2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
付録
1
参考文献Gonzalez-Suarez E, Jacob AP, Jones J, et al. RANK ligand mediates progestin-induced mammary epithelial proliferation and carcinogenesis. Nature. 2010;468(7320):103-7.
Malawer MM, Helman LJ, O’Sullivan B. Sarcomas of the Soft Tissues and Bone - Chapter 45.2. In:
Devita VT Jr, Lawrence TS, Rosenberg SA, editors. Cancer: Principles and Practice of Oncology, 8th ed. Lippincott Williams and Wilkins; 2005. p. 1794-833.
Medical Dictionary Regulatory Activities Maintenance and Support Services Organization (MedDRA MSSO). MedDRA Term Selection: Points to Consider Document. October 2011.
Mondal A, Kundu B, Gupta S, et al. Secondary malignant giant cell tumour of bone - - a study of five cases with short review of literature. Indian J Pathol Microbiol. 2002;45(3):273-5.
Reid R, Banerjee SS, Sciot R. Giant cell tumours. Pathology and genetics of tumours of soft tissue and bone - Capter 16. In: Fletcher CDM, Unni K, Mertens F, editors. World Health Organization
Classification of Tumours. 1st ed. Lyon: IARC Press;2002. p. 310-2.
Szendröi M. Giant-cell tumour of bone [Review]. J Bone Joint Surg [Br]. 2004;86-B:5-12.
Szendröi M, Kiss J, Antal I. Surgical treatment and prognostic factors in giant cell tumor of bone. Acta Chir Orthop Traumatol Cech. 2003;70(3):142-50.
Unni KK. Malignancy in giant cell tumor of bone - Capter 20. In: Dahlin’s bone tumors: general aspects and data on 11,087 cases. Philadelphia: Lippincott-Raven; 1996. p. 285-9.
Zheng M, Robbins P, Xu J, et al. The histogenesis of giant cell tumour of bone: a model of interaction between neoplastic cells and osteoclasts. Histol Histopathol. 2001;16:297-307.
日本整形外科学会骨軟部腫瘍委員会, 全国骨腫瘍登録一覧表（平成
20
年度）; 2008.2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
59
付録
2
体系的な有害事象検索に用いたMedDRA
基本語本付録には、複合事象カテゴリーを規定するために用いた有害事象検索用の
MedDRA
基本 語を提示する。集計は治験薬投与後に発現した有害事象について実施した。2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-1
低カルシウム血症の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Blood calcium decreased Muscle contractions involuntary
Calcium deficiency Muscle spasms
Calcium ionised decreased Muscle twitching
Hypocalcaemia Paraesthesia
Arrhythmia Paraesthesia oral
Arrhythmia supraventricular Partial seizures
Blood calcium abnormal Seizure cluster
Calcium ionised abnormal Tachyarrhythmia
Calcium metabolism disorder Tetany
Convulsion Tonic clonic movements
Electrocardiogram QT interval abnormal Tonic convulsion
Electrocardiogram QT prolonged Torsade de pointes
Hypoaesthesia Ventricular arrhythmia
Hypoaesthesia oral Ventricular fibrillation
Page 1 of 1
a Adverse events used in search strategy based on MedDRA Version 14.1
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
61
表
2.7.4.7-2
低カルシウム血症の定義に使用したMedDRA
基本語（試験AMG162-B-J201、3
試験併合解析）MedDRA Preferred Terma
Blood calcium decreased Calcium ionised decreased Hypocalcaemia Trousseau's sign
Calcium deficiency Chvostek's sign Hypocalcaemic seizure
Page 1 of 1
a Adverse events used in search strategy based on MedDRA Version 15.1.
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-3 ONJ
独立判定委員会で判定することとした事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Abscess jaw Necrosis
Abscess oral Oral cavity fistula
Alveolar osteitis Oral surgery
Bone debridement Oroantral fistula
Bone disorder Ostectomy
Bone erosion Osteitis
Bone fistula Osteomyelitis
Bone infarction Osteomyelitis acute
Chronic recurrent multifocal osteomyelitis Osteomyelitis chronic
Dental fistula Osteomyelitis drainage
Dental necrosis Osteonecrosis
Exposed bone in jaw Osteonecrosis of jaw
Gingival abscess Pain in jaw
Gingival erosion Periodontal destruction
Gingival ulceration Periodontal infection
Jaw disorder Periodontal operation
Jaw lesion excision Primary sequestrum
Jaw operation Secondary sequestrum
Loose tooth Sequestrectomy
Maxillofacial operation Tertiary sequestrum
Page 1 of 1
a Adverse events used in search strategy based on MedDRA Version 14.1
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
63
表
2.7.4.7-4 ONJ
独立判定委員会で判定することとした事象の定義に使用したMedDRA
基本語（試験AMG162-B-J201、3
試験併合解析）MedDRA Preferred Terma
Abscess jaw Exposed bone in jaw Oral surgery Periodontal destruction
Abscess oral Gingival abscess Oroantral fistula Periodontal operation
Alveolar osteitis Gingival erosion Ostectomy Primary sequestrum
Bone debridement Gingival ulceration Osteitis Secondary sequestrum
Bone disorder Jaw disorder Osteomyelitis Sequestrectomy
Bone erosion Jaw lesion excision Osteomyelitis acute Tertiary sequestrum
Bone fistula Jaw operation Osteomyelitis chronic Exostosis of jaw
Bone infarction Loose tooth Osteomyelitis drainage Gingival inflammation
Chronic recurrent multifocal
osteomyelitis Maxillofacial operation Osteonecrosis Periodontal inflammation
Dental fistula Necrosis Osteonecrosis of jaw Periodontitis
Dental necrosis Oral cavity fistula Pain in jaw
Page 1 of 1
a Adverse events used in search strategy based on MedDRA Version 15.1.
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-5
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Acute generalised exanthematous pustulosis Anti-neutrophil cytoplasmic antibody positive vasculitis Dermatitis allergic
Administration site rash Antiallergic therapy Dermatitis atopic
Allergic bronchitis Antiendomysial antibody positive Dermatitis bullous
Allergic colitis Application site dermatitis Dermatitis contact
Allergic cough Application site hypersensitivity Dermatitis exfoliative
Allergic cystitis Application site rash Dermatitis exfoliative generalised
Allergic granulomatous angiitis Application site urticaria Dermatitis herpetiformis
Allergic hepatitis Arthritis allergic Dermatitis infected
Allergic keratitis Atopy Dermatitis psoriasiform
Allergic myocarditis Blepharitis allergic Documented hypersensitivity to administered drug
Allergic oedema Blood immunoglobulin E abnormal Drug eruption
Allergic otitis media Blood immunoglobulin E increased Drug hypersensitivity
Allergic pharyngitis Bromoderma Drug rash with eosinophilia and systemic symptoms
Allergic respiratory disease Bronchospasm Eczema
Allergic respiratory symptom Catheter site rash Eczema infantile
Allergic sinusitis Catheter site urticaria Eczema nummular
Allergic transfusion reaction Circumoral oedema Eczema vaccinatum
Allergy test positive Conjunctival oedema Eczema vesicular
Allergy to vaccine Conjunctivitis allergic Eczema weeping
Alveolitis allergic Contact stomatitis Encephalitis allergic
Analgesic asthma syndrome Contrast media allergy Encephalopathy allergic
Anaphylactic reaction Contrast media reaction Epidermal necrosis
Anaphylactic shock Corneal oedema Epidermolysis
Anaphylactic transfusion reaction Cutaneous vasculitis Epidermolysis bullosa
Anaphylactoid reaction Dapsone syndrome Epiglottic oedema
Anaphylactoid shock Dennie-Morgan fold Erythema multiforme
Anaphylaxis treatment Dermatitis Erythema nodosum
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
65
表
2.7.4.7-5
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Eye allergy Interstitial granulomatous dermatitis Photosensitivity allergic reaction
Eye oedema Iodine allergy Pruritus allergic
Eyelid oedema Kaposi's varicelliform eruption Radioallergosorbent test positive
Face oedema Kounis syndrome Rash
First use syndrome Laryngeal oedema Rash erythematous
Fixed eruption Laryngitis allergic Rash follicular
Giant papillary conjunctivitis Laryngospasm Rash generalised
Haemorrhagic urticaria Laryngotracheal oedema Rash macular
Henoch-Schonlein purpura Leukocytoclastic vasculitis Rash maculo-papular
Henoch-Schonlein purpura nephritis Limbal swelling Rash maculovesicular
Heparin-induced thrombocytopenia Lip oedema Rash morbilliform
Hypersensitivity Lip swelling Rash neonatal
Immediate post-injection reaction Mucocutaneous rash Rash papulosquamous
Immune tolerance induction Multiple allergies Rash pruritic
Implant site dermatitis Nephritis allergic Rash pustular
Implant site hypersensitivity Nikolsky's sign Rash rubelliform
Implant site rash Oculomucocutaneous syndrome Rash scarlatiniform
Implant site urticaria Oculorespiratory syndrome Rash vesicular
Infusion site dermatitis Oedema mouth Reaction to azo-dyes
Infusion site hypersensitivity Oral allergy syndrome Reaction to colouring
Infusion site rash Oropharyngeal blistering Reaction to drug excipients
Infusion site urticaria Oropharyngeal spasm Reaction to preservatives
Injection site dermatitis Oropharyngeal swelling Red man syndrome
Injection site hypersensitivity Palatal oedema Rhinitis allergic
Injection site rash Palpable purpura Scleral oedema
Injection site urticaria Periorbital oedema Scleritis allergic
Injection site vasculitis Pharyngeal oedema Scrotal oedema
Page 2 of 5
a Adverse events used in search strategy based on MedDRA Version 14.1
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-5
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Serum sickness Vaccination site dermatitis Blister
Serum sickness-like reaction Vaccination site exfoliation Blood immunoglobulin A abnormal
Skin necrosis Vaccination site hypersensitivity Blood immunoglobulin A increased
Skin reaction Vaccination site rash Blood immunoglobulin D increased
Skin test positive Vaccination site urticaria Blood immunoglobulin G abnormal
Small bowel angioedema Vaccination site vesicles Blood immunoglobulin G increased
Solar urticaria Vaginal exfoliation Blood immunoglobulin M abnormal
Solvent sensitivity Vaginal ulceration Blood immunoglobulin M increased
Stevens-Johnson syndrome Vasculitic rash Bronchial hyperreactivity
Swelling face Vulval ulceration Bronchial oedema
Swollen tongue Vulvovaginal ulceration Bullous impetigo
Tongue oedema Acute respiratory failure Capillaritis
Toxic epidermal necrolysis Allergy to chemicals Charcot-Leyden crystals
Toxic skin eruption Allergy to fermented products Choking
Tracheal oedema Allergy to plants Choking sensation
Type I hypersensitivity Alpha tumour necrosis factor increased Chronic eosinophilic rhinosinusitis
Type II hypersensitivity Alveolitis Chronic hyperplastic eosinophilic sinusitis
Type III immune complex mediated reaction Anti-insulin antibody increased Circulatory collapse
Type IV hypersensitivity reaction Anti-insulin antibody positive Complement factor C1 decreased
Urticaria Anti-insulin receptor antibody increased Complement factor C1 increased
Urticaria cholinergic Anti-insulin receptor antibody positive Complement factor C2 decreased
Urticaria chronic Antibody test abnormal Complement factor C2 increased
Urticaria contact Antibody test positive Complement factor C3 decreased
Urticaria papular Asthma Complement factor C3 increased
Urticaria physical Asthma late onset Complement factor C4 decreased
Urticaria pigmentosa Asthmatic crisis Complement factor C4 increased
Urticaria vesiculosa Auricular swelling Complement factor decreased
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
67
表
2.7.4.7-5
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma
Complement factor increased Gingival swelling Necrotising panniculitis
Complement fixation abnormal Gleich's syndrome Neurodermatitis
Complement fixation test positive Haemolytic transfusion reaction Neutralising antibodies positive
Conjunctivitis Hereditary angioedema Non-neutralising antibodies positive
Corneal exfoliation HLA marker study positive Occupational asthma
Cough Hypotension Oedema mucosal
Dyspnoea Idiopathic urticaria Oedema peripheral
Eosinophil count abnormal Immune complex level increased Oral mucosal exfoliation
Eosinophil count increased Immunoglobulins abnormal Orbital oedema
Eosinophil percentage abnormal Immunoglobulins increased Panniculitis
Eosinophil percentage increased Immunology test abnormal Penile exfoliation
Eosinophilia Infantile asthma Penile oedema
Eosinophilia myalgia syndrome Interstitial lung disease Penile swelling
Eosinophilic bronchitis Laryngeal dyspnoea Perivascular dermatitis
Eosinophilic oesophagitis Laryngeal obstruction Pneumonitis
Eosinophilic pneumonia Leukotriene increased Prurigo
Eosinophilic pneumonia acute Lip exfoliation Pruritus
Eosinophilic pneumonia chronic Localised oedema Pruritus generalised
Erythema Mechanical urticaria Pulmonary eosinophilia
Eye swelling Mesenteric panniculitis Reactive airways dysfunction syndrome
Flushing Mouth ulceration Respiratory arrest
Gastrointestinal oedema Mucocutaneous ulceration Respiratory distress
Generalised erythema Mucosa vesicle Respiratory failure
Generalised oedema Mucosal erosion Respiratory tract oedema
Genital rash Mucosal exfoliation Reversible airways obstruction
Genital swelling Mucosal necrosis Rhinitis perennial
Gingival oedema Mucosal ulceration Rhinitis seasonal
Page 4 of 5
a Adverse events used in search strategy based on MedDRA Version 14.1
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-5
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（外国2
試験併合解析）MedDRA Preferred Terma Scrotal swelling Seasonal allergy Seasonal conjunctivitis Septal panniculitis Shock
Skin erosion Skin exfoliation Skin oedema Skin swelling Sneezing Status asthmaticus Stomatitis
Streptokinase antibody increased Stridor
Suffocation feeling Throat tightness Tongue exfoliation Tracheal obstruction Tracheostomy
Upper airway obstruction Vaginal oedema Visceral oedema Vulval oedema Vulvovaginal swelling Wheezing
Page 5 of 5
a Adverse events used in search strategy based on MedDRA Version 14.1
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
69
表
2.7.4.7-6
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（試験AMG162-B-J201、3
試験併合解析）MedDRA Preferred Terma
Actinic prurigo Analgesic asthma syndrome Bronchospasm Dermatitis contact
Acute generalised exanthematous
pustulosis Anaphylactic reaction Catheter site rash Dermatitis exfoliative
Administration site rash Anaphylactic shock Catheter site urticaria Dermatitis exfoliative generalised Allergic bronchitis Anaphylactic transfusion reaction Chronic actinic dermatitis Dermatitis herpetiformis
Allergic colitis Anaphylactoid reaction Chronic spontaneous urticaria Dermatitis infected
Allergic cough Anaphylactoid shock Circumoral oedema Dermatitis psoriasiform
Allergic cystitis Anaphylaxis treatment Cold urticaria Documented hypersensitivity to
administered drug
Allergic granulomatous angiitis Angioedema Conjunctival oedema Drug eruption
Allergic hepatitis Anti-neutrophil cytoplasmic antibody
positive vasculitis Conjunctivitis allergic Drug hypersensitivity
Allergic keratitis Antiallergic therapy Contact stomatitis Drug rash with eosinophilia and
systemic symptoms
Allergic myocarditis Antiendomysial antibody positive Contrast media allergy Eczema
Allergic oedema Application site dermatitis Contrast media reaction Eczema infantile
Allergic otitis media Application site hypersensitivity Corneal oedema Eczema nummular
Allergic pharyngitis Application site rash Cutaneous vasculitis Eczema vaccinatum
Allergic respiratory disease Application site urticaria Dapsone syndrome Eczema vesicular
Allergic respiratory symptom Arthritis allergic Dennie-Morgan fold Eczema weeping
Allergic sinusitis Atopy Dermatitis Encephalitis allergic
Allergic transfusion reaction Blepharitis allergic Dermatitis acneiform Encephalopathy allergic Allergy test positive Blood immunoglobulin E abnormal Dermatitis allergic Epidermal necrosis
Allergy to vaccine Blood immunoglobulin E increased Dermatitis atopic Epidermolysis
Alveolitis allergic Bromoderma Dermatitis bullous Epidermolysis bullosa
Page 1 of 3
a Adverse events used in search strategy based on MedDRA Version 15.1.
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
表
2.7.4.7-6
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（試験AMG162-B-J201、3
試験併合解析）MedDRA Preferred Terma
Epiglottic oedema Infusion site hypersensitivity Nikolsky's sign Rash neonatal
Erythema multiforme Infusion site rash Oculomucocutaneous syndrome Rash papulosquamous
Erythema nodosum Infusion site urticaria Oculorespiratory syndrome Rash pruritic
Exfoliative rash Injection site dermatitis Oedema mouth Rash pustular
Eye allergy Injection site hypersensitivity Oral allergy syndrome Rash rubelliform
Eye oedema Injection site rash Oropharyngeal blistering Rash scarlatiniform
Eyelid oedema Injection site urticaria Oropharyngeal spasm Rash vesicular
Face oedema Injection site vasculitis Oropharyngeal swelling Reaction to azo-dyes
First use syndrome Interstitial granulomatous dermatitis Palatal oedema Reaction to colouring
Fixed eruption Iodine allergy Palpable purpura Reaction to drug excipients
Giant papillary conjunctivitis Kaposi's varicelliform eruption Periorbital oedema Reaction to preservatives
Haemorrhagic urticaria Kounis syndrome Pharyngeal oedema Red man syndrome
Henoch-Schonlein purpura Laryngeal oedema Photosensitivity reaction Rhinitis allergic
Henoch-Schonlein purpura nephritis Laryngitis allergic Pruritus allergic Rubber sensitivity Heparin-induced thrombocytopenia Laryngospasm Radioallergosorbent test positive Scleral oedema
Hypersensitivity Laryngotracheal oedema Rash Scleritis allergic
Immediate post-injection reaction Leukocytoclastic vasculitis Rash erythematous Scrotal oedema
Immune tolerance induction Limbal swelling Rash follicular Serum sickness
Implant site dermatitis Lip oedema Rash generalised Serum sickness-like reaction
Implant site hypersensitivity Lip swelling Rash macular Skin necrosis
Implant site rash Mucocutaneous rash Rash maculo-papular Skin reaction
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
71
表
2.7.4.7-6
過敏症と関連する可能性がある有害事象の定義に使用したMedDRA
基本語（試験AMG162-B-J201、3
試験併合解析）MedDRA Preferred Terma
Solar urticaria Tracheal oedema Urticaria contact Vaccination site rash
Solvent sensitivity Type I hypersensitivity Urticaria papular Vaccination site urticaria
Stevens-Johnson syndrome Type II hypersensitivity Urticaria physical Vaccination site vesicles
Swelling face Type III immune complex mediated
reaction Urticaria pigmentosa Vaginal exfoliation
Swollen tongue Type IV hypersensitivity reaction Urticaria vesiculosa Vaginal ulceration
Tongue oedema Urticaria Vaccination site dermatitis Vasculitic rash
Toxic epidermal necrolysis Urticaria cholinergic Vaccination site exfoliation Vulval ulceration Toxic skin eruption Urticaria chronic Vaccination site hypersensitivity Vulvovaginal ulceration
Page 3 of 3
a Adverse events used in search strategy based on MedDRA Version 15.1.
2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
付録
3
米国国立がん研究所CTCAE
による臨床検査結果の重症度グレード基準2.7.4
臨床的安全性の概要デノスマブ ランマーク皮下注
120mg
73
表
2.7.4.7-7
米国国立がん研究所の共通毒性規準（第3.0
版）（試験
20040215、試験 20062004、外国 2
試験併合解析）Category Grade
Adverse
Event 0 1 2 3 4
Blood/Bone Marrow
Hemoglobin WNL <LLN - 100 g/L 80 -<100 g/L 65 - <80 g/L <65 g/L
Leukocytes
(total WBC) WNL <LLN - 3.0x109/L ≥2.0 - <3.0x109/L ≥1.0 - <2.0x 109/L <1.0x109/L Lymphopenia WNL <LLN -1.0x109/L ≥0.5 - <1.0x109/L <0.5x 109/L -Platelets WNL <LLN -75.0x109/L ≥50.0- <75.0x109/L ≥10.0 - <50.0x109/L <10.0x109/L Hepatic
Alkaline
phosphatase WNL >ULN - 2.5xULN >2.5 - 5.0xULN >5.0 - 20.0xULN >20.0xULN Bilirubin WNL >ULN -1.5xULN >1.5 - 3.0xULN >3.0 - 10.0xULN >10.0xULN
Hypoalbuminemia WNL <LLN -3 g/dL ≥2 - <3 g/dL <2 g/dL
-Aspartate
aminotransferase WNL >ULN -2.5xULN >2.5 -5.0xULN >5.0 - 20.0xULN >20.0xULN Alanine
aminotransferase WNL >ULN -2.5xULN >2.5 -5.0xULN >5.0 - 20.0xULN >20.0xULN Metabolic/Laboratory
Bicarbonate WNL <LLN - 16 mEq/dL 11 - 15 mEq/dL 8 - 10 mEq/dL <8 mEq/dL
Hypoalbuminemia WNL - 2 - < 3.0 g/dL 1.7 - < 2.2 mmol/L
-Hypocalcemia WNL <LLN - 2.0 mmol/L 1.75 - <2.0 mmol/L 1.5 - <1.75 mmol/L <1.5 mmol/L Hypercalcemia WNL >ULN - 2.9 mmol/L >2.9 - 3.1 mmol/L >3.1 - 3.4 mmol/L >3.4 mmol/L
Hypokalemia WNL <LLN - 3.0 mmol/L - 2.5 - <3.0 mmol/L <2.5 mmol/L
Hyperkalemia WNL >ULN - 5.5 mmol/L >5.5 - 6.0 mmol/L >6.0 - 7.0 mmol/L >7.0 mmol/L Hypoglycemia WNL - 2.2 - < 3.0 mmol/L 1.7 - < 2.2 mmol/L < 1.7 mmol/L Hyperglycemia WNL >ULN - 8.9 mmol/L >8.9 – 13.9 mmol/L >13.9 – 27.8 mmol/L >27.8 mmol/L Hypomagnesemia WNL <LLN -0.5 mmol/L 0.4 - <0.5 mmol/L 0.3 - <0.4 mmol/L <0.3 mmol/L Hypermagnesemia WNL >ULN -1.23 mmol/L - >1.23 - 3.30 mmol/L >3.30 mmol/L
Hyponatremia WNL <LLN - 130 mmol/L - 120 - <130 mmol/L <120 mmol/L
Hypernatremia WNL >ULN - 150 mmol/L >150 - 155 mmol/L >155 - 160 mmol/L >160 mmol/L Hypophosphatemia WNL <LLN -0.8 mmol/L ≥0.6 - <0.8 mmol/L ≥0.3 - <0.6 mmol/L <0.3 mmol/L Renal/Genitourinary
Creatinine WNL >ULN - 1.5xULN >1.5 - 3.0xULN >3.0 - 6.0xULN >6.0xULN Source: National Cancer Institute Common Toxicity Criteria, Version 3.0
Note: WNL = within normal limits, LLN = lower limit of normal, ULN = upper limit of normal.