A Study Evaluating the Efficacy and Safety of ABP 959 Com... | NCT03818607

Label	Type	Description	Intervention Names
T (ABP 959) / R (eculizumab)	Other	ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2	Drug: ABP 959 Drug: Eculizumab
R (eculizumab) / T (ABP 959)	Other	Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2	Drug: ABP 959 Drug: Eculizumab

Name	Type	Description	Arm Group Labels	Other Names
ABP 959	Drug	intravenous infusion	R (eculizumab) / T (ABP 959) T (ABP 959) / R (eculizumab)

Measure	Description	Time Frame
LDH Level at Week 27 (Parallel Comparison)	The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).	Week 27
Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.	From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79

Measure	Description	Time Frame
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children's Healthcare of Atlanta at Egleston		Atlanta	Georgia	30322	United States
Fakultní Nemocnice Brno

PubMed Identifier	Type	Citation	Retractions
39171864	Derived	Kulasekararaj A, Lanza F, Arvanitakis A, Langemeijer S, Chonat S, Tombak A, Hanes V, Cao J, Miller MJ, Colbert A, Shander B, Mytych DT, Chow V, Henary H. Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria. Am J Hematol. 2024 Nov;99(11):2108-2117. doi: 10.1002/ajh.27456. Epub 2024 Aug 22.

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered intravenously (IV) every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
FG001	Eculizumab/ABP 959

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 5, 2020	Mar 23, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

LDH Level at Week 27 (Parallel Comparison)

The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).

The full analysis set (FAS) included all randomized participants.

Posted

Geometric Least Squares Mean

95% Confidence Interval

U/L

Week 27

ID	Title	Description
OG000	ABP 959	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
OG001	Eculizumab	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.

Units	Counts
Participants	OG00020 OG00122

Title

Denominators

Categories

Title	Measurements
	OG000205.69(191.23 to 221.24) OG001193.53(180.80 to 207.17)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Geometric LS mean ratio (GMR)	1.0628			1-Sided	97.5		1.1576					Non-Inferiority	The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.

Primary

Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)

The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.

The modified FAS included all randomized participants with an LDH-time profile evaluable for the time-adjusted AUEC, according to treatment assigned during each of the 14-week assessments during Period 1 and 2.

Posted

Geometric Least Squares Mean

95% Confidence Interval

U*day/L/week

From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79

ID	Title	Description
OG000	ABP 959	Participants who received ABP 959 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or ABP 959 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).
OG001	Eculizumab	Participants who received eculizumab 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or eculizumab 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).

Units	Counts
Participants

Secondary

Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])

Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%.

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

Percent of LLN for all CH50 values

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts

Secondary

Mean Total Hemoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

g/L

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants	OG000

Secondary

Mean Serum-free Hemoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants	OG000

Secondary

Mean Haptoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

g/L

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants	OG000

Secondary

Mean Bilirubin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

micromol/L

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants	OG000

Secondary

Degree of Hemoglobinuria

The degree of hemoglobinuria was categorized as negative, trace, small, moderate, and large based on the analysis of urine samples collected from each participant at the specified time points.

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with evaluable urine samples available at each time point. The FAS included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants

Secondary

Mean Percentage of Type III Erythrocytes

As a measure of hemolysis the mean percentage of Type III erythrocytes was measured at the specified timepoints.

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

Percentage of Type III Erythrocytes

Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants

Secondary

LDH Levels at Week 53 and Week 79

The analysis of the crossover comparison of hemolysis, as measured by LDH at Week 53 and Week 79.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Geometric Least Squares Mean

95% Confidence Interval

U/L

Week 53 (first week of Period 2) and Week 79 (last week of Period 2)

ID	Title	Description
OG000	ABP 959	Participants who received ABP 959 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or ABP 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).
OG001	Eculizumab	Participants who received eculizumab 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or eculizumab 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).

Units	Counts
Participants	OG000

Secondary

Mean LDH Levels by Visit up to Week 79

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

U/L

Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants

Secondary

Mean Number of Packed RBC Units Transfused Per Month

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Participants in the FAS who had packed RBC units transfused. The FAS included all randomized participants.

Posted

Mean

Standard Deviation

packed RBC units per month

Baseline to End of Study (up to Week 79)

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered intravenously (IV) every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg every 14 ± 2 days for 26 weeks in Period 2.

Units	Counts
Participants	OG000

Secondary

Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)

The total and unbound PK concentration AUC values from Week 13 to Week 15 in Period 1 are presented by actual treatment received.

The PK parameter analysis set consisted of a subset of participants from the safety analysis set with an evaluable ABP 959 or eculizumab serum concentration time profile from Week 13 to Week 15.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg*day/mL

PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15

ID	Title	Description
OG000	ABP 959	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
OG001	Eculizumab	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.

Units	Counts
Participants

Secondary

Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab

The total and unbound serum trough concentrations are presented by treatment sequence received for the prespecified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

The PK concentration analysis set consisted of a subset of participants from the safety analysis set with at least one serum concentration (including results below the quantifiable limit) of ABP 959 or eculizumab, with data analyzed according to actual treatment received. Participants with data available at each time point are presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered intravenously (IV) every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg every 14 ± 2 days for 26 weeks in Period 2.

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs are defined as any adverse event (AE) that began or increased in severity or frequency at or after the time of first treatment up to end of study (up to Week 79). A treatment-emergent serious adverse event (SAE) was a TEAE that met at least 1 of the following criteria: was fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another medically important serious event.

The treatment-emergent events of interest (EOI) prespecified for this study included serious infections (meningococcus aspergillus, and other serious infections/sepsis), and infusion reactions.

The safety analysis set included all treated participants, with treatment assigned based on actual treatment received.

Posted

Count of Participants

Participants

Day 1 to End of Study (up to Week 79)

ID	Title	Description
OG000	ABP 959	Participants who received ABP 959 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or ABP 959 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).
OG001	Eculizumab	Participants who received eculizumab 900 mg in Period 1 (administered IV every 14 ± 2 days for 52 weeks) or eculizumab 900 mg in Period 2 (administered IV every 14 ± 2 days for 26 weeks).

Secondary

Number of Participants With Antidrug Antibodies (ADAs)

Any samples that tested positive for binding antibodies were also tested for neutralizing antibodies. Treatment boosted ADAs were defined as a positive immunoassay result at baseline and at least 1 postbaseline immunoassay result that was ≥ 4 times the magnitude of the baseline result. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

The safety analysis set included all treated participants, with treatment assigned based on actual treatment received.

Posted

Count of Participants

Participants

Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79.

ID	Title	Description
OG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
OG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected20 at risk EG0014 affected22 at risk EG0023 affected21 at risk EG0031 affected20 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected21 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0022 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0022 affected21 at risk EG003
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Eye pruritus	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected21 at risk EG003
Neovascular age-related macular degeneration	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0022 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected21 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0022 affected21 at risk EG003
Catheter site pruritus	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Chills	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0022 affected21 at risk EG003
Influenza like illness	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected20 at risk EG0011 affected22 at risk EG0023 affected21 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Ocular icterus	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0023 affected21 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Enterovirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Gingivitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Lyme disease	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0005 affected20 at risk EG0012 affected22 at risk EG0024 affected21 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0015 affected22 at risk EG0022 affected21 at risk EG003
C-reactive protein increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Vitamin D decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Weight increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0022 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected20 at risk EG0019 affected22 at risk EG0022 affected21 at risk EG003
Migraine	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Somnolence	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Vertigo CNS origin	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Bilirubinuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Haemoglobinuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0013 affected22 at risk EG0022 affected21 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Sinonasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected21 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected21 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0021 affected21 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected21 at risk EG003
Flushing	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected20 at risk EG0015 affected22 at risk EG0020 affected21 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected21 at risk EG003

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009190	Myelodysplastic Syndromes
D001855	Bone Marrow Diseases

ID	Title	Description
BG000	ABP 959/Eculizumab	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
BG001	Eculizumab/ABP 959	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Period 1: ABP 959	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	20	3	20	15	20
EG001	Period 1: Eculizumab	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	22	1	22	20	22
EG002	Period 2: ABP 959	Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.	21	4	21	17	21
EG003	Period 2: Eculizumab	Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.	20	1	20	18	20