Table 3.

Serious adverse events by preferred term in ≥1% of patients–safety population.

Preferred term	Abemaciclib N = 265	Erlotinib N = 175
Patients with ≥1 serious adverse event, n (%)	112 (42.3)	43 (24.6)
Lung infection	18 (6.8)	7 (4.0)
Acute kidney injury	11 (4.2)	1 (0.6)
Dehydration	10 (3.8)	1 (0.6)
Diarrhea	10 (3.8)	1 (0.6)
Dyspnea	8 (3.0)	7 (4.0)
Nausea	7 (2.6)	0
Sepsis	6 (2.3)	3 (1.7)
Embolism a	5 (1.9)	2 (1.1)
Respiratory failure	5 (1.9)	1 (0.6)
Vomiting	5 (1.9)	2 (1.1)
Pneumonitis	4 (1.5)	5 (2.9)
Anaemia	3 (1.1)	3 (1.7)
Confusional state	3 (1.1)	0
Decreased appetite	3 (1.1)	1 (0.6)
Fatigue	3 (1.1)	1 (0.6)
General physical health deterioration	3 (1.1)	1 (0.6)
Hyponatraemia	3 (1.1)	1 (0.6)
Pleural effusion	3 (1.1)	2 (1.1)
Thrombocytopenia	3 (1.1)	0
Hyperglycaemia	1 (0.4)	2 (1.1)
Pneumothorax	1 (0.4)	2 (1.1)
Back pain	0	2 (1.1)

DVT, deep vein thrombosis; N, number of patients in the enrolled population; n, number of patients with a serious adverse event.

^aPulmonary embolism (4 patients [1.5%] in abemaciclib arm; 2 patients [1.1%] in erlotinib arm); DVT (1 patient [0.4%] in abemaciclib arm).