A Study Evaluating the Efficacy, Safety, Pharmacokinetics... | NCT04654468

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crovalimab	Experimental	Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.	Drug: Crovalimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crovalimab	Drug	Crovalimab will be administered at a dose of 1000 milligrams (mg) IV (for participants with body weight between 40 and 100 kg) or 1500 mg IV (for participants with body weight ≥ 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100 kg) or 1020 mg SC (for participants with body weight ≥ 100 kg). Dosing schedule will be as described above.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Percentage of Participants With Hemolysis Control	A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by lactate dehydrogenase (LDH) ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. The dependent variable was the binary indicator for hemolysis control. Independent variables are categorical effects of visits, continuous baseline LDH.	From Week 5 up to Week 25
Difference in Percentage of Participants With Transfusion Avoidance (TA) From Baseline Through Week 25 and Within 24 Weeks Prior to Screening	TA was defined as participants who were packed red blood cell (pRBC) transfusion-free and did not require transfusion per protocol-specified guidelines. TA within 24 weeks prior to screening was based on the pRBC transfusion history in the medical records. Reported in this outcome measure is the difference in the percentage of participants between "baseline through Week 25" and "within 24 weeks prior to screening". 95% Confidence Interval (CI) for the difference between the percentage of participants with transfusion avoidance between Pre-screening and Post-baseline is calculated using the Newcombe method. Screening= Day -28 to Day -1 and Baseline= Day 1.	24 Weeks Prior to Screening, Baseline to Week 25

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Breakthrough Hemolysis (BTH)	BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin < 10 grams per deciliter (g/dL)], major adverse vascular event [MAVE, including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to have experienced a BTH event. Percentages have been rounded off to the first decimal point.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body weight ≥ 40 kg at screening
Willingness and ability to comply with all study visits and procedures
Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry
LDH Levels ≥ 2x the ULN at screening
Participants who have at least four transfusions during 12 months prior to screening (documented in the medical record)
Presence of one or more of the PNH-related signs or symptoms within 3 months of screening
Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment (Day 1)
Vaccination against Haemophilius influenzae type B and Streptococcus pneumonia according to national vaccination recommendations
For participants receiving other therapies (e.g., immunosuppressants, corticosteroids): stable dose for ≥ 28 days prior to screening and up to the first drug administration
Adequate hepatic and renal function
Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of crovalimab
Platelet count ≥30,000 per cubic millimeter (mm^3) at screening
ANC > 500/microlitres (μl) at screening

Exclusion Criteria:

Current or previous treatment with a complement inhibitor
History of allogeneic bone marrow transplantation
History of Neisseria meningitidis infection within 6 months prior to screening and up to first drug administration
Known or suspected immune or hereditary complement deficiency
Known HIV infection with cluster of differentiation 4 (CD4) count < 200 cells/µl within 24 weeks prior to screening
Infection requiring hospitalization or treatment with IV antibiotics within 28 days prior to screening and up to the first drug administration, or oral antibiotics within 14 days prior to screening and up to the first drug administration
Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration
Presence of fever (≥ 38˚C) within 7 days before the first drug administration
Splenectomy < 6 months before screening
History of malignancy within 5 years prior to screening and up to the first drug administration
Pregnant or intending to become pregnant during the study or within 46 weeks (10.5 months) after the final dose of study treatment
Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital, Sichuan University		Chengdu		610041	China
Guangdong General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39535306	Derived	Roth A, Fu R, He G, Alzahrani H, Chou SC, Hicheri Y, Kazmierczak M, Recova VL, Uchiyama M, Vladareanu AM, Beveridge L, Buatois S, Buri M, Compagno N, Shi D, Balachandran N, Sreckovic S, Scheinberg P. Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH): Pooled Results From the Phase 3 COMMODORE Studies. Eur J Haematol. 2025 Feb;114(2):373-382. doi: 10.1111/ejh.14339. Epub 2024 Nov 13.
37421604

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 milligrams (mg) (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight >=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) once every 4 weeks (Q4W) from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab Q4W.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 23, 2022	Mar 29, 2023

Arm/Group Information

ID	Title	Description
BG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Units	Counts
Participants	BG00051

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
	BG00033.0± 9.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00029
Male	BG00022

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG00051

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG00051

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

Mean Percentage of Participants With Hemolysis Control

A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by lactate dehydrogenase (LDH) ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. The dependent variable was the binary indicator for hemolysis control. Independent variables are categorical effects of visits, continuous baseline LDH.

Primary Analysis Population (PAP) included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.

Posted

Least Squares Mean

95% Confidence Interval

mean percentage of participants

From Week 5 up to Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Units	Counts
Participants	OG00051

Title

Denominators

Categories

Title	Measurements
	OG00078.66(67.78 to 86.59)

Primary

Difference in Percentage of Participants With Transfusion Avoidance (TA) From Baseline Through Week 25 and Within 24 Weeks Prior to Screening

TA was defined as participants who were packed red blood cell (pRBC) transfusion-free and did not require transfusion per protocol-specified guidelines. TA within 24 weeks prior to screening was based on the pRBC transfusion history in the medical records. Reported in this outcome measure is the difference in the percentage of participants between "baseline through Week 25" and "within 24 weeks prior to screening". 95% Confidence Interval (CI) for the difference between the percentage of participants with transfusion avoidance between Pre-screening and Post-baseline is calculated using the Newcombe method.

Screening= Day -28 to Day -1 and Baseline= Day 1.

PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.

Posted

Number

95% Confidence Interval

percentage of participants

24 Weeks Prior to Screening, Baseline to Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Secondary

Percentage of Participants With Breakthrough Hemolysis (BTH)

BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin < 10 grams per deciliter (g/dL)], major adverse vascular event [MAVE, including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to have experienced a BTH event. Percentages have been rounded off to the first decimal point.

PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Secondary

Percentage of Participants With Stabilized Hemoglobin

Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to not have hemoglobin stabilization.

PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Units	Counts
Participants

Secondary

Change From Baseline in Fatigue in Adults Aged >=18 Years

Fatigue was assessed using functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. FACIT-F is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Items are scored on a response scale that ranges from 0 ("not at all") to 4 ("very much so"). Relevant items are reverse scored, and all the items are summed to create a total score range from 0 to 52, with 0 being the worst possible score and 52 being the best possible score. A higher score indicates low fatigue severity. A positive mean change indicates improvement. FACIT-F was assessed in adult participants only. FACIT-F assessment was unintentionally missed in the Schedule of Activities (SoA) table, which site used to guide the assessments at each timepoint. Therefore, data were not collected at Week 25.

PAP included all enrolled participants who received at least one dose of crovalimab and had at least one central LDH level assessment after the first IV infusion. Overall number analyzed is the number of participants ≥18 years with data available for analysis.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 2, Week 5, Week 9, Week 17, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Secondary

Percentage of Participants With Adverse Events (AEs)

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Percentage of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, and Infections (Including Meningococcal Meningitis)

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Trough Serum Concentration of Crovalimab Over Time

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Serum Concentrations of Crovalimab

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Terminal Complement Activity as Measured by Liposome Immunoassay (LIA)

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Change Over Time in Total and Free C5 Concentration

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Observed Value in Absolute Reticulocyte Count

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Observed Value in Free Hemoglobin

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Observed Value in Haptoglobin

Not Posted

Feb 2029

Up to 7 years

Participants

Secondary

Percent Change From Baseline in Absolute Reticulocyte Count

Safety population included all enrolled participants who received at least one dose of crovalimab. Number of participants analyzed is the number of participants with data available for analysis at the specified timepoints.

Posted

Mean

Standard Deviation

percent change

Baseline, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Free Hemoglobin

Posted

Mean

Standard Deviation

percent change

Baseline, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Haptoglobin

Posted

Mean

Standard Deviation

percent change

Baseline, Week 25

ID	Title	Description
OG000	Crovalimab	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.

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	CROVALIMAB	Crovalimab was administered at an initial loading dose of 1000 mg (for participants with body weight between 40 and 100) kg or 1500 mg (for participants with body weight >=100kg), as IV injection on Day 1 of Week 1 followed by four weekly SC injections of 340 mg starting on Day 2 of Week 1 and then QW at Weeks 2,3 and 4. Thereafter crovalimab was administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) Q4W from Week 5 for a total of 24 weeks of study treatment. Participants who derive benefit from the drug after 24 weeks of treatment may continue to receive crovalimab.	1	51	4	51	46	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk
Abdominal wall mass	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk
Bacteraemia	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk
Platelet count decreased	Investigations	MedDRA version 24.1	Systematic Assessment	EG0001 events1 affected51 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA version 24.1	Systematic Assessment	EG0008 events7 affected51 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA version 24.1	Systematic Assessment	EG0003 events3 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG00026 events24 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA version 24.1	Systematic Assessment	EG0004 events3 affected51 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00015 events11 affected51 at risk
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG0008 events8 affected51 at risk
Bilirubin conjugated increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00027 events15 affected51 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00012 events9 affected51 at risk
Blood bilirubin increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00010 events9 affected51 at risk
Blood bilirubin unconjugated increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00013 events12 affected51 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG0009 events6 affected51 at risk
Lymphocyte count decreased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00015 events8 affected51 at risk
Neutrophil count decreased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00025 events13 affected51 at risk
Platelet count decreased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00010 events5 affected51 at risk
Weight increased	Investigations	MedDRA version 24.1	Systematic Assessment	EG0006 events6 affected51 at risk
White blood cell count decreased	Investigations	MedDRA version 24.1	Systematic Assessment	EG00029 events12 affected51 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0005 events3 affected51 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG00016 events5 affected51 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA version 24.1	Systematic Assessment	EG0007 events5 affected51 at risk

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