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. 2010 Jun 1;28(19):3167–3175. doi: 10.1200/JCO.2009.26.7609

Table A1.

Grade ≥ 2 Toxicities Attributed to MDX-1106

Disorder Dose (mg/kg)
Total No. of Patients (N = 39)
0.3 (n = 6)
1.0 (n = 6)
3 (n = 6)
10 (n = 21)
No. % No. % No. % No. % No. %
Blood
    Anemia
        Grade 2 0 1 16.7 0 1 4.8 2 5.1
        Grade 3 1 16.7 0 0 0 1 2.6
    CD4 decrease
        Grade 2 0 2 33.3 1 16.7 4 19.0 7 17.9
        Grade 3 1 16.7 0 0 6 28.6 7 17.9
    Lymphopenia
        Grade 2 2 33.3 0 2 33.3 5 23.8 9 23.1
        Grade 3 0 0 0 1 4.8 1 2.6
    Neutropenia
        Grade 2 1 16.7 0 0 0 1 2.6
Cardiovascular
    Hypertension
        Grade 2 1 16.7 0 0 0 1 2.6
Endocrine and metabolic
    Hypocalcemia
        Grade 3 0 0 0 1 4.8 1 2.6
    Hyperglycemia
        Grade 2 0 0 0 1 4.8 1 2.6
    Hypothyroidism
        Grade 2 0 0 0 1 4.8 1 2.6
Gastrointestinal
    Ascites
        Grade 3 1 16.7 0 0 0 1 2.6
    Colitis
        Grade 3 0 1 16.7 0 0 1 2.6
    Stomatitis
        Grade 2 0 0 0 1 4.8 1 2.6
General
    Fatigue
        Grade 2 0 0 3 50.0 2 9.5 5 12.8
        Grade 3 0 0 0 1 4.8 1 2.6
    Infusion site reaction
        Grade 2 0 0 0 2 9.5 2 5.1
    Pyrexia
        Grade 2 0 1 16.7 0 0 1 2.6
Hepatobiliary
    Liver disorder
        Grade 2 1 16.7 0 0 0 1 2.6
Hypersensitivity
        Grade 2 0 0 1 16.7 0 1 2.6
Infections
    Sinusitis/nasal polyps
        Grade 2 0 0 0 1 4.8 1 2.6
    Musculoskeletal*
        Grade 2 0 0 1 16.7 3 14.3 4 10.3
        Grade 3 1 16.7 0 0 1 4.8 2 5.1
Neurologic
    Headache
        Grade 2 0 0 0 1 4.8 1 2.6
Respiratory
    Dyspnea
        Grade 2 0 0 1 16.7 0 1 2.6
    Pleural effusion
        Grade2 1 16.7 0 0 0 1 2.6
    Skin
        Grade 2 0 1 16.7 0 1 4.8 2 5.1
Urinary tract
    Proteinuria
        Grade 2 0 1 16.7 0 0 1 2.6

Abbreviation: MDX-1106, anti–programmed death-1 monoclonal antibody.

*

Musculoskeletal disorders include arthralgia, arthritis, myalgia, extremity pain, joint stiffness, back pain, bone pain, muscular weakness, and polymyalgia rheumatica.

Skin disorders include rash, erythema, pruritis, dry skin, alopecia, hyperhidrosis, lichenoid keratosis, and skin discoloration.