A Study to Evaluate the Efficacy and Safety of Pegcetacop... | NCT04085601

NCT04085601

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Standard of Care (SOC) excluding complement inhibitors	No Intervention
1,080mg APL-2 administered subcutaneously twice weekly	Experimental		Drug: APL-2

Name	Type	Description	Arm Group Labels	Other Names
APL-2	Drug	Complement (C3) Inhibitor	1,080mg APL-2 administered subcutaneously twice weekly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Who Achieved Hemoglobin (Hb) Stabilization	The Hb stabilization was defined as avoidance of a >1 gram per deciliter (g/dL) decrease in Hb concentration from Baseline in the absence of transfusion through Week 26.	From Baseline (Day 1) up to Week 26
Change From Baseline in Lactate Dehydrogenase (LDH) Concentration At Week 26	The LDH concentration was analyzed using an analysis of covariance (ANCOVA) model with a last observation carried forward (LOCF) and a baseline observation carried forward (BOCF) approach for handling missing data. Baseline was defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.	Baseline (Day 1) and Week 26

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With an Hb Response in the Absence of Transfusions	An Hb response was defined as a =>1 g/dL increase in Hb from baseline at Week 26.	Baseline and Week 26
Change From Baseline in Absolute Reticulocyte Count (ARC) at Week 26

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Julian Coronel Medical Center		Cali			Colombia
Research Center of the Colombian Clinical Life Cancer Foundation

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40720060	Derived	de Castro C, Kelly RJ, Griffin M, Patriquin CJ, Mulherin B, Hochsmann B, Selvaratnam V, Wong RSM, Hillmen P, Horneff R, Uchendu UO, Zhang Y, Surova E, Szamosi J, de Latour RP. Efficacy and Safety Maintained up to 3 Years in Adults with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan. Adv Ther. 2025 Sep;42(9):4641-4658. doi: 10.1007/s12325-025-03310-8. Epub 2025 Jul 28.
39079163

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pegcetacoplan	Subjects were received subcutaneous (SC) infusion of pegcetacoplan 1080 milligram (mg) twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
FG001	Standard of Care

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 10, 2020	Aug 18, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Blood samples were collected via direct venipuncture at the specific time points to determine ARC. Baseline was defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.

The intent-to-treat (ITT) set included all subjects assigned to treatment.

Arm/Group Information

ID	Title	Description
BG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 milligram (mg) twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
BG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.2± 12.70 BG00149.1± 15.64 BG00244.5± 14.00

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG00033 BG00114 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG0018 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Black or African American	BG0002 BG0010 BG002

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

Number of Subjects Who Achieved Hemoglobin (Hb) Stabilization

The Hb stabilization was defined as avoidance of a >1 gram per deciliter (g/dL) decrease in Hb concentration from Baseline in the absence of transfusion through Week 26.

The ITT set included all subjects assigned to treatment.

Posted

Count of Participants

Participants

From Baseline (Day 1) up to Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG00035 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00030 OG0010

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		Cochran-Mantel-Haenszel		<0.0001	Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (<4, ≥ 4) reported in electronic data capture (EDC) data.	Difference	0.7311			2-Sided	95	0.572	0.8902					Superiority

Primary

Change From Baseline in Lactate Dehydrogenase (LDH) Concentration At Week 26

The LDH concentration was analyzed using an analysis of covariance (ANCOVA) model with a last observation carried forward (LOCF) and a baseline observation carried forward (BOCF) approach for handling missing data. Baseline was defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

Units/Liter (U/L)

Baseline (Day 1) and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts

Secondary

Number of Subjects With an Hb Response in the Absence of Transfusions

An Hb response was defined as a =>1 g/dL increase in Hb from baseline at Week 26.

The ITT set included all subjects assigned to treatment.

Posted

Count of Participants

Participants

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Absolute Reticulocyte Count (ARC) at Week 26

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

10^9 cells/L

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants

Secondary

Change From Baseline in Hb Concentration at Week 26

Baseline was defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

g/dL

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Who Received Transfusion or Decrease of Hb >2 g/dL From Baseline

Transfusion refers to any transfusion of PRBC, leukocyte-depleted red blood cells (LDPRC), leukocyte poor packed red blood cell (LPRC), leukocyte poor blood (LPB) or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Transfusion Avoidance

Transfusion avoidance was defined as the percentage of subjects who did not require a transfusion during the RCP. Transfusion refers to any transfusion of PRBC, LDPRC, LPRC, LPB or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Number of PRBC Units Transfused From Baseline Through Week 26

The number of units of PRBC transfusions was estimated. In one transfusion subjects received one or more units.

The ITT set included all subjects assigned to treatment.

Posted

Median

Full Range

PRBC transfusions

Up to Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Functional Assessment of Chronic Illness Therapy- (FACIT-Fatigue) Scale Score at Week 26

The FACIT-Fatigue Scale is a 13-item Likert scaled instrument that is self-administered by the subjects during clinic visits. Subjects were presented with 13 statements and asked to indicate their responses as it applied to the past 7 days. The 5 possible responses are "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), and "Very much" (4). With 13 statements, the total score has a range of 0 to 52. The higher score corresponded to a higher quality of life. Baseline is defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Secondary

Percentage of Subjects With Hb Normalization Levels at Week 26

Normalization of Hb levels defined as >= 1x LLN at Week 26 in the absence of transfusion. Transfusion refers to any transfusion of PRBC, LDPRC, LPRC, LPB or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Number

percentage of subjects

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With LDH Normalization at Week 26

The LDH normalization was defined as LDH <= 1xupper limit of normal (ULN) of normal range at week 26 in the absence of transfusion. Transfusion refers to any transfusion of PRBC, LDPRC, LPPRC, LPRC, LPB or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30) Scores at Week 26

The EORTC QLQ-C30 questionnaire (version 3.0) consisted of 30 questions comprised of both multi-item scales and single-item measures to assess overall quality of life in subjects. Questions were designated by functional scales, symptom scales, and global subject QOL/overall perceived health status. For the first 28 questions the 4 possible responses are "Not at all' (1), 'A little' (2), 'Quite a bit' (3) and 'Very much' (4). For the remaining 2 questions the response is requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). Each scale has a range of 0% - 100%. A high scale score represents a higher response level. Baseline is defined as average of measurements prior to first dose of pegcetacoplan or on or prior to randomization of SoC. Post baseline missing values are imputed using multiple imputation method with Markov Chain Mont Carlo method.

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Secondary

Change From Baseline in Linear Analog Assessment (LASA) Scales Score at Week 26

The LASA consisted of 3 items asking respondents to rate their perceived level of functioning. Specific domains include activity level, ability to carry out daily activities, and an item for overall QOL. Their level of functioning was reported on a 0-100 scale with 0 representing "As low as could be" and 100 representing "As high as could be".

The ITT set included all subjects assigned to treatment.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants

Secondary

Percentage of Subjects With ARC Normalization

Absolute reticulocyte count normalization is defined as ARC < 1x ULN of the gender-specific normal range at week 26 in the absence of transfusion. Subjects who received a transfusion or withdraw from study or escaped from SoC to pegcetacoplan treatment group or lost to follow up without providing efficacy data at Week 26 were classified as non-responders. Transfusion refers to any transfusion of PRBC, LDPRC, LPRC, LPB or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants

Secondary

Number of Subjects With Failure of Hb Stabilization

Hb stabilization is defined as avoidance of a >1 g/dL decrease in Hb levels from baseline through Week 26 in the absence of transfusion. Transfusion refers to any transfusion of PRBC, LDPRC, LPRC, LPB or whole blood.

The ITT set included all subjects assigned to treatment.

Posted

Count of Participants

Participants

Up to Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Secondary

Time to First PRBC Transfusion

Time to first-on-study PRBC transfusions during RCP were reported. Here NA indicates not estimable.

The ITT set included all subjects assigned to treatment.

Posted

Median

95% Confidence Interval

weeks

Up to Week 26

ID	Title	Description
OG000	Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors.
OG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Overall Pegcetacoplan	Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors. During the study, any subject assigned to the SoC reporting group (excluding complement inhibitors) who had an Hb concentration >=2 g/dL below baseline or who presented with a qualifying thromboembolic event secondary to PNH was offered early escape therapy with pegcetacoplan.	1	46	6	46	35	46
EG001	Standard of Care	Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy.	1	18	3	18	12	18

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Herpes virus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected18 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected46 at risk EG0010 events0 affected18 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events1 affected18 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected46 at risk EG0010 events0 affected18 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected46 at risk EG0010 events0 affected18 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0012 events2 affected18 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected46 at risk EG0012 events2 affected18 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0011 events1 affected18 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected46 at risk EG0010 events0 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0009 events5 affected46 at risk EG0010 events0 affected18 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 events3 affected46 at risk EG0010 events0 affected18 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected46 at risk EG0011 events1 affected18 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected18 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00010 events5 affected46 at risk EG0010 events0 affected18 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0009 events4 affected46 at risk EG0010 events0 affected18 at risk
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected46 at risk EG0010 events0 affected18 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected18 at risk

First MCP Posted Date

ID	Term
D006457	Hemoglobinuria, Paroxysmal

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