Table 4.

Study drug-related^a serious adverse events by preferred term

Preferred termb	Study	Intensity	Outcome	Discontinued study due to this adverse event
Exenatide BID
Hypertension	Heine et al5	Moderate	Recovered	No
Vomiting	Heine et al5	Severe	Recovered	No
Injection-site cellulitis	Nauck et al9	Severe	Unknown	Yes
Nausea	Nauck et al9	Severe	Unknown	Yes
Anorexia	Nauck et al9	Severe	Unknown	No
Weight loss	Nauck et al9	Severe	Unknown	No
Hyperglycemia	Davis et al8	Severe	Recovered	Yes
Allergic alveolitis	Zinman et al6	Severe	Recovered	No
Gastroesophageal reflux disease	DeFronzo et al14	Severe	Not resolved	No
Gastroenteritis	DeFronzo et al14	Severe	Recovered	No
Hemorrhoidal hemorrhage	DeFronzo et al14	Severe	Recovered	No
Allergic dermatitis	Gallwitz et al19	Severe	Not resolved	Yes
Accidental overdose	Buse et al20,66	Mild	Recovered	No
Gastritis	DeFronzo et al3	Severe	Recovered	Yes
Presyncope	Kendall et al4	Severe	Recovered	No
Acute pancreatitis	Kadowaki et al17	Moderate	Recovered	Yes
Hypoglycemia	Gao et al10	Severe	Recovered	No
Acute myocardial infarction	Davies et al13	Severe	Recovered	No
Supraventricular tachycardia	Davies et al13	Severe	Recovered	No
Insulin glargine
Ureteric calculus	Heine et al5	Severe	Recovered	No
Angiodema	Heine et al5	Severe	Recovered	No

Notes:

^aDetermined by the investigator to be possibly, probably, or definitely related to study drug;

^bevents listed by preferred term (MedDRA v 13.0 terms) are the individual events observed.

Abbreviation: BID, twice daily.