Table 1. Adverse Events and Laboratory Abnormalities Reported in ≥ 20% of Subjects.
PLD + motolimod n = 13 | paclitaxel + motolimod n = 7 | |||
---|---|---|---|---|
| ||||
Adverse Event | All Grades n (%) | Grade 3/4 n (%) | All Grades n (%) | Grade 3/4 n (%) |
Abdominal pain | 7 (54) | 2 (15) | 3 (49) | 0 (0) |
Alopecia | 3 (23) | 0 (0) | 2 (29) | 0 (0) |
Anemia | 10 (77) | 2 (15) | 7 (100) | 0 (0) |
Anorexia | 6 (46) | 0 (0) | 1 (14) | 0 (0) |
Anxiety | 3 (23) | 0 (0) | 1 (14) | 0 (0) |
Arthralgia | 6 (46) | 0 (0) | 3 (43) | 0 (0) |
Back pain | 5 (39) | 0 (0) | 0 (0) | 0 (0) |
Chills | 9 (69) | 1 (8) | 3 (49) | 0 (0) |
Constipation | 7 (54) | 0 (0) | 2 (29) | 0 (0) |
Cough | 3 (23) | 1 (8) | 2 (29) | 0 (0) |
Diarrhea | 5 (39) | 0 (0) | 4 (57) | 1 (14) |
Dyspnea | 4 (31) | 1 (8) | 3 (43) | 0 (0) |
Fatigue | 13 (100) | 0 (0) | 7 (100) | 1 (14) |
Fever | 11 (85) | 1 (8) | 3 (43) | 0 (0) |
Headache | 9 (69) | 0 (0) | 1 (14) | 0 (0) |
Hypertension | 4 (31) | 1 (8) | 1 (14) | 1 (14) |
Injection site reaction | 12 (92) | 0 (0) | 5 (71) | 0 (0) |
Mucositis oral | 7 (54) | 2 (15) | 0 (0) | 0 (0) |
Myalgia | 2 (15) | 0 (0) | 2 (29) | 0 (0) |
Nausea | 10 (77) | 1 (8) | 4 (57) | 0 (0) |
Palmar-plantar erythrodysesthesia syndrome | 4 (31) | 1 (8) | 0 (0) | 0 (0) |
Paresthesia | 4 (31) | 0 (0) | 0 (0.0) | 0 (0) |
Peripheral sensory neuropathy | 6 (46) | 0 (0) | 4 (57) | 0 (0) |
Vomiting | 10 (77) | 2 (15) | 5 (71) | 0 (0) |
Weight loss | 2 (15) | 0 (0) | 2 (29) | 0 (0) |
Laboratory Abnormality | ||||
Hypoalbuminemia | 3 (23) | 2 (15) | 2 (29) | 0 (0) |
Hypokalemia | 2 (15) | 1 (8) | 2 (29) | 0 (0) |
Hyponatremia | 2 (15) | 1 (8) | 2 (29) | 1 (14) |
Platelet count decreased | 4 (31) | 1 (8) | 0 (0) | 0 (0) |
Neutrophil count decreased | 8 (62) | 3 (23) | 1 (14) | 1 (14) |
White blood cell decreased | 8 (62) | 1 (8) | 1 (14) | 1 (14) |
Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE).