Efficacy Study of Anti-KIR Monoclonal Antibody as Mainten... | NCT01687387

Label	Type	Description	Intervention Names
IPH2102 at 1 mg/kg	Experimental	lirilumab (IPH2102/BMS986015) at 1 mg/kg	Drug: IPH2102 at 1 mg/kg
IPH2102 at 0.1 mg/kg	Experimental	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg	Drug: IPH2102 at 0.1 mg/kg Drug: Placebo (normal saline solution)
Placebo (Normal saline solution)	Placebo Comparator	Normal saline solution	Drug: Placebo (normal saline solution)

Name	Type	Description	Arm Group Labels	Other Names
IPH2102 at 0.1 mg/kg	Drug	every 3 months	IPH2102 at 0.1 mg/kg	lirilumab/BMS986015

Measure	Description	Time Frame
Leukemia-Free Survival		from date of randomization until the date of first documented relapse, assessed up to 48 months

Measure	Description	Time Frame
Number of Participants With Adverse Events	Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs	from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following induction chemotherapy and who received 1 or 2 consolidation cycles. Induction chemotherapy should be performed within 6 months before randomization. Consolidation cycle is defined as any chemotherapy administered within 3 months following CR and including aracytine irrespective of the administered dose(s). A minimum of one and maximum of 2 cycles should be administered before enrollment
Patients not eligible for an allogeneic hematopoietic cell transplantation
Age 60 to 80
ECOG Performance status of 0 or 1
Clinical laboratory values at screening
- Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2
- Platelet > 75 x 109/l
- Hemoglobin ≥ 10 g/dl supported or unsupported by transfusions
- ANC > 1 x 109/l
- Total Bilirubin levels ≤ 1.5 ULN
- ALT and AST ≤ 3 ULN
Recovery from acute toxicity of previous anti-tumor therapy
Male patients who accept and are able to use contraception methods recognized as highly effective.
Signed informed consent prior to any protocol specific procedure.

Exclusion Criteria:

Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)
Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and their molecular equivalents (AML-ETO and CBFB-MYH11)
Last consolidation completed more than 3 months prior to first dosing
Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids
Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment
History of allogeneic hematopoietic cell transplantation or solid organ transplantation
History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML
Use of any investigational agent within 2 months prior to the first dosing
Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing
Any irradiation within the last 3 months except for analgesic intent
Intermittent or continuous renal replacement therapy
Abnormal cardiac status with any of the following
- Ejection fraction (measured by ultra-sound or radionuclide imaging) <50%
- Myocardial infarction within the previous 6 months
- QTc ≥ 480 ms (Bazett's).
Current active infectious disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs Antibody
Auto-immune disease:
- Which currently or previously required systemic immunosuppressive or immuno-modulatory therapy (including corticosteroids administered by systemic route)
- And/or has substantial probability to cause an irreversible injury to any tissue
- And/or is recent or unstable or has substantial risk to progress and cause severe complications.
Serious concurrent uncontrolled medical disorder
History of another malignancy (apart from myelodysplastic syndromes, basal cell carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for ≥ 3 years
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Name	Affiliation	Role
Norbert Vey, MD	Institut Paoli Calmettes Marseille France	Principal Investigator
Hervé Dombret, MD	ALFA cooperative Group	Study Chair
Norbert Ifrah, MD	GOELAMS Cooperative Group	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
CHU d'Amiens		Amiens		80054	France
CHU Angers

ID	Title	Description
FG000	IPH2102 at 1 mg/kg	lirilumab (IPH2102/BMS986015) at 1 mg/kg IPH2102 at 1 mg/kg: every 4 weeks
FG001	IPH2102 at 0.1 mg/kg	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg IPH2102 at 0.1 mg/kg: every 3 months Placebo (normal saline solution): every 4 weeks

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

Leukemia-Free Survival

Posted

Median

95% Confidence Interval

MONTHS

from date of randomization until the date of first documented relapse, assessed up to 48 months

ID	Title	Description
OG000	IPH2102 at 1 mg/kg	lirilumab (IPH2102/BMS986015) at 1 mg/kg IPH2102 at 1 mg/kg: every 4 weeks
OG001	IPH2102 at 0.1 mg/kg	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg IPH2102 at 0.1 mg/kg: every 3 months Placebo (normal saline solution): every 4 weeks
OG002	Placebo (Normal Saline Solution)	Normal saline solution Placebo (normal saline solution): every 4 weeks

Units	Counts
Participants	OG00051 OG00150 OG00251

Title

Denominators

Categories

Title	Measurements
	OG0006.7(2.9 to 14.8) OG00117.6(11.2 to 25) OG00213.9(7.9 to 27.9)

Secondary

Number of Participants With Adverse Events

Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs

Posted

Count of Participants

Participants

from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months

ID	Title	Description
OG000	IPH2102 at 1 mg/kg	lirilumab (IPH2102/BMS986015) at 1 mg/kg IPH2102 at 1 mg/kg: every 4 weeks
OG001	IPH2102 at 0.1 mg/kg	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg IPH2102 at 0.1 mg/kg: every 3 months Placebo (normal saline solution): every 4 weeks
OG002	Placebo (Normal Saline Solution)	Normal saline solution Placebo (normal saline solution): every 4 weeks

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0022 events2 affected51 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Hydrocele	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Chorioretinal disorder	Eye disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Abdominal wall haematoma	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Umbilical hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Fatigue	General disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
General physical health deterioration	General disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected50 at risk EG0020 events0 affected51 at risk
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Anal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Device related infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Peritonitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Sialoadenitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Staphylococcal sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Injury corneal	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Biopsy spleen	Investigations	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected50 at risk EG0022 events2 affected51 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Myxofibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Suicide attempt	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0020 events0 affected51 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0021 events1 affected51 at risk
Respiratory therapy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0020 events0 affected51 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0015 events5 affected50 at risk EG0023 events2 affected51 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0009 events4 affected51 at risk EG0015 events4 affected50 at risk EG00211 events5 affected51 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0009 events9 affected51 at risk EG00111 events7 affected50 at risk EG0024 events3 affected51 at risk
Conjunctivitis	Eye disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0010 events0 affected50 at risk EG0022 events2 affected51 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0014 events3 affected50 at risk EG0024 events2 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0023 events3 affected51 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0004 events2 affected51 at risk EG0015 events5 affected50 at risk EG0023 events3 affected51 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0008 events7 affected51 at risk EG0016 events6 affected50 at risk EG0022 events2 affected51 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected50 at risk EG0024 events4 affected51 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected51 at risk EG0016 events6 affected50 at risk EG0023 events3 affected51 at risk
Asthenia	General disorders	Systematic Assessment	EG00020 events14 affected51 at risk EG00119 events14 affected50 at risk EG00222 events14 affected51 at risk
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0014 events4 affected50 at risk EG0022 events2 affected51 at risk
Chills	General disorders	Systematic Assessment	EG0005 events4 affected51 at risk EG0014 events3 affected50 at risk EG0022 events1 affected51 at risk
Fatigue	General disorders	Systematic Assessment	EG0005 events5 affected51 at risk EG0012 events2 affected50 at risk EG0024 events3 affected51 at risk
Influenza like illness	General disorders	Systematic Assessment	EG0002 events2 affected51 at risk EG0015 events4 affected50 at risk EG0029 events5 affected51 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events2 affected50 at risk EG0023 events3 affected51 at risk
Pyrexia	General disorders	Systematic Assessment	EG0006 events6 affected51 at risk EG0013 events3 affected50 at risk EG0025 events5 affected51 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0009 events6 affected51 at risk EG00120 events17 affected50 at risk EG00215 events14 affected51 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected51 at risk EG0015 events4 affected50 at risk EG0024 events3 affected51 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected51 at risk EG0016 events6 affected50 at risk EG0027 events6 affected51 at risk
Oral herpes	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected50 at risk EG0023 events3 affected51 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected50 at risk EG0021 events1 affected51 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected50 at risk EG0022 events2 affected51 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0004 events2 affected51 at risk EG0018 events2 affected50 at risk EG0027 events5 affected51 at risk
Lipase increased	Investigations	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected50 at risk EG0020 events0 affected51 at risk
Weight increased	Investigations	Systematic Assessment	EG0001 events1 affected51 at risk EG0016 events5 affected50 at risk EG0026 events6 affected51 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0016 events6 affected50 at risk EG0025 events5 affected51 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected50 at risk EG0023 events3 affected51 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0017 events6 affected50 at risk EG0028 events7 affected51 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events2 affected50 at risk EG0023 events3 affected51 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0014 events4 affected50 at risk EG0022 events2 affected51 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected50 at risk EG0024 events4 affected51 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected50 at risk EG0026 events5 affected51 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected51 at risk EG0011 events1 affected50 at risk EG0026 events6 affected51 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0009 events8 affected51 at risk EG0019 events4 affected50 at risk EG0025 events3 affected51 at risk
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0002 events2 affected51 at risk EG0014 events3 affected50 at risk EG0021 events1 affected51 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0019 events6 affected50 at risk EG0021 events1 affected51 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 events1 affected51 at risk EG0013 events3 affected50 at risk EG0020 events0 affected51 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0004 events4 affected51 at risk EG0012 events2 affected50 at risk EG0023 events3 affected51 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected51 at risk EG0012 events2 affected50 at risk EG0025 events3 affected51 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected51 at risk EG0011 events1 affected50 at risk EG0021 events1 affected51 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected50 at risk EG0023 events3 affected51 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected51 at risk EG0013 events3 affected50 at risk EG0023 events3 affected51 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0009 events8 affected51 at risk EG00111 events10 affected50 at risk EG00212 events7 affected51 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0002 events2 affected51 at risk EG0016 events5 affected50 at risk EG0024 events2 affected51 at risk

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	IPH2102 at 1 mg/kg	lirilumab (IPH2102/BMS986015) at 1 mg/kg IPH2102 at 1 mg/kg: every 4 weeks
BG001	IPH2102 at 0.1 mg/kg	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg IPH2102 at 0.1 mg/kg: every 3 months Placebo (normal saline solution): every 4 weeks
BG002	Placebo (Normal Saline Solution)	Normal saline solution Placebo (normal saline solution): every 4 weeks
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IPH2102 at 1 mg/kg	lirilumab (IPH2102/BMS986015) at 1 mg/kg IPH2102 at 1 mg/kg: every 4 weeks	32	51	12	51	38	51
EG001	IPH2102 at 0.1 mg/kg	lirilumab (IPH2102/BMS986015) at 0.1 mg/kg IPH2102 at 0.1 mg/kg: every 3 months Placebo (normal saline solution): every 4 weeks	26	50	17	50	48	50
EG002	Placebo (Normal Saline Solution)	Normal saline solution Placebo (normal saline solution): every 4 weeks	23	51	11	51	43	51