Table A1.
Disorder | Dose (mg/kg) |
Total No. of Patients (N = 39) |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
0.3 (n = 6) |
1.0 (n = 6) |
3 (n = 6) |
10 (n = 21) |
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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.