Table 1.

AE and laboratory abnormalities reported in ≥20% of subjects

PLD + motolimod (N = 13)Paclitaxel + motolimod (N = 7)
All gradesGrade III/IVAll gradesGrade III/IV
AEn (%)n (%)n (%)n (%)
Abdominal pain7 (54)2 (15)3 (49)0 (0)
Alopecia3 (23)0 (0)2 (29)0 (0)
Anemia10 (77)2 (15)7 (100)0 (0)
Anorexia6 (46)0 (0)1 (14)0 (0)
Anxiety3 (23)0 (0)1 (14)0 (0)
Arthralgia6 (46)0 (0)3 (43)0 (0)
Back pain5 (39)0 (0)0 (0)0 (0)
Chills9 (69)1 (8)3 (49)0 (0)
Constipation7 (54)0 (0)2 (29)0 (0)
Cough3 (23)1 (8)2 (29)0 (0)
Diarrhea5 (39)0 (0)4 (57)1 (14)
Dyspnea4 (31)1 (8)3 (43)0 (0)
Fatigue13 (100)0 (0)7 (100)1 (14)
Fever11 (85)1 (8)3 (43)0 (0)
Headache9 (69)0 (0)1 (14)0 (0)
Hypertension4 (31)1 (8)1 (14)1 (14)
Injection site reaction12 (92)0 (0)5 (71)0 (0)
Mucositis oral7 (54)2 (15)0 (0)0 (0)
Myalgia2 (15)0 (0)2 (29)0 (0)
Nausea10 (77)1 (8)4 (57)0 (0)
Palmar–plantar erythrodysesthesia syndrome4 (31)1 (8)0 (0)0 (0)
Paresthesia4 (31)0 (0)0 (0.0)0 (0)
Peripheral sensory neuropathy6 (46)0 (0)4 (57)0 (0)
Vomiting10 (77)2 (15)5 (71)0 (0)
Weight loss2 (15)0 (0)2 (29)0 (0)
Laboratory abnormality
 Hypoalbuminemia3 (23)2 (15)2 (29)0 (0)
 Hypokalemia2 (15)1 (8)2 (29)0 (0)
 Hyponatremia2 (15)1 (8)2 (29)1 (14)
 Platelet count decreased4 (31)1 (8)0 (0)0 (0)
 Neutrophil count decreased8 (62)3 (23)1 (14)1 (14)
 White blood cell decreased8 (62)1 (8)1 (14)1 (14)
  • NOTE: AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE).