sp; Hyponatremia 11 ( 10) 14 ( 13)
Hypercalcemia 22 ( 21) 13 (12)
Hypocalcemia 6 (6) 13 ( 12)
Hypokalemia 11 ( 10) 12 ( 11)
Skin and subcutaneous tissue disorders
Hyperhidrosis 6 ( 6) 18 ( 16)
Rash 23 ( 22) 18 ( 16)
Night sweats 5 ( 5) 14 ( 13)
Dry skin 10 ( 9) 12 ( 11)
Pruritus 16 ( 15) 12 ( 11)
Nervous system disorders
Dizziness 21 ( 20) 19 ( 17)
Tremor 10 ( 9) 14 ( 13)
Headache 14 ( 13) 9 ( 8)
Neuropathy peripheral 11 ( 10) 8 ( 7)
Investigations
Blood creatinine increased 16 ( 15) 12 ( 11)
Weight increased 1 ( 1) 12 ( 11)
Weight decreased 15 ( 14) 9 ( 8)
Psychiatric disorders
Insomnia 7 ( 7) 16 ( 14)
Confusional state 11 ( 10) 15 ( 13)
Anxiety 12 ( 11) 8 ( 7)
Renal and urinary disorders
Renal failure 16 ( 15) 11 ( 10)
Table 3: Grade 3/4 Adverse Reactions Reported in ≥ 5% of Patients in Any Treatment Arm a Pomalyst alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.
Trial 1
Pomalysta
(N = 107) Pomalyst +
Low dose Dex
(N=112)
System Organ Class/Preferred Term [a] n (%) n (%)
Number(%) of Patients With at Least One Treatment
Emergent NCI CTC Grade 3 or 4 Adverse Reaction 96 ( 90) 99 ( 88)
Blood and lymphatic system disorders
Neutropenia 50 ( 47) 43 ( 38)
Anemia 24 ( 22) 23 ( 21)
Thrombocytopenia 24 ( 22) 21 ( 19)
Leukopenia 6 ( 6) 11 ( 10)
Lymphopenia 2 ( 2) 8 ( 7)
Infections and infestations
Pneumonia 17 ( 16) 26 (23)
Urinary tract infection 2 ( 2) 9 ( 8)
Sepsis 6 ( 6) 3 ( 3)
Metabolism and nutritional disorders
Hypercalcemia 10 ( 9) 1 ( 1)
General disorders and administration site conditions
Fatigue and asthenia 12 ( 11) 14 ( 13)
Investigations
Blood creatinine increased 6 ( 6) 3 ( 3)
Respiratory, thoracic and mediastinal disorders
Dyspnea 7 ( 7) 14 ( 13)
Musculoskeletal and connective tissue disorders
Back pain 13 ( 12) 10 ( 9)
Muscular weakness 6 ( 6) 4 ( 4)
Renal and urinary disorders
Renal failure 10 ( 9) 7 ( 6)
Table 4: S |
