 )	-21.7463 ( 88888 )
SAA, Session 1, Day 1, 8 hour, n=5,1	0.2695 ( 1.57992 )	-14.8767 ( 88888 )
SAA, Session 1, Day 2, n=5,1	2.9247 ( 3.47577 )	322.2895 ( 88888 )
SAA, Session 1, Day 3, predose, n=5,1	50.7137 ( 55.02969 )	1437.7667 ( 88888 )
SAA, Session 1, Day 3, 2 hour, n=5,0	54.8466 ( 59.36005 )	99999 ( 99999 )
SAA, Session 1, Day 3, 4 hour, n=5,0	54.9329 ( 55.92645 )	99999 ( 99999 )
SAA, Session 1, Day 3, 8 hour, n=5,0	68.4699 ( 75.51138 )	99999 ( 99999 )
SAA, Session 1, Day 5, n=5,0	54.6741 ( 69.66316 )	99999 ( 99999 )
SAA, Session 1, Day 6, n=5,0	55.2882 ( 63.77870 )	99999 ( 99999 )
SAA, Session 2, Day 1, predose, n=5,0	1.0277 ( 1.64965 )	99999 ( 99999 )
SAA, Session 2, Day 1, 2 hour, n=5,0	0.9841 ( 2.22042 )	99999 ( 99999 )
SAA, Session 2, Day 1, 4 hour, n=5,0	1.4543 ( 2.61184 )	99999 ( 99999 )
SAA, Session 2, Day 1, 8 hour, n=5,0	1.0588 ( 1.52455 )	99999 ( 99999 )
SAA, Session 2, Day 2, n=5,0	3.7244 ( 1.63856 )	99999 ( 99999 )
SAA, Session 2, Day 3, predose, n=5,0	134.4489 ( 160.14208 )	99999 ( 99999 )
SAA, Session 2, Day 3, 2 hour, n=5,0	145.2507 ( 171.92591 )	99999 ( 99999 )
SAA, Session 2, Day 3, 4 hour, n=5,0	142.5438 ( 174.11156 )	99999 ( 99999 )
SAA, Session 2, Day 3, 8 hour, n=5,0	100.8836 ( 184.35963 )	99999 ( 99999 )
SAA, Session 2, Day 5, n=5,0	76.8593 ( 136.83379 )	99999 ( 99999 )
SAA, Session 2, Day 6, n=5,0	101.0688 ( 105.88787 )	99999 ( 99999 )
SAA, Session 3, Day 1, predose, n=4,0	0.2428 ( 1.13002 )	99999 ( 99999 )
SAA, Session 3, Day 1, 2 hour, n=4,0	0.1863 ( 1.06333 )	99999 ( 99999 )
SAA, Session 3, Day 1, 4 hour, n=4,0	0.0475 ( 1.00422 )	99999 ( 99999 )
SAA, Session 3, Day 1, 8 hour, n=5,0	4.0339 ( 8.62955 )	99999 ( 99999 )
SAA, Session 3, Day 2, n=4,0	6.4822 ( 11.14119 )	99999 ( 99999 )
SAA, Session 3, Day 3, predose, n=5,0	54.7393 ( 82.22346 )	99999 ( 99999 )
SAA, Session 3, Day 3, 2 hour, n=5,0	58.0526 ( 83.12677 )	99999 ( 99999 )
SAA, Session 3, Day 3, 4 hour, n=5,0	64.1995 ( 93.61736 )	99999 ( 99999 )
SAA, Session 3, Day 3, 8 hour, n=5,0	66.9605 ( 93.98658 )	99999 ( 99999 )
SAA, Session 3, Day 5, n=5,0	58.6742 ( 50.93398 )	99999 ( 99999 )
SAA, Session 3, Day 6, n=5,0	49.4029 ( 46.30012 )	99999 ( 99999 )
SAA, Session 4, Day 1, predose, n=4,0	-0.1305 ( 1.86822 )	99999 ( 99999 )
SAA, Session 4, Day 1, 2 hour, n=4,0	0.0159 ( 1.91086 )	99999 ( 99999 )
SAA, Session 4, Day 1, 4 hour, n=4,0	-0.0013 ( 1.84104 )	99999 ( 99999 )
SAA, Session 4, Day 1, 8 hour, n=4,0	0.1997 ( 1.70496 )	99999 ( 99999 )
SAA, Session 4, Day 2, n=4,0	1.6015 ( 1.07082 )	99999 ( 99999 )
SAA, Session 4, Day 3, predose, n=4,0	45.1067 ( 82.67535 )	99999 ( 99999 )
SAA, Session 4, Day 3, 2 hour, n=4,0	51.0650 ( 94.33211 )	99999 ( 99999 )
SAA, Session 4, Day 3, 4 hour, n=4,0	55.0009 ( 101.37965 )	99999 ( 99999 )
SAA, Session 4, Day 3, 8 hour, n=4,0	55.7135 ( 101.39069 )	99999 ( 99999 )
SAA, Session 4, Day 5, n=4,0	51.2002 ( 54.84780 )	99999 ( 99999 )
SAA, Session 4, Day 6, n=4,0	41.2457 ( 38.77052 )	99999 ( 99999 )
SAA, Session 5, Day 1, predose, n=3,0	-0.1498 ( 1.04561 )	99999 ( 99999 )
SAA, Session 5, Day 1, 2 hour, n=3,0	-0.2399 ( 0.89843 )	99999 ( 99999 )
SAA, Session 5, Day 1, 4 hour, n=3,0	-0.1906 ( 0.94124 )	99999 ( 99999 )
SAA, Session 5, Day 1, 8 hour, n=3,0	-0.1771 ( 0.95814 )	99999 ( 99999 )
SAA, Session 5, Day 2, n=3,0	0.1380 ( 0.61958 )	99999 ( 99999 )
SAA, Session 5, Day 3, predose, n=3,0	10.8884 ( 17.72052 )	99999 ( 99999 )
SAA, Session 5, Day 3, 2 hour, n=3,0	8.6783 ( 11.48176 )	99999 ( 99999 )
SAA, Session 5, Day 3, 4 hour, n=3,0	9.2527 ( 11.23663 )	99999 ( 99999 )
SAA, Session 5, Day 3, 8 hour, n=3,0	13.7941 ( 19.39827 )	99999 ( 99999 )
SAA, Session 5, Day 5, n=3,0	66.2542 ( 107.98594 )	99999 ( 99999 )
SAA, Session 5, Day 6, n=3,0	73.0823 ( 118.07036 )	99999 ( 99999 )
SAA, Session 6, Day 1, predose, n=3,0	1.2964 ( 1.75482 )	99999 ( 99999 )
SAA, Session 6, Day 1, 2 hour, n=3,0	1.0538 ( 1.74392 )	99999 ( 99999 )
SAA, Session 6, Day 1, 4 hour, n=3,0	1.3139 ( 2.18542 )	99999 ( 99999 )
SAA, Session 6, Day 1, 8 hour, n=3,0	0.9078 ( 1.72500 )	99999 ( 99999 )
SAA, Session 6, Day 2, n=3,0	1.2641 ( 0.89837 )	99999 ( 99999 )
SAA, Session 6, Day 3, predose, n=3,0	7.4697 ( 5.41886 )	99999 ( 99999 )
SAA, Session 6, Day 3, 2 hour, n=3,0	8.3574 ( 4.40865 )	99999 ( 99999 )
SAA, Session 6, Day 3, 4 hour, n=3,0	11.0305 ( 8.80978 )	99999 ( 99999 )
SAA, Session 6, Day 3, 8 hour, n=3,0	14.5333 ( 12.26460 )	99999 ( 99999 )
SAA, Session 6, Day 5, n=3,0	25.2529 ( 27.55204 )	99999 ( 99999 )
SAA, Session 6, Day 6, n=3,0	32.6318 ( 41.82856 )	99999 ( 99999 )

Notes
[60] - Safety Population
[61] - Safety Population

No statistical analyses for this end point

Secondary: Maximum concentration (Cmax) of GSK2398852

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End point title

Maximum concentration (Cmax) of GSK2398852

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 11

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[62]	1 ^[63]
Units: Micrograms per milliliter (ug/mL)
geometric mean (geometric coefficient of variation)
Session 1, n=6,1	86.94 ( 31.58 )	88.64 ( 88888 )
Session 2, n=6,0	235.48 ( 25.22 )	99999 ( 99999 )
Session 3, n=6,0	222.23 ( 44.40 )	99999 ( 99999 )
Session 4, n=5,0	179.82 ( 33.87 )	99999 ( 99999 )
Session 5, n=4,0	185.52 ( 34.06 )	99999 ( 99999 )
Session 6, n=4,0	228.51 ( 49.73 )	99999 ( 99999 )

Notes
[62] - Safety Population
[63] - Safety Population

No statistical analyses for this end point

Secondary: Time associated with Cmax (Tmax) of GSK2398852

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End point title

Time associated with Cmax (Tmax) of GSK2398852

End point description

Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available.

End point type

Secondary

End point 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 11

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[64]	1 ^[65]
Units: Hour
median (full range (min-max))
Session 1, n=6,1	54.18 (53.9 to 54.9)	6.1 (6.1 to 6.1)
Session 2, n=6,0	54.07 (53.3 to 54.7)	99999 (-99999 to 99999)
Session 3, n=6,0	54.06 (12.1 to 55.8)	99999 (-99999 to 99999)
Session 4, n=5,0	54.50 (53.9 to 56.1)	99999 (-99999 to 99999)
Session 5, n=4,0	54.28 (6.1 to 56.1)	99999 (-99999 to 99999)
Session 6, n=4,0	54.18 (53.9 to 56.0)	99999 (-99999 to 99999)

Notes
[64] - Safety Population
[65] - Safety Population

No statistical analyses for this end point

Secondary: Area under the plasma concentration-time curve from time zero to time t (AUC 0-t) of GSK2398852

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End point title

Area under the plasma concentration-time curve from time zero to time t (AUC 0-t) of GSK2398852

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 11

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[66]	1 ^[67]
Units: Hourmicrograms per milliliter (hug/mL)
geometric mean (geometric coefficient of variation)
Session 1, n=6,1	5130.0 ( 46.72 )	2148.2 ( 88888 )
Session 2, n=6,0	14610.1 ( 34.73 )	99999 ( 99999 )
Session 3, n=6,0	13804.6 ( 50.34 )	99999 ( 99999 )
Session 4, n=5,0	12970.9 ( 51.52 )	99999 ( 99999 )
Session 5, n=4,0	15595.3 ( 51.13 )	99999 ( 99999 )
Session 6, n=4,0	17126.7 ( 43.98 )	99999 ( 99999 )

Notes
[66] - Safety Population
[67] - Safety Population

No statistical analyses for this end point

Secondary: Cmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

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End point title

Cmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

End point description

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.' 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'.

End point type

Secondary

End point 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)

Number of subjects analysed

Units: ug/mL

geometric mean (geometric coefficient of variation)

No statistical analyses for this end point

Secondary: Tmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

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End point title

Tmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

End point description

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'. 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'.

End point type

Secondary

End point 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)

Number of subjects analysed

Units: Hour

median (full range (min-max))

No statistical analyses for this end point

Secondary: AUC 0-t of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

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End point title

AUC 0-t of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

End point description

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'. 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'.

End point type

Secondary

End point 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)

Number of subjects analysed

Units: Hour*ug/mL

geometric mean (geometric coefficient of variation)

No statistical analyses for this end point

Secondary: Change from Baseline in Global Longitudinal Strain (GLS) by CMR

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End point title

Change from Baseline in Global Longitudinal Strain (GLS) by CMR

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[68]	1 ^[69]
Units: Percentage of myocardial shortening
arithmetic mean (standard deviation)
GLS Tagging, Session 2, Day 24, n=6,0	0.003 ( 0.2907 )	99999 ( 99999 )
GLS Tagging, Session 3, Day 24, n=6,0	0.229 ( 0.5836 )	99999 ( 99999 )
GLS Tagging, Session 4, Day 24, n=5,0	0.392 ( 0.4121 )	99999 ( 99999 )
GLS Tagging, Session 5, Day 24, n=4,0	0.349 ( 0.9354 )	99999 ( 99999 )
GLS Tagging, 8 Week follow-up, n=6,1	1.125 ( 1.6448 )	-3.404 ( 88888 )
GLS Tagging, 6 month follow-up, n=2,0	-1.014 ( 0.3654 )	99999 ( 99999 )
GLS Feature Tracking, Session 2, Day 24, n=6,0	1.729 ( 2.3613 )	99999 ( 99999 )
GLS Feature Tracking, Session 3, Day 24, n=6,0	0.803 ( 2.3712 )	99999 ( 99999 )
GLS Feature Tracking, Session 4, Day 24, n=5,0	1.326 ( 4.0639 )	99999 ( 99999 )
GLS Feature Tracking, Session 5, Day 24, n=4,0	1.657 ( 2.1277 )	99999 ( 99999 )
GLS Feature Tracking, 8 Week follow-up, n=6,1	0.639 ( 1.3678 )	3.951 ( 88888 )
GLS Feature Tracking, 6 month follow-up, n=2,0	1.234 ( 4.6888 )	99999 ( 99999 )

Notes
[68] - Safety Population
[69] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in GLS by ECHO

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End point title

Change from Baseline in GLS by ECHO

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[70]	1 ^[71]
Units: Percentage of myocardial shortening
arithmetic mean (standard deviation)
GLS Speckle Tracking, Session 1, Day 24, n=6,1	-3.55 ( 5.709 )	-0.90 ( 88888 )
GLS Speckle Tracking, Session 2, Day 24, n=6,0	-0.58 ( 6.013 )	99999 ( 99999 )
GLS Speckle Tracking, Session 3, Day 24, n=6,0	-1.17 ( 7.487 )	99999 ( 99999 )
GLS Speckle Tracking, Session 4, Day 24, n=5,0	1.26 ( 5.299 )	99999 ( 99999 )
GLS Speckle Tracking, Session 5, Day 24, n=4,0	1.13 ( 9.044 )	99999 ( 99999 )
GLS Speckle Tracking, Session 6, Day 24, n=4,0	-2.08 ( 4.555 )	99999 ( 99999 )
GLS Speckle Tracking, 8 Week follow-up, n=6,1	-1.82 ( 10.013 )	1.60 ( 88888 )
GLS Speckle Tracking, 6 month follow-up, n=4,0	0.40 ( 4.268 )	99999 ( 99999 )

Notes
[70] - Safety Population
[71] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in LV twist over time

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End point title

Change from Baseline in LV twist over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[72]	1 ^[73]
Units: Degree
arithmetic mean (standard deviation)
Session 2, Day 24, n=5,0	0.550 ( 1.6672 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	0.431 ( 2.4369 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-0.611 ( 1.8979 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-0.628 ( 1.2269 )	99999 ( 99999 )
8 Week follow-up, n=6,1	-0.264 ( 2.0835 )	0.914 ( 88888 )
6 month follow-up, n=2,0	-0.633 ( 0.3349 )	99999 ( 99999 )

Notes
[72] - Safety Population
[73] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Stroke Volume (SV) by CMR

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End point title

Change from Baseline in Stroke Volume (SV) by CMR

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[74]	1 ^[75]
Units: Milliliter
arithmetic mean (standard deviation)
Session 2, Day 24, n=6,0	-2.760 ( 7.8305 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	-1.228 ( 24.3834 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-9.766 ( 9.7838 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-11.477 ( 14.4238 )	99999 ( 99999 )
8 Week follow-up, n=6,1	2.400 ( 19.1252 )	-6.750 ( 88888 )
6 month follow-up, n=2,0	-6.160 ( 12.0491 )	99999 ( 99999 )

Notes
[74] - Safety Population
[75] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in SV by ECHO

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End point title

Change from Baseline in SV by ECHO

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[76]	1 ^[77]
Units: Milliliter
arithmetic mean (standard deviation)
Session 1, Day 24, n=6,1	2.580 ( 5.4518 )	-5.640 ( 88888 )
Session 2, Day 24, n=6,0	-1.885 ( 4.6569 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	-1.398 ( 8.0106 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-7.484 ( 6.5228 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-9.043 ( 9.5173 )	99999 ( 99999 )
Session 6, Day 24, n=4,0	-5.095 ( 7.1431 )	99999 ( 99999 )
8 Week follow-up, n=6,1	-4.343 ( 7.3457 )	-6.490 ( 88888 )
6 month follow-up, n=4,0	-4.275 ( 9.9743 )	99999 ( 99999 )

Notes
[76] - Safety Population
[77] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in left ventricular ejection fraction (EF) by CMR

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End point title

Change from Baseline in left ventricular ejection fraction (EF) by CMR

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[78]	1 ^[79]
Units: Percentage of ejected blood
arithmetic mean (standard deviation)
Session 2, Day 24, n=6,0	0.100 ( 3.9071 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	0.687 ( 11.7171 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-3.380 ( 5.4750 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-3.257 ( 7.9513 )	99999 ( 99999 )
8 Week follow-up, n=6,1	-1.258 ( 7.9932 )	-2.800 ( 88888 )
6 month follow-up, n=2,0	0.680 ( 8.7681 )	99999 ( 99999 )

Notes
[78] - Safety Population
[79] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in left ventricular EF by ECHO

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End point title

Change from Baseline in left ventricular EF by ECHO

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[80]	1 ^[81]
Units: Percentage of ejected blood
arithmetic mean (standard deviation)
Session 1, Day 24, n=6,1	2.10 ( 5.707 )	-7.40 ( 88888 )
Session 2, Day 24, n=6,0	-0.38 ( 3.111 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	-0.30 ( 3.318 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-2.74 ( 5.766 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-4.05 ( 7.832 )	99999 ( 99999 )
Session 6, Day 24, n=4,0	-3.53 ( 3.288 )	99999 ( 99999 )
8 Week follow-up, n=6,1	-1.72 ( 8.471 )	-3.20 ( 88888 )
6 month follow-up, n=4,0	1.20 ( 3.442 )	99999 ( 99999 )

Notes
[80] - Safety Population
[81] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in left ventricle End Diastolic Volume (EDV) by CMR

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End point title

Change from Baseline in left ventricle End Diastolic Volume (EDV) by CMR

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[82]	1 ^[83]
Units: Milliliter
arithmetic mean (standard deviation)
Session 2, Day 24, n=6,0	-3.473 ( 11.2584 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	1.653 ( 7.3322 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-5.262 ( 5.3765 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-9.323 ( 11.5275 )	99999 ( 99999 )
8 Week follow-up, n=6,1	9.887 ( 19.3925 )	-4.560 ( 88888 )
6 month follow-up, n=2,0	-21.030 ( 8.0469 )	99999 ( 99999 )

Notes
[82] - Safety Population
[83] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in left ventricle End Diastolic Volume (EDV) by ECHO

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End point title

Change from Baseline in left ventricle End Diastolic Volume (EDV) by ECHO

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[84]	1 ^[85]
Units: Milliliter
arithmetic mean (standard deviation)
Session 1, Day 24, n=6,1	0.050 ( 4.6276 )	-1.790 ( 88888 )
Session 2, Day 24, n=6,0	-2.940 ( 10.2320 )	99999 ( 99999 )
Session 3, Day 24, n=6,0	-2.922 ( 14.0019 )	99999 ( 99999 )
Session 4, Day 24, n=5,0	-12.338 ( 10.2249 )	99999 ( 99999 )
Session 5, Day 24, n=4,0	-11.860 ( 14.5676 )	99999 ( 99999 )
Session 6, Day 24, n=4,0	-5.073 ( 11.3679 )	99999 ( 99999 )
8 Week follow-up, n=6,1	-7.648 ( 4.4630 )	-7.100 ( 88888 )
6 month follow-up, n=4,0	-12.045 ( 20.2972 )	99999 ( 99999 )

Notes
[84] - Safety Population
[85] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in ratio of mitral peak velocity of early filling to early diastolic mitral annual velocity (E/e' ratio)

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End point title

Change from Baseline in ratio of mitral peak velocity of early filling to early diastolic mitral annual velocity (E/e' ratio)

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[86]	1 ^[87]
Units: Ratio
arithmetic mean (standard deviation)
E/e Lateral Ratio, Session 1, Day 24, n=6,1	-1.55 ( 2.813 )	-2.80 ( 88888 )
E/e Lateral Ratio, Session 2, Day 24, n=6,0	-0.77 ( 3.555 )	99999 ( 99999 )
E/e Lateral Ratio, Session 3, Day 24, n=6,0	3.20 ( 2.197 )	99999 ( 99999 )
E/e Lateral Ratio, Session 4, Day 24, n=5,0	-0.64 ( 4.750 )	99999 ( 99999 )
E/e Lateral Ratio, Session 5, Day 24, n=4,0	1.22 ( 5.134 )	99999 ( 99999 )
E/e Lateral Ratio, Session 6, Day 24, n=4,0	3.25 ( 2.300 )	99999 ( 99999 )
E/e Lateral Ratio, 8 Week follow-up, n=6,1	0.05 ( 2.681 )	2.90 ( 88888 )
E/e Lateral Ratio, 6 month follow-up, n=4,0	-0.58 ( 4.442 )	99999 ( 99999 )
E/e Septal Ratio, Session 1, Day 24, n=6,1	0.50 ( 2.995 )	-2.00 ( 88888 )
E/e Septal Ratio, Session 2, Day 24, n=6,0	0.52 ( 4.640 )	99999 ( 99999 )
E/e Septal Ratio, Session 3, Day 24, n=6,0	5.33 ( 5.136 )	99999 ( 99999 )
E/e Septal Ratio, Session 4, Day 24, n=5,0	2.96 ( 3.462 )	99999 ( 99999 )
E/e Septal Ratio, Session 5, Day 24, n=4,0	4.48 ( 3.010 )	99999 ( 99999 )
E/e Septal Ratio, Session 6, Day 24, n=4,0	6.23 ( 5.917 )	99999 ( 99999 )
E/e Septal Ratio, 8 Week follow-up, n=6,0	2.83 ( 4.236 )	99999 ( 99999 )
E/e Septal Ratio, 6 month follow-up, n=4,0	4.95 ( 1.708 )	99999 ( 99999 )

Notes
[86] - Safety Population
[87] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in plasma cytokines over time

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End point title

Change from Baseline in plasma cytokines over time

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not available. 88888 indicates data is not available, as standard deviation could not be calculated as only one participant was analyzed.

End point type

Secondary

End point 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 5

End point values	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants	Group 2: Post-chemotherapy AL Amyloidosis participants
Number of subjects analysed	6 ^[88]	1 ^[89]
Units: Nanograms per liter (ng/L)
arithmetic mean (standard deviation)
IL-1 beta, Session 1, Day 1, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 1, 1 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 1, 3 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 1, 6 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 2, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 3, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-1 beta, Session 1, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 1, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 1, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 1, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 1, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day -2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 2, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 3, 1 hour, n=6,0	0.293 ( 0.7185 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 3, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 1, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 1, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 1, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 1, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 3, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 3, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 3, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 3, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 4, n=5,0	0.504 ( 1.1270 )	99999 ( 99999 )
IL-1 beta, Session 4, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 5, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-1 beta, Session 6, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-6, Session 1, Day 1, predose, n=6,1	0.275 ( 0.4711 )	0.000 ( 88888 )
IL-6, Session 1, Day 1, 1 hour, n=6,1	-0.080 ( 0.7723 )	0.000 ( 88888 )
IL-6, Session 1, Day 1, 3 hour, n=6,1	-0.727 ( 1.2035 )	0.000 ( 88888 )
IL-6, Session 1, Day 1, 6 hour, n=6,1	-1.077 ( 1.2511 )	2.880 ( 88888 )
IL-6, Session 1, Day 2, n=6,1	6.278 ( 6.3567 )	29.030 ( 88888 )
IL-6, Session 1, Day 3, predose, n=6,1	7.688 ( 8.8639 )	16.980 ( 88888 )
IL-6, Session 1, Day 3, 1 hour, n=6,0	6.857 ( 10.5934 )	99999 ( 99999 )
IL-6, Session 1, Day 3, 3 hour, n=6,0	0.827 ( 3.5790 )	99999 ( 99999 )
IL-6, Session 1, Day 3, 6 hour, n=6,0	0.932 ( 5.5637 )	99999 ( 99999 )
IL-6, Session 1, Day 4, n=6,0	5.453 ( 3.6039 )	99999 ( 99999 )
IL-6, Session 1, Day 5, n=6,0	3.245 ( 3.3934 )	99999 ( 99999 )
IL-6, Session 2, Day -2, n=6,0	0.393 ( 0.5250 )	99999 ( 99999 )
IL-6, Session 2, Day 1, predose, n=6,0	0.632 ( 1.2026 )	99999 ( 99999 )
IL-6, Session 2, Day 1, 1 hour, n=6,0	0.025 ( 0.7117 )	99999 ( 99999 )
IL-6, Session 2, Day 1, 3 hour, n=6,0	-0.860 ( 1.0909 )	99999 ( 99999 )
IL-6, Session 2, Day 1, 6 hour, n=6,0	-0.282 ( 1.7148 )	99999 ( 99999 )
IL-6, Session 2, Day 2, n=6,0	21.590 ( 27.1214 )	99999 ( 99999 )
IL-6, Session 2, Day 3, predose, n=6,0	11.365 ( 11.4140 )	99999 ( 99999 )
IL-6, Session 2, Day 3, 1 hour, n=6,0	7.517 ( 8.6084 )	99999 ( 99999 )
IL-6, Session 2, Day 3, 3 hour, n=6,0	3.460 ( 5.0176 )	99999 ( 99999 )
IL-6, Session 2, Day 3, 6 hour, n=6,0	0.723 ( 4.5392 )	99999 ( 99999 )
IL-6, Session 2, Day 4, n=6,0	4.580 ( 5.9326 )	99999 ( 99999 )
IL-6, Session 2, Day 5, n=6,0	6.395 ( 5.2800 )	99999 ( 99999 )
IL-6, Session 3, Day -2, n=5,0	0.148 ( 0.8211 )	99999 ( 99999 )
IL-6, Session 3, Day 1, predose, n=6,0	0.782 ( 1.5023 )	99999 ( 99999 )
IL-6, Session 3, Day 1, 1 hour, n=6,0	0.268 ( 1.4865 )	99999 ( 99999 )
IL-6, Session 3, Day 1, 3 hour, n=6,0	0.062 ( 2.5899 )	99999 ( 99999 )
IL-6, Session 3, Day 1, 6 hour, n=6,0	-0.918 ( 1.2591 )	99999 ( 99999 )
IL-6, Session 3, Day 2, n=5,0	17.608 ( 29.2558 )	99999 ( 99999 )
IL-6, Session 3, Day 3, predose, n=6,0	11.872 ( 8.7413 )	99999 ( 99999 )
IL-6, Session 3, Day 3, 1 hour, n=6,0	5.835 ( 3.8271 )	99999 ( 99999 )
IL-6, Session 3, Day 3, 3 hour, n=6,0	1.742 ( 1.9174 )	99999 ( 99999 )
IL-6, Session 3, Day 3, 6 hour, n=6,0	0.063 ( 2.2072 )	99999 ( 99999 )
IL-6, Session 3, Day 4, n=6,0	4.667 ( 6.9875 )	99999 ( 99999 )
IL-6, Session 3, Day 5, n=6,0	5.570 ( 2.6004 )	99999 ( 99999 )
IL-6, Session 4, Day -2, n=5,0	0.892 ( 0.8423 )	99999 ( 99999 )
IL-6, Session 4, Day 1, predose, n=5,0	1.486 ( 0.8702 )	99999 ( 99999 )
IL-6, Session 4, Day 1, 1 hour, n=5,0	0.926 ( 0.7103 )	99999 ( 99999 )
IL-6, Session 4, Day 1, 3 hour, n=5,0	-0.026 ( 0.1599 )	99999 ( 99999 )
IL-6, Session 4, Day 1, 6 hour, n=5,0	-1.028 ( 1.3685 )	99999 ( 99999 )
IL-6, Session 4, Day 2, n=5,0	5.720 ( 11.3851 )	99999 ( 99999 )
IL-6, Session 4, Day 3, predose, n=5,0	10.924 ( 6.5370 )	99999 ( 99999 )
IL-6, Session 4, Day 3, 1 hour, n=5,0	4.486 ( 2.0420 )	99999 ( 99999 )
IL-6, Session 4, Day 3, 3 hour, n=5,0	1.446 ( 1.5368 )	99999 ( 99999 )
IL-6, Session 4, Day 3, 6 hour, n=5,0	-0.116 ( 1.7948 )	99999 ( 99999 )
IL-6, Session 4, Day 4, n=5,0	5.756 ( 6.8645 )	99999 ( 99999 )
IL-6, Session 4, Day 5, n=4,0	4.388 ( 3.7765 )	99999 ( 99999 )
IL-6, Session 5, Day -2, n=4,0	0.027 ( 0.8164 )	99999 ( 99999 )
IL-6, Session 5, Day 1, predose, n=4,0	0.865 ( 0.9927 )	99999 ( 99999 )
IL-6, Session 5, Day 1, 1 hour, n=4,0	-0.007 ( 1.3219 )	99999 ( 99999 )
IL-6, Session 5, Day 1, 3 hour, n=4,0	-0.423 ( 1.5816 )	99999 ( 99999 )
IL-6, Session 5, Day 1, 6 hour, n=4,0	-1.213 ( 1.5189 )	99999 ( 99999 )
IL-6, Session 5, Day 2, n=4,0	0.905 ( 4.0920 )	99999 ( 99999 )
IL-6, Session 5, Day 3, predose, n=4,0	7.323 ( 4.8265 )	99999 ( 99999 )
IL-6, Session 5, Day 3, 1 hour, n=4,0	4.240 ( 3.6214 )	99999 ( 99999 )
IL-6, Session 5, Day 3, 3 hour, n=4,0	-0.125 ( 0.7543 )	99999 ( 99999 )
IL-6, Session 5, Day 3, 6 hour, n=4,0	-1.390 ( 1.3301 )	99999 ( 99999 )
IL-6, Session 5, Day 4, n=4,0	3.598 ( 5.7476 )	99999 ( 99999 )
IL-6, Session 5, Day 5, n=4,0	6.533 ( 2.6812 )	99999 ( 99999 )
IL-6, Session 6, Day -2, n=4,0	1.383 ( 1.8535 )	99999 ( 99999 )
IL-6, Session 6, Day 1, predose, n=4,0	0.565 ( 1.4007 )	99999 ( 99999 )
IL-6, Session 6, Day 1, 1 hour, n=4,0	0.077 ( 1.1200 )	99999 ( 99999 )
IL-6, Session 6, Day 1, 3 hour, n=4,0	-0.413 ( 1.4416 )	99999 ( 99999 )
IL-6, Session 6, Day 1, 6 hour, n=4,0	-1.165 ( 0.9786 )	99999 ( 99999 )
IL-6, Session 6, Day 2, n=4,0	0.932 ( 4.0340 )	99999 ( 99999 )
IL-6, Session 6, Day 3, predose, n=4,0	15.008 ( 13.0010 )	99999 ( 99999 )
IL-6, Session 6, Day 3, 1 hour, n=4,0	10.083 ( 9.2076 )	99999 ( 99999 )
IL-6, Session 6, Day 3, 3 hour, n=4,0	1.435 ( 1.7505 )	99999 ( 99999 )
IL-6, Session 6, Day 3, 6 hour, n=4,0	-1.005 ( 1.3522 )	99999 ( 99999 )
IL-6, Session 6, Day 4, n=4,0	1.740 ( 3.2649 )	99999 ( 99999 )
IL-6, Session 6, Day 5, n=4,0	7.190 ( 3.8811 )	99999 ( 99999 )
IL-10, Session 1, Day 1, predose, n=6,1	-0.067 ( 0.1633 )	0.000 ( 88888 )
IL-10, Session 1, Day 1, 1 hour, n=6,1	0.105 ( 0.1663 )	8.580 ( 88888 )
IL-10, Session 1, Day 1, 3 hour, n=6,1	0.763 ( 0.4804 )	5.260 ( 88888 )
IL-10, Session 1, Day 1, 6 hour, n=6,1	1.710 ( 1.4719 )	6.020 ( 88888 )
IL-10, Session 1, Day 2, n=6,1	-0.005 ( 0.2436 )	1.150 ( 88888 )
IL-10, Session 1, Day 3, predose, n=6,1	0.040 ( 0.3347 )	1.280 ( 88888 )
IL-10, Session 1, Day 3, 1 hour, n=6,0	0.670 ( 1.0153 )	99999 ( 99999 )
IL-10, Session 1, Day 3, 3 hour, n=6,0	0.065 ( 0.3896 )	99999 ( 99999 )
IL-10, Session 1, Day 3, 6 hour, n=6,0	0.002 ( 0.0041 )	99999 ( 99999 )
IL-10, Session 1, Day 4, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 1, Day 5, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 2, Day -2, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 2, Day 1, predose, n=6,0	0.002 ( 0.0041 )	99999 ( 99999 )
IL-10, Session 2, Day 1, 1 hour, n=6,0	0.612 ( 0.8293 )	99999 ( 99999 )
IL-10, Session 2, Day 1, 3 hour, n=6,0	1.132 ( 1.1748 )	99999 ( 99999 )
IL-10, Session 2, Day 1, 6 hour, n=6,0	0.785 ( 0.5189 )	99999 ( 99999 )
IL-10, Session 2, Day 2, n=6,0	0.012 ( 0.2757 )	99999 ( 99999 )
IL-10, Session 2, Day 3, predose, n=6,0	0.233 ( 0.5618 )	99999 ( 99999 )
IL-10, Session 2, Day 3, 1 hour, n=6,0	0.775 ( 1.1274 )	99999 ( 99999 )
IL-10, Session 2, Day 3, 3 hour, n=6,0	0.782 ( 0.8451 )	99999 ( 99999 )
IL-10, Session 2, Day 3, 6 hour, n=6,0	0.015 ( 0.0367 )	99999 ( 99999 )
IL-10, Session 2, Day 4, n=6,0	-0.005 ( 0.0122 )	99999 ( 99999 )
IL-10, Session 2, Day 5, n=6,0	0.110 ( 0.2122 )	99999 ( 99999 )
IL-10, Session 3, Day -2, n=5,0	0.032 ( 0.3422 )	99999 ( 99999 )
IL-10, Session 3, Day 1, predose, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 3, Day 1, 1 hour, n=6,0	0.228 ( 0.2328 )	99999 ( 99999 )
IL-10, Session 3, Day 1, 3 hour, n=6,0	1.185 ( 1.1559 )	99999 ( 99999 )
IL-10, Session 3, Day 1, 6 hour, n=6,0	0.495 ( 0.6641 )	99999 ( 99999 )
IL-10, Session 3, Day 2, n=5,0	-0.080 ( 0.1789 )	99999 ( 99999 )
IL-10, Session 3, Day 3, predose, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 3, Day 3, 1 hour, n=6,0	0.450 ( 0.6048 )	99999 ( 99999 )
IL-10, Session 3, Day 3, 3 hour, n=6,0	0.322 ( 0.5322 )	99999 ( 99999 )
IL-10, Session 3, Day 3, 6 hour, n=6,0	0.092 ( 0.1542 )	99999 ( 99999 )
IL-10, Session 3, Day 4, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 3, Day 5, n=6,0	-0.067 ( 0.1633 )	99999 ( 99999 )
IL-10, Session 4, Day -2, n=5,0	-0.080 ( 0.1789 )	99999 ( 99999 )
IL-10, Session 4, Day 1, predose, n=5,0	-0.080 ( 0.1789 )	99999 ( 99999 )
IL-10, Session 4, Day 1, 1 hour, n=5,0	0.758 ( 1.4466 )	99999 ( 99999 )
IL-10, Session 4, Day 1, 3 hour, n=5,0	3.868 ( 6.3123 )	99999 ( 99999 )
IL-10, Session 4, Day 1, 6 hour, n=5,0	0.868 ( 0.9281 )	99999 ( 99999 )
IL-10, Session 4, Day 2, n=5,0	-0.080 ( 0.1789 )	99999 ( 99999 )
IL-10, Session 4, Day 3, predose, n=5,0	0.022 ( 0.0492 )	99999 ( 99999 )
IL-10, Session 4, Day 3, 1 hour, n=5,0	0.808 ( 1.0592 )	99999 ( 99999 )
IL-10, Session 4, Day 3, 3 hour, n=5,0	0.598 ( 0.6549 )	99999 ( 99999 )
IL-10, Session 4, Day 3, 6 hour, n=5,0	0.184 ( 0.4284 )	99999 ( 99999 )
IL-10, Session 4, Day 4, n=5,0	-0.080 ( 0.1789 )	99999 ( 99999 )
IL-10, Session 4, Day 5, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 5, Day -2, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 5, Day 1, predose, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 5, Day 1, 1 hour, n=4,0	2.485 ( 4.8507 )	99999 ( 99999 )
IL-10, Session 5, Day 1, 3 hour, n=4,0	3.828 ( 6.5828 )	99999 ( 99999 )
IL-10, Session 5, Day 1, 6 hour, n=4,0	1.120 ( 1.5607 )	99999 ( 99999 )
IL-10, Session 5, Day 2, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 5, Day 3, predose, n=4,0	0.393 ( 0.4774 )	99999 ( 99999 )
IL-10, Session 5, Day 3, 1 hour, n=4,0	0.950 ( 0.9330 )	99999 ( 99999 )
IL-10, Session 5, Day 3, 3 hour, n=4,0	1.060 ( 0.9783 )	99999 ( 99999 )
IL-10, Session 5, Day 3, 6 hour, n=4,0	0.663 ( 0.6663 )	99999 ( 99999 )
IL-10, Session 5, Day 4, n=4,0	0.210 ( 0.4267 )	99999 ( 99999 )
IL-10, Session 5, Day 5, n=4,0	0.025 ( 0.0500 )	99999 ( 99999 )
IL-10, Session 6, Day -2, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 6, Day 1, predose, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 6, Day 1, 1 hour, n=4,0	0.333 ( 0.9506 )	99999 ( 99999 )
IL-10, Session 6, Day 1, 3 hour, n=4,0	1.738 ( 2.5365 )	99999 ( 99999 )
IL-10, Session 6, Day 1, 6 hour, n=4,0	1.418 ( 1.7245 )	99999 ( 99999 )
IL-10, Session 6, Day 2, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 6, Day 3, predose, n=4,0	0.015 ( 0.0300 )	99999 ( 99999 )
IL-10, Session 6, Day 3, 1 hour, n=4,0	0.753 ( 1.4004 )	99999 ( 99999 )
IL-10, Session 6, Day 3, 3 hour, n=4,0	0.675 ( 1.1466 )	99999 ( 99999 )
IL-10, Session 6, Day 3, 6 hour, n=4,0	0.220 ( 0.2723 )	99999 ( 99999 )
IL-10, Session 6, Day 4, n=4,0	-0.100 ( 0.2000 )	99999 ( 99999 )
IL-10, Session 6, Day 5, n=4,0	0.023 ( 0.0450 )	99999 ( 99999 )
TNF, Session 1, Day 1, predose, n=6,1	0.055 ( 0.4378 )	0.320 ( 88888 )
TNF, Session 1, Day 1, 1 hour, n=6,1	0.007 ( 0.7159 )	0.100 ( 88888 )
TNF, Session 1, Day 1, 3 hour, n=6,1	-0.180 ( 0.7430 )	0.880 ( 88888 )
TNF, Session 1, Day 1, 6 hour, n=6,1	-0.132 ( 0.8145 )	2.300 ( 88888 )
TNF, Session 1, Day 2, n=6,1	1.920 ( 1.5379 )	5.130 ( 88888 )
TNF, Session 1, Day 3, predose, n=6,1	1.453 ( 1.3405 )	3.010 ( 88888 )
TNF, Session 1, Day 3, 1 hour, n=6,0	1.240 ( 0.9968 )	99999 ( 99999 )
TNF, Session 1, Day 3, 3 hour, n=6,0	0.797 ( 1.0229 )	99999 ( 99999 )
TNF, Session 1, Day 3, 6 hour, n=6,0	0.460 ( 0.9373 )	99999 ( 99999 )
TNF, Session 1, Day 4, n=6,0	1.088 ( 1.2874 )	99999 ( 99999 )
TNF, Session 1, Day 5, n=6,0	1.577 ( 1.5915 )	99999 ( 99999 )
TNF, Session 2, Day -2, n=6,0	0.167 ( 0.9735 )	99999 ( 99999 )
TNF, Session 2, Day 1, predose, n=6,0	0.233 ( 0.8351 )	99999 ( 99999 )
TNF, Session 2, Day 1, 1 hour, n=6,0	0.133 ( 1.0259 )	99999 ( 99999 )
TNF, Session 2, Day 1, 3 hour, n=6,0	0.015 ( 1.0940 )	99999 ( 99999 )
TNF, Session 2, Day 1, 6 hour, n=6,0	-0.100 ( 1.2625 )	99999 ( 99999 )
TNF, Session 2, Day 2, n=6,0	1.523 ( 1.6646 )	99999 ( 99999 )
TNF, Session 2, Day 3, predose, n=6,0	2.143 ( 1.5642 )	99999 ( 99999 )
TNF, Session 2, Day 3, 1 hour, n=6,0	1.682 ( 1.3855 )	99999 ( 99999 )
TNF, Session 2, Day 3, 3 hour, n=6,0	1.133 ( 0.9970 )	99999 ( 99999 )
TNF, Session 2, Day 3, 6 hour, n=6,0	0.503 ( 1.0718 )	99999 ( 99999 )
TNF, Session 2, Day 4, n=6,0	1.397 ( 2.1712 )	99999 ( 99999 )
TNF, Session 2, Day 5, n=6,0	1.968 ( 1.4560 )	99999 ( 99999 )
TNF, Session 3, Day -2, n=5,0	0.098 ( 1.2163 )	99999 ( 99999 )
TNF, Session 3, Day 1, predose, n=6,0	0.497 ( 0.9650 )	99999 ( 99999 )
TNF, Session 3, Day 1, 1 hour, n=6,0	-0.297 ( 0.9572 )	99999 ( 99999 )
TNF, Session 3, Day 1, 3 hour, n=6,0	-0.198 ( 0.9246 )	99999 ( 99999 )
TNF, Session 3, Day 1, 6 hour, n=6,0	-0.167 ( 1.2317 )	99999 ( 99999 )
TNF, Session 3, Day 2, n=5,0	0.446 ( 1.1212 )	99999 ( 99999 )
TNF, Session 3, Day 3, predose, n=6,0	1.267 ( 1.1583 )	99999 ( 99999 )
TNF, Session 3, Day 3, 1 hour, n=6,0	0.513 ( 1.1234 )	99999 ( 99999 )
TNF, Session 3, Day 3, 3 hour, n=6,0	0.128 ( 1.0706 )	99999 ( 99999 )
TNF, Session 3, Day 3, 6 hour, n=6,0	0.233 ( 1.2605 )	99999 ( 99999 )
TNF, Session 3, Day 4, n=6,0	0.585 ( 1.6017 )	99999 ( 99999 )
TNF, Session 3, Day 5, n=6,0	0.997 ( 1.3819 )	99999 ( 99999 )
TNF, Session 4, Day -2, n=5,0	-0.208 ( 0.5949 )	99999 ( 99999 )
TNF, Session 4, Day 1, predose, n=5,0	-0.214 ( 0.8527 )	99999 ( 99999 )
TNF, Session 4, Day 1, 1 hour, n=5,0	0.160 ( 1.5494 )	99999 ( 99999 )
TNF, Session 4, Day 1, 3 hour, n=5,0	0.218 ( 1.5011 )	99999 ( 99999 )
TNF, Session 4, Day 1, 6 hour, n=5,0	-0.412 ( 1.1373 )	99999 ( 99999 )
TNF, Session 4, Day 2, n=5,0	-0.122 ( 0.6977 )	99999 ( 99999 )
TNF, Session 4, Day 3, predose, n=5,0	0.606 ( 0.5265 )	99999 ( 99999 )
TNF, Session 4, Day 3, 1 hour, n=5,0	0.100 ( 0.5074 )	99999 ( 99999 )
TNF, Session 4, Day 3, 3 hour, n=5,0	0.098 ( 0.7172 )	99999 ( 99999 )
TNF, Session 4, Day 3, 6 hour, n=5,0	-0.702 ( 0.5368 )	99999 ( 99999 )
TNF, Session 4, Day 4, n=5,0	-0.270 ( 0.7576 )	99999 ( 99999 )
TNF, Session 4, Day 5, n=4,0	0.095 ( 0.4456 )	99999 ( 99999 )
TNF, Session 5, Day -2, n=4,0	-0.350 ( 0.5814 )	99999 ( 99999 )
TNF, Session 5, Day 1, predose, n=4,0	-0.320 ( 0.6703 )	99999 ( 99999 )
TNF, Session 5, Day 1, 1 hour, n=4,0	-0.130 ( 1.2227 )	99999 ( 99999 )
TNF, Session 5, Day 1, 3 hour, n=4,0	-0.055 ( 1.0728 )	99999 ( 99999 )
TNF, Session 5, Day 1, 6 hour, n=4,0	-0.513 ( 1.1003 )	99999 ( 99999 )
TNF, Session 5, Day 2, n=4,0	-0.498 ( 0.9752 )	99999 ( 99999 )
TNF, Session 5, Day 3, predose, n=4,0	0.147 ( 0.8951 )	99999 ( 99999 )
TNF, Session 5, Day 3, 1 hour, n=4,0	-0.188 ( 0.7406 )	99999 ( 99999 )
TNF, Session 5, Day 3, 3 hour, n=4,0	-0.378 ( 0.9306 )	99999 ( 99999 )
TNF, Session 5, Day 3, 6 hour, n=4,0	-0.630 ( 0.7857 )	99999 ( 99999 )
TNF, Session 5, Day 4, n=4,0	-0.100 ( 1.0725 )	99999 ( 99999 )
TNF, Session 5, Day 5, n=4,0	0.168 ( 0.3909 )	99999 ( 99999 )
TNF, Session 6, Day -2, n=4,0	-0.428 ( 1.3664 )	99999 ( 99999 )
TNF, Session 6, Day 1, predose, n=4,0	-0.238 ( 1.3158 )	99999 ( 99999 )
TNF, Session 6, Day 1, 1 hour, n=4,0	-0.303 ( 1.3853 )	99999 ( 99999 )
TNF, Session 6, Day 1, 3 hour, n=4,0	-0.145 ( 1.8684 )	99999 ( 99999 )
TNF, Session 6, Day 1, 6 hour, n=4,0	-0.500 ( 1.4020 )	99999 ( 99999 )
TNF, Session 6, Day 2, n=4,0	-0.000 ( 1.3253 )	99999 ( 99999 )
TNF, Session 6, Day 3, predose, n=4,0	0.278 ( 1.9987 )	99999 ( 99999 )
TNF, Session 6, Day 3, 1 hour, n=4,0	-0.195 ( 1.6007 )	99999 ( 99999 )
TNF, Session 6, Day 3, 3 hour, n=4,0	-0.385 ( 1.4669 )	99999 ( 99999 )
TNF, Session 6, Day 3, 6 hour, n=4,0	-0.585 ( 1.3026 )	99999 ( 99999 )
TNF, Session 6, Day 4, n=4,0	-0.368 ( 1.1280 )	99999 ( 99999 )
TNF, Session 6, Day 5, n=4,0	0.322 ( 1.2795 )	99999 ( 99999 )
INF gamma, Session 1, Day 1, predose, n=6,1	0.075 ( 1.6224 )	1.860 ( 88888 )
INF gamma, Session 1, Day 1, 1 hour, n=6,1	-1.373 ( 2.1255 )	0.000 ( 88888 )
INF gamma, Session 1, Day 1, 3 hour, n=6,1	-3.298 ( 3.1409 )	0.000 ( 88888 )
INF gamma, Session 1, Day 1, 6 hour, n=6,1	-3.298 ( 3.1409 )	0.000 ( 88888 )
INF gamma, Session 1, Day 2, n=6,1	1.713 ( 7.5955 )	1.930 ( 88888 )
INF gamma, Session 1, Day 3, predose, n=6,1	17.122 ( 27.3980 )	0.000 ( 88888 )
INF gamma, Session 1, Day 3, 1 hour, n=6,0	12.118 ( 22.0807 )	99999 ( 99999 )
INF gamma, Session 1, Day 3, 3 hour, n=6,0	7.150 ( 18.4949 )	99999 ( 99999 )
INF gamma, Session 1, Day 3, 6 hour, n=6,0	0.538 ( 8.5114 )	99999 ( 99999 )
INF gamma, Session 1, Day 4, n=6,0	3.242 ( 12.2847 )	99999 ( 99999 )
INF gamma, Session 1, Day 5, n=6,0	19.502 ( 38.3215 )	99999 ( 99999 )
INF gamma, Session 2, Day -2, n=6,0	-1.045 ( 3.4175 )	99999 ( 99999 )
INF gamma, Session 2, Day 1, predose, n=6,0	0.452 ( 3.5018 )	99999 ( 99999 )
INF gamma, Session 2, Day 1, 1 hour, n=6,0	0.145 ( 3.2180 )	99999 ( 99999 )
INF gamma, Session 2, Day 1, 3 hour, n=6,0	-1.833 ( 1.3991 )	99999 ( 99999 )
INF gamma, Session 2, Day 1, 6 hour, n=6,0	-3.072 ( 2.6378 )	99999 ( 99999 )
INF gamma, Session 2, Day 2, n=6,0	-2.660 ( 3.5043 )	99999 ( 99999 )
INF gamma, Session 2, Day 3, predose, n=6,0	-1.045 ( 2.2260 )	99999 ( 99999 )
INF gamma, Session 2, Day 3, 1 hour, n=6,0	-1.580 ( 2.5672 )	99999 ( 99999 )
INF gamma, Session 2, Day 3, 3 hour, n=6,0	-2.473 ( 2.5631 )	99999 ( 99999 )
INF gamma, Session 2, Day 3, 6 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 2, Day 4, n=6,0	-2.572 ( 3.4040 )	99999 ( 99999 )
INF gamma, Session 2, Day 5, n=6,0	-1.993 ( 2.8977 )	99999 ( 99999 )
INF gamma, Session 3, Day -2, n=5,0	-2.190 ( 3.9839 )	99999 ( 99999 )
INF gamma, Session 3, Day 1, predose, n=6,0	-1.035 ( 4.4739 )	99999 ( 99999 )
INF gamma, Session 3, Day 1, 1 hour, n=6,0	-2.180 ( 3.8365 )	99999 ( 99999 )
INF gamma, Session 3, Day 1, 3 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 3, Day 1, 6 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 3, Day 2, n=5,0	-2.936 ( 3.7855 )	99999 ( 99999 )
INF gamma, Session 3, Day 3, predose, n=6,0	-2.948 ( 2.3737 )	99999 ( 99999 )
INF gamma, Session 3, Day 3, 1 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 3, Day 3, 3 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 3, Day 3, 6 hour, n=6,0	-3.298 ( 3.1409 )	99999 ( 99999 )
INF gamma, Session 3, Day 4, n=6,0	-3.048 ( 3.1886 )	99999 ( 99999 )
INF gamma, Session 3, Day 5, n=6,0	-2.752 ( 3.2989 )	99999 ( 99999 )
INF gamma, Session 4, Day -2, n=5,0	0.298 ( 5.3631 )	99999 ( 99999 )
INF gamma, Session 4, Day 1, predose, n=5,0	-0.760 ( 4.2290 )	99999 ( 99999 )
INF gamma, Session 4, Day 1, 1 hour, n=5,0	-1.240 ( 4.3736 )	99999 ( 99999 )
INF gamma, Session 4, Day 1, 3 hour, n=5,0	-2.778 ( 3.9570 )	99999 ( 99999 )
INF gamma, Session 4, Day 1, 6 hour, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 2, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 3, predose, n=5,0	-2.836 ( 2.6051 )	99999 ( 99999 )
INF gamma, Session 4, Day 3, 1 hour, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 3, 3 hour, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 3, 6 hour, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 4, n=5,0	-3.274 ( 3.5110 )	99999 ( 99999 )
INF gamma, Session 4, Day 5, n=4,0	-2.910 ( 3.1667 )	99999 ( 99999 )
INF gamma, Session 5, Day -2, n=4,0	-0.930 ( 3.5480 )	99999 ( 99999 )
INF gamma, Session 5, Day 1, predose, n=4,0	-1.328 ( 2.1878 )	99999 ( 99999 )
INF gamma, Session 5, Day 1, 1 hour, n=4,0	-1.423 ( 1.9828 )	99999 ( 99999 )
INF gamma, Session 5, Day 1, 3 hour, n=4,0	-2.725 ( 2.8230 )	99999 ( 99999 )
INF gamma, Session 5, Day 1, 6 hour, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 5, Day 2, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 5, Day 3, predose, n=4,0	0.753 ( 4.9155 )	99999 ( 99999 )
INF gamma, Session 5, Day 3, 1 hour, n=4,0	0.203 ( 4.5195 )	99999 ( 99999 )
INF gamma, Session 5, Day 3, 3 hour, n=4,0	-1.388 ( 4.8505 )	99999 ( 99999 )
INF gamma, Session 5, Day 3, 6 hour, n=4,0	-2.838 ( 4.4804 )	99999 ( 99999 )
INF gamma, Session 5, Day 4, n=4,0	-1.653 ( 6.0355 )	99999 ( 99999 )
INF gamma, Session 5, Day 5, n=4,0	-0.615 ( 2.9091 )	99999 ( 99999 )
INF gamma, Session 6, Day -2, n=4,0	-2.625 ( 4.4662 )	99999 ( 99999 )
INF gamma, Session 6, Day 1, predose, n=4,0	-2.668 ( 4.4299 )	99999 ( 99999 )
INF gamma, Session 6, Day 1, 1 hour, n=4,0	-2.823 ( 4.3091 )	99999 ( 99999 )
INF gamma, Session 6, Day 1, 3 hour, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 1, 6 hour, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 2, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 3, predose, n=4,0	-1.988 ( 5.0857 )	99999 ( 99999 )
INF gamma, Session 6, Day 3, 1 hour, n=4,0	-3.018 ( 4.1848 )	99999 ( 99999 )
INF gamma, Session 6, Day 3, 3 hour, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 3, 6 hour, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 4, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
INF gamma, Session 6, Day 5, n=4,0	-3.373 ( 4.0462 )	99999 ( 99999 )
IL-12, Session 1, Day 1, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 1, 1 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 1, 3 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 1, 6 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 2, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 3, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-12, Session 1, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 1, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 1, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 1, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 1, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day -2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 2, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 3, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 1, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 1, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 1, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 1, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 3, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 3, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 3, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 3, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 4, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 4, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 5, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-12, Session 6, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 1, Day 1, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 1, 1 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 1, 3 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 1, 6 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 2, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 3, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-13, Session 1, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 1, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 1, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 1, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 1, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day -2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 2, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 3, predose, n=6,0	0.333 ( 0.8165 )	99999 ( 99999 )
IL-13, Session 3, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 3, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 1, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 1, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 1, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 1, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 3, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 3, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 3, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 3, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 4, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 4, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 3, 1 hour, n=4,0	0.283 ( 0.5650 )	99999 ( 99999 )
IL-13, Session 5, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 5, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-13, Session 6, Day 4, n=4,0	0.488 ( 0.9750 )	99999 ( 99999 )
IL-13, Session 6, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 1, Day 1, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 1, 1 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 1, 3 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 1, 6 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 2, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 3, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-2, Session 1, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 1, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 1, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 1, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 1, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day -2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 2, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 3, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 1, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 1, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 1, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 1, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 3, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 3, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 3, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 3, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 4, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 4, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 5, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-2, Session 6, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 1, Day 1, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 1, 1 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 1, 3 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 1, 6 hour, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 2, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 3, predose, n=6,1	0.000 ( 0.0000 )	0.000 ( 88888 )
IL-4, Session 1, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 1, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 1, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 1, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 1, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day -2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 2, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 2, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 1, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 1, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 1, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 1, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 3, predose, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 3, 1 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 3, 3 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 3, 6 hour, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 4, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 3, Day 5, n=6,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day -2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 1, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 1, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 1, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 1, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 2, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 3, predose, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 3, 1 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 3, 3 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 3, 6 hour, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 4, n=5,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 4, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 5, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day -2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 1, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 1, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 1, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 1, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 2, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 3, predose, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 3, 1 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 3, 3 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 3, 6 hour, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 4, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-4, Session 6, Day 5, n=4,0	0.000 ( 0.0000 )	99999 ( 99999 )
IL-8, Session 1, Day 1, predose, n=6,1	4.377 ( 5.8881 )	1.140 ( 88888 )
IL-8, Session 1, Day 1, 1 hour, n=6,1	4.887 ( 12.0436 )	0.450 ( 88888 )
IL-8, Session 1, Day 1, 3 hour, n=6,1	1.097 ( 6.7834 )	0.480 ( 88888 )
IL-8, Session 1, Day 1, 6 hour, n=6,1	4.400 ( 9.5000 )	8.350 ( 88888 )
IL-8, Session 1, Day 2, n=6,1	10.977 ( 25.4607 )	12.720 ( 88888 )
IL-8, Session 1, Day 3, predose, n=6,1	6.830 ( 10.6309 )	9.350 ( 88888 )
IL-8, Session 1, Day 3, 1 hour, n=6,0	3.035 ( 6.9193 )	99999 ( 99999 )
IL-8, Session 1, Day 3, 3 hour, n=6,0	-0.788 ( 4.9840 )	99999 ( 99999 )
IL-8, Session 1, Day 3, 6 hour, n=6,0	-0.490 ( 7.3654 )	99999 ( 99999 )
IL-8, Session 1, Day 4, n=6,0	-0.542 ( 5.0480 )	99999 ( 99999 )
IL-8, Session 1, Day 5, n=6,0	1.198 ( 3.0063 )	99999 ( 99999 )
IL-8, Session 2, Day -2, n=6,0	7.848 ( 12.9271 )	99999 ( 99999 )
IL-8, Session 2, Day 1, predose, n=6,0	4.920 ( 8.3853 )	99999 ( 99999 )
IL-8, Session 2, Day 1, 1 hour, n=6,0	1.592 ( 6.9965 )	99999 ( 99999 )
IL-8, Session 2, Day 1, 3 hour, n=6,0	0.275 ( 7.2669 )	99999 ( 99999 )
IL-8, Session 2, Day 1, 6 hour, n=6,0	1.243 ( 6.1976 )	99999 ( 99999 )
IL-8, Session 2, Day 2, n=6,0	5.468 ( 7.5652 )	99999 ( 99999 )
IL-8, Session 2, Day 3, predose, n=6,0	8.322 ( 5.0082 )	99999 ( 99999 )
IL-8, Session 2, Day 3, 1 hour, n=6,0	6.432 ( 10.6402 )	99999 ( 99999 )
IL-8, Session 2, Day 3, 3 hour, n=6,0	-1.107 ( 5.8160 )	99999 ( 99999 )
IL-8, Session 2, Day 3, 6 hour, n=6,0	-0.870 ( 4.6278 )	99999 ( 99999 )
IL-8, Session 2, Day 4, n=6,0	1.667 ( 5.5170 )	99999 ( 99999 )
IL-8, Session 2, Day 5, n=6,0	2.853 ( 5.4769 )	99999 ( 99999 )
IL-8, Session 3, Day -2, n=5,0	12.742 ( 7.8571 )	99999 ( 99999 )
IL-8, Session 3, Day 1, predose, n=6,0	7.635 ( 6.3602 )	99999 ( 99999 )
IL-8, Session 3, Day 1, 1 hour, n=6,0	3.848 ( 5.5264 )	99999 ( 99999 )
IL-8, Session 3, Day 1, 3 hour, n=6,0	-0.517 ( 5.6983 )	99999 ( 99999 )
IL-8, Session 3, Day 1, 6 hour, n=6,0	0.933 ( 8.0166 )	99999 ( 99999 )
IL-8, Session 3, Day 2, n=5,0	3.024 ( 5.5819 )	99999 ( 99999 )
IL-8, Session 3, Day 3, predose, n=6,0	14.440 ( 13.4971 )	99999 ( 99999 )
IL-8, Session 3, Day 3, 1 hour, n=6,0	4.887 ( 5.2130 )	99999 ( 99999 )
IL-8, Session 3, Day 3, 3 hour, n=6,0	0.088 ( 4.3970 )	99999 ( 99999 )
IL-8, Session 3, Day 3, 6 hour, n=6,0	2.450 ( 6.2029 )	99999 ( 99999 )
IL-8, Session 3, Day 4, n=6,0	3.680 ( 4.5662 )	99999 ( 99999 )
IL-8, Session 3, Day 5, n=6,0	7.783 ( 3.9382 )	99999 ( 99999 )
IL-8, Session 4, Day -2, n=5,0	15.686 ( 10.4436 )	99999 ( 99999 )
IL-8, Session 4, Day 1, predose, n=5,0	9.910 ( 11.2178 )	99999 ( 99999 )
IL-8, Session 4, Day 1, 1 hour, n=5,0	10.088 ( 13.7154 )	99999 ( 99999 )
IL-8, Session 4, Day 1, 3 hour, n=5,0	5.242 ( 11.1547 )	99999 ( 99999 )
IL-8, Session 4, Day 1, 6 hour, n=5,0	6.992 ( 12.0857 )	99999 ( 99999 )
IL-8, Session 4, Day 2, n=5,0	4.282 ( 8.9442 )	99999 ( 99999 )
IL-8, Session 4, Day 3, predose, n=5,0	15.072 ( 11.8360 )	99999 ( 99999 )
IL-8, Session 4, Day 3, 1 hour, n=5,0	10.536 ( 8.8924 )	99999 ( 99999 )
IL-8, Session 4, Day 3, 3 hour, n=5,0	1.474 ( 3.3523 )	99999 ( 99999 )
IL-8, Session 4, Day 3, 6 hour, n=5,0	1.208 ( 3.6252 )	99999 ( 99999 )
IL-8, Session 4, Day 4, n=5,0	7.118 ( 14.6164 )	99999 ( 99999 )
IL-8, Session 4, Day 5, n=4,0	-1.795 ( 4.8526 )	99999 ( 99999 )
IL-8, Session 5, Day -2, n=4,0	21.055 ( 14.5161 )	99999 ( 99999 )
IL-8, Session 5, Day 1, predose, n=4,0	18.213 ( 16.0292 )	99999 ( 99999 )
IL-8, Session 5, Day 1, 1 hour, n=4,0	17.667 ( 15.2020 )	99999 ( 99999 )
IL-8, Session 5, Day 1, 3 hour, n=4,0	12.463 ( 16.7548 )	99999 ( 99999 )
IL-8, Session 5, Day 1, 6 hour, n=4,0	5.617 ( 8.7263 )	99999 ( 99999 )
IL-8, Session 5, Day 2, n=4,0	5.463 ( 9.5943 )	99999 ( 99999 )
IL-8, Session 5, Day 3, predose, n=4,0	16.915 ( 13.4207 )	99999 ( 99999 )
IL-8, Session 5, Day 3, 1 hour, n=4,0	9.240 ( 11.0353 )	99999 ( 99999 )
IL-8, Session 5, Day 3, 3 hour, n=4,0	5.902 ( 9.1992 )	99999 ( 99999 )
IL-8, Session 5, Day 3, 6 hour, n=4,0	5.335 ( 7.4134 )	99999 ( 99999 )
IL-8, Session 5, Day 4, n=4,0	7.610 ( 12.4139 )	99999 ( 99999 )
IL-8, Session 5, Day 5, n=4,0	7.330 ( 14.2059 )	99999 ( 99999 )
IL-8, Session 6, Day -2, n=4,0	12.908 ( 11.2540 )	99999 ( 99999 )
IL-8, Session 6, Day 1, predose, n=4,0	17.575 ( 14.9713 )	99999 ( 99999 )
IL-8, Session 6, Day 1, 1 hour, n=4,0	18.718 ( 14.2024 )	99999 ( 99999 )
IL-8, Session 6, Day 1, 3 hour, n=4,0	13.823 ( 18.3486 )	99999 ( 99999 )
IL-8, Session 6, Day 1, 6 hour, n=4,0	12.923 ( 15.0125 )	99999 ( 99999 )
IL-8, Session 6, Day 2, n=4,0	13.338 ( 15.7070 )	99999 ( 99999 )
IL-8, Session 6, Day 3, predose, n=4,0	25.338 ( 17.9965 )	99999 ( 99999 )
IL-8, Session 6, Day 3, 1 hour, n=4,0	11.733 ( 12.1142 )	99999 ( 99999 )
IL-8, Session 6, Day 3, 3 hour, n=4,0	6.853 ( 7.9858 )	99999 ( 99999 )
IL-8, Session 6, Day 3, 6 hour, n=4,0	7.220 ( 9.8022 )	99999 ( 99999 )
IL-8, Session 6, Day 4, n=4,0	13.500 ( 13.0942 )	99999 ( 99999 )
IL-8, Session 6, Day 5, n=4,0	14.130 ( 9.1046 )	99999 ( 99999 )

Notes
[88] - Safety Population
[89] - Safety Population

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

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).

Adverse event reporting additional description

SAEs and non-serious AEs are reported for Safety Population for Group 1 and 2 only as no participant was enrolled in Group-3.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Group 2: Post-chemotherapy AL Amyloidosis participants

Reporting group description

Reporting group title

Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants

Reporting group description

Serious adverse events	Group 2: Post-chemotherapy AL Amyloidosis participants	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 1 (100.00%)	2 / 6 (33.33%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Vascular disorders
Vasculitis
subjects affected / exposed	1 / 1 (100.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac failure
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Transient ischaemic attack
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 2: Post-chemotherapy AL Amyloidosis participants	Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants
Total subjects affected by non serious adverse events
subjects affected / exposed	1 / 1 (100.00%)	6 / 6 (100.00%)
Vascular disorders
Flushing
subjects affected / exposed	0 / 1 (0.00%)	3 / 6 (50.00%)
occurrences all number	0	12
Haemorrhage
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
General disorders and administration site conditions
Catheter site bruise
subjects affected / exposed	1 / 1 (100.00%)	3 / 6 (50.00%)
occurrences all number	1	6
Fatigue
subjects affected / exposed	1 / 1 (100.00%)	3 / 6 (50.00%)
occurrences all number	1	9
Injection site bruising
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	2
Oedema peripheral
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	2
Catheter site dermatitis
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Catheter site erythema
subjects affected / exposed	1 / 1 (100.00%)	0 / 6 (0.00%)
occurrences all number	1	0
Catheter site related reaction
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Feeling cold
subjects affected / exposed	1 / 1 (100.00%)	0 / 6 (0.00%)
occurrences all number	1	0
Oedema
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Peripheral swelling
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Pyrexia
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Secretion discharge
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
Thirst
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
Vessel puncture site bruise
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Reproductive system and breast disorders
Nipple pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 1 (0.00%)	3 / 6 (50.00%)
occurrences all number	0	3
Dyspnoea
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Dyspnoea exertional
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Oropharyngeal pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	2
Investigations
Liver function test increased
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Urine output increased
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Injury, poisoning and procedural complications
Skin laceration
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	4
Arthropod bite
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Limb injury
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Nail injury
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Lip injury
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Thermal burn
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Cardiac disorders
Ventricular tachycardia
subjects affected / exposed	1 / 1 (100.00%)	2 / 6 (33.33%)
occurrences all number	1	33
Cardiac failure
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Palpitations
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Ventricular extrasystoles
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Nervous system disorders
Somnolence
subjects affected / exposed	1 / 1 (100.00%)	2 / 6 (33.33%)
occurrences all number	1	8
Dizziness
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	3
Headache
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	3
Ageusia
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Depressed level of consciousness
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Paraesthesia
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Eye disorders
Dry eye
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Ocular hyperaemia
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Gastrointestinal disorders
Constipation
subjects affected / exposed	1 / 1 (100.00%)	3 / 6 (50.00%)
occurrences all number	1	5
Abdominal discomfort
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Dyspepsia
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	2
Diarrhoea
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Dry mouth
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Rash erythematous
subjects affected / exposed	0 / 1 (0.00%)	3 / 6 (50.00%)
occurrences all number	0	3
Dermatitis contact
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	6
Rash maculo-papular
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	3
Acne
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Dermal cyst
subjects affected / exposed	1 / 1 (100.00%)	0 / 6 (0.00%)
occurrences all number	1	0
Erythema
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Miliaria
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Palmar erythema
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
Post inflammatory pigmentation change
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Pruritus generalised
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Pruritus
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Dysuria
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Urinary retention
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	1 / 1 (100.00%)	1 / 6 (16.67%)
occurrences all number	1	1
Back pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Joint stiffness
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
Joint swelling
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Limb discomfort
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Musculoskeletal stiffness
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Myalgia
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	2
Pain in extremity
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	3
Neck pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Arthralgia
subjects affected / exposed	0 / 1 (0.00%)	2 / 6 (33.33%)
occurrences all number	0	8
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1
Upper respiratory tract infection
subjects affected / exposed	0 / 1 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

20 Apr 2017

Amendment 1: Changes made to reflect regulatory input from the Food and Drug Administration (FDA). Other changes made to correct minor errors included in the original version.

05 Mar 2018

Amendment 2: Regulatory input from the FDA on clarifying requirements for recruitment. Define plasma SAP depletion target level of <3 milligrams per liter. Inclusion criterion for LV mass updated for Groups 2 and 3 to reflect the immunoglobin light chain amyloidosis (AL) participants population. Reflect regulatory safety update information for Gadolinium contrast agents. Dermatology review timings adjusted for grade 3 rash incidences. Other changes made for clarity and to correct minor typographical errors.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in left ventricular (LV) mass over time up to 8-week follow-up

Primary: Change from Baseline in left ventricular (LV) mass over time up to 8-week follow-up

Primary: Number of participants with any on-treatment adverse events (AEs)

Primary: Number of participants with any on-treatment adverse events (AEs)

Primary: Number of participants with any serious adverse events (SAEs)

Primary: Number of participants with any serious adverse events (SAEs)

Primary: Number of participants with abnormal hematology values

Primary: Number of participants with abnormal hematology values

Primary: Number of participants with abnormal clinical chemistry values

Primary: Number of participants with abnormal clinical chemistry values

Primary: Number of participants with abnormal urinalysis results

Primary: Number of participants with abnormal urinalysis results

Primary: Number of participants with abnormal urinalysis results for character parameters

Primary: Number of participants with abnormal urinalysis results for character parameters

Primary: Number of participants with body temperature shifts from Baseline relative to potential clinical importance (PCI) criteria

Primary: Number of participants with body temperature shifts from Baseline relative to potential clinical importance (PCI) criteria

Primary: Number of participants with systolic blood pressure (SBP) and diastolic blood pressure (DBP) shifts from Baseline relative to PCI criteria

Primary: Number of participants with systolic blood pressure (SBP) and diastolic blood pressure (DBP) shifts from Baseline relative to PCI criteria

Primary: Number of participants with pulse rate shifts from Baseline relative to PCI criteria

Primary: Number of participants with pulse rate shifts from Baseline relative to PCI criteria

Primary: Number of participants with abnormal electrocardiogram (ECG) findings

Primary: Number of participants with abnormal electrocardiogram (ECG) findings

Primary: Number of participants with abnormalities during cardiac monitoring

Primary: Number of participants with abnormalities during cardiac monitoring

Primary: Number of participants for which unscheduled echocardiography (ECHO) was performed for safety reasons

Primary: Number of participants for which unscheduled echocardiography (ECHO) was performed for safety reasons

Primary: Number of participants with skin rashes

Primary: Number of participants with skin rashes

Primary: Number of participants with skin rashes classified using CTCAE

Primary: Number of participants with skin rashes classified using CTCAE

Secondary: Number of participants with abnormalities in histopathological examination of skin biopsies

Secondary: Number of participants with abnormalities in histopathological examination of skin biopsies

Secondary: Number of participants with abnormalities in immunohistochemical examination of skin biopsies

Secondary: Number of participants with abnormalities in immunohistochemical examination of skin biopsies

Secondary: Number of participants with abnormalities in histopathological examination of blood biomarkers

Secondary: Number of participants with abnormalities in histopathological examination of blood biomarkers

Secondary: Number of participants with abnormalities in immunohistochemical examination of blood biomarkers

Secondary: Number of participants with abnormalities in immunohistochemical examination of blood biomarkers

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 3 (C3) over time

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 3 (C3) over time

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 4 (C4) over time

Secondary: Change from Baseline in Fluid Phase Complement Marker-Complement 4 (C4) over time

Secondary: Change from Baseline in Fluid Phase Complement Marker-Total Complement (CH50) over time

Secondary: Change from Baseline in Fluid Phase Complement Marker-Total Complement (CH50) over time

Secondary: Change from Baseline in inflammatory biomarkers over time

Secondary: Change from Baseline in inflammatory biomarkers over time

Secondary: Maximum concentration (Cmax) of GSK2398852

Secondary: Maximum concentration (Cmax) of GSK2398852

Secondary: Time associated with Cmax (Tmax) of GSK2398852

Secondary: Time associated with Cmax (Tmax) of GSK2398852

Secondary: Area under the plasma concentration-time curve from time zero to time t (AUC 0-t) of GSK2398852

Secondary: Area under the plasma concentration-time curve from time zero to time t (AUC 0-t) of GSK2398852

Secondary: Cmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: Cmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: Tmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: Tmax of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: AUC 0-t of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: AUC 0-t of GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants

Secondary: Change from Baseline in Global Longitudinal Strain (GLS) by CMR

Secondary: Change from Baseline in Global Longitudinal Strain (GLS) by CMR

Secondary: Change from Baseline in GLS by ECHO

Secondary: Change from Baseline in GLS by ECHO

Secondary: Change from Baseline in LV twist over time

Secondary: Change from Baseline in LV twist over time

Secondary: Change from Baseline in Stroke Volume (SV) by CMR

Secondary: Change from Baseline in Stroke Volume (SV) by CMR

Secondary: Change from Baseline in SV by ECHO

Secondary: Change from Baseline in SV by ECHO

Secondary: Change from Baseline in left ventricular ejection fraction (EF) by CMR

Secondary: Change from Baseline in left ventricular ejection fraction (EF) by CMR

Clinical Trial Results:
A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis