Safety, tolerability, and effectiveness of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin in combination with standard chemotherapy for patients with advanced, inoperable pancreatic adenocarcinoma: a phase 1b observational study

Table 2 Adverse event profiles by CTCAE v5.0 of all 15 enrolled patients during the trial

	Related to dapagliflozin only		Related to GnP		Related to both dapagliflozin and GnP		Related to all
	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades
Constitutional
Anorexia	0	0	0	4 (27%)	0	1 (7%)	0	5 (33%)
Headache	0	0	0	1 (7%)	0	0	0	1 (7%)
Fatigue	0	1 (7%)	0	3 (20%)	0	2 (13%)	0	6 (40%)
Nausea	0	1 (7%)	0	1 (7%)	0	4 (27%)	0	6 (40%)
Vomiting	0	0	0	0	0	3 (20%)	0	3 (20%)
Hematologic
Leukopenia	0	0	1 (7%)	7 (47%)	1 (7%)	3 (20%)	2 (13%)	10 (67%)
Neutropenia	0	0	1 (7%)	5 (33%)	1 (7%)	2 (13%)	2 (13%)	7 (47%)
Lymphopenia	0	0	1 (7%)	5 (33%)	0	2 (13%)	1 (7%)	7 (47%)
Anemia	0	0	0	9 (60%)	0	6 (40%)	0	15 (100%)
Thrombocytopenia	0	0	0	7 (47%)	0	5 (33%)	0	12 (80%)
Neutropenic fever	0	0	0	0	1 (7%)	1 (7%)	1 (7%)	1 (7%)
Gastro-intestinal tract
Dry mouth	0	1 (7%)	0	0	0	1 (7%)	0	2 (13%)
Constipation	0	0	0	1 (7%)	0	0	0	1 (7%)
Diarrhea	0	0	1 (7%)	4 (27%)	1 (7%)	2 (13%)	2 (13%)	6 (40%)
Colitis	0	0	0	1 (7%)	0	0	0	1 (7%)
Liver
Hypoalbuminemia	0	0	0	0	0	2 (13%)	0	2 (13%)
Increased ALT	0	0	0	4 (27%)	0	5 (33%)	0	9 (60%)
Increased AST	0	0	0	2 (13%)	0	5 (33%)	0	7 (47%)
Increased ALP	0	0	0	2 (13%)	0	4 (27%)	0	6 (40%)
Kidney and electrolytes
Hyponatremia	0	1 (7%)	0	2 (13%)	0	0	0	3 (20%)
Proteinuria	0	0	0	0	0	2 (13%)	0	2 (13%)
Elevated creatinine	0	0	0	0	0	2 (13%)	0	2 (13%)
Dermatologic
Alopecia	0	0	0	10 (67%)	0	0	0	10 (67%)
Rash	0	1 (7%)	0	1 (7%)	0	1 (7%)	0	3 (20%)
Nervous system
Peripheral sensory neuropathy	0	0	0	4 (27%)	0	0	0	4 (27%)
Dysgeusia	0	0	0	1 (7%)	0	0	0	1 (7%)

ISSN: 2049-3002