thasone (Low dose Dex) (112 patients) or Pomalyst alone (107 patients). Median number of treatment cycles was 5. Sixty three percent of patients in the study had a dose interruption of either drug due to adverse reactions. Thirty seven percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to treatment-related adverse reaction was 3%.
Tables 2, 3 and 4 summarize all treatment-emergent adverse reactions reported for Pomalyst + Low dose Dex and Pomalyst alone groups regardless of attribution of relatedness to pomalidomide. In the absence of a randomized comparator arm, it is often not possible to distinguish adverse events that are drug-related and those that reflect the patient’s underlying disease.
Table 2: Adverse Reactions Reported in 10% of Patients in Any Treatment Arm aPomalyst 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 n (%) n (%)
Number(%) of Patients With at Least One Treatment
Emergent Adverse Reaction 107 (100) 112 (100)
General disorders and administration site
conditions
Fatigue and asthenia 59 (55) 70 (63)
Pyrexia 20 (19) 34 (30)
Edema peripheral 25 (23) 18 (16)
Chills 10 (9) 12 (11)
Pain 6 (6) 5 (5)
Blood and lymphatic system disorders
Neutropenia 56 (52) 53 (47)
Anemia 41 (38) 44 (39)
Thrombocytopenia 27 (25) 26 (23)
Leukopenia 12 (11) 20 (18)
Lymphopenia 4 (4) 17 (15)
Gastrointestinal disorders
Constipation 38 (36) 39 (35)
Diarrhea 36 (34) 37 (33)
Nausea 38 (36) 25 (22)
Vomiting 15 (14) 15 (13)
Infections and infestations
Pneumonia 25 (23) 32 (29)
Upper respiratory tract infection 34 (32) 28 (25)
Urinary tract infection 8 (8) 18 (16)
Musculoskeletal and connective tissue disorders
Back pain 34 (32) 34 (30)
Musculoskeletal chest pain 23 (22) 22 (20)
Muscle spasms 20 (19) 21 (19)
Arthralgia 17 (16) 17 (15)
Musculoskeletal pain 12 (11) 17 (15)
Pain in extremity 5 (5) 16 (14)
Muscular weakness 13 (12) 13 (12)
Bone pain 13 (12) 5 (5)
Respiratory, thoracic and mediastinal disorders
Dyspnea 36 (34) 50 (45)
Cough 15 (14) 23 (21)
Epistaxis 16 (15) 12 (11)
Metabolism and nutritional disorders
Decreased appetite 23 (22) 20 ( 18)
Hyperglycemia 13 ( 12) 17 ( 15)
&nb |
