Table 3.

Grade 3–4 adverse events experienced by greater than 1% of participants in either the ganitumab + metformin or control arm.

Adverse event	Ganitumab n = 106	Control N = 128
Neutrophil count decreased	20 (18.9%)	13 (10.2%)
Febrile neutropenia	14 (13.2%)	9 (7.0%)
Hyperglycemia	9 (8.5%)	1 (0.8%)
Anemia	8 (7.5%)	8 (6.3%)
Vomiting	7 (6.6%)	0 (0.0%)
Hypertension	4 (3.8%)	4 (3.1%)
Alanine aminotransferase increased	4 (3.8%)	3 (2.3%)
Diarrhea	4 (3.8%)	3 (2.3%)
Bone pain	3 (2.8%)	3 (2.3%)
Lymphocyte count decreased	3 (2.8%)	3 (2.3%)
Syncope	3 (2.8%)	2 (1.6%)
Urinary tract infection	3 (2.8%)	0 (0.0%)
Stomatitis	2 (1.9%)	3 (2.3%)
Neutropenia	2 (1.9%)	2 (1.6%)
Back pain	2 (1.9%)	1 (0.8%)
Dehydration	2 (1.9%)	1 (0.8%)
Pneumonitis	2 (1.9%)	1 (0.8%)
Sepsis	2 (1.9%)	1 (0.8%)
Anaphylactic reaction	2 (1.9%)	0 (0.0%)
Dyspnea	2 (1.9%)	0 (0.0%)
Nausea	2 (1.9%)	0 (0.0%)
Pulmonary embolism	2 (1.9%)	0 (0.0%)
Hypokalemia	1 (0.9%)	4 (3.1%)
Hyponatremia	1 (0.9%)	2 (1.6%)
Premature menopause	1 (0.9%)	2 (1.6%)
Peripheral sensory neuropathy	0 (0.0%)	2 (1.6%)
Dose reductions, n (%)	10 (9.4%)	11 (8.9%)
Early discontinuation, n (%)
All reasons	32 (30.2%)	31 (24.2%)
Toxicity	29 (18.9%)	9 (7.0%)
Progression	8 (7.5%)	10 (7.8%)
Other	4 (3.8%)	12 (9.4%)
Median time to surgery, days (range)	168 (64–313)	165 (100–289)