Table 3

Summary of treatment-emergent AEs in >5% of total patients*

Preferred termPlacebo (n = 30)IONIS-PTP-1BRx (n = 62)
Urinary tract infection9 (30.0)13 (21.0)
Influenza6 (20.0)11 (17.7)
Headache4 (13.3)7 (11.3)
Upper respiratory tract infection2 (6.7)7 (11.3)
Nasopharyngitis3 (10.0)6 (9.7)
Sinusitis1 (3.3)5 (8.1)
Back pain4 (13.3)5 (8.1)
Hypoglycemia1 (3.3)5 (8.1)
 Severe0 (0.0)0 (0.0)
Gastritis1 (3.3)4 (6.5)
Musculoskeletal pain4 (13.3)1 (1.6)
Myalgia2 (6.7)3 (4.8)
Other AEs of interest
 LCRIS1 (3.3)20 (32.3)
  Percentage of injections leading to LCRIS, mean (SD)0.13 (0.73)10.0 (23.1)
 Hyperglycemia1 (3.3)2 (3.2)
  Severe§0 (0.0)0 (0.0)
  • Data are n (%) unless otherwise noted.

  • *Excludes injection site reactions.

  • †Defined as requiring assistance of another person to obtain treatment for the event and has plasma glucose levels <60 mg/dL.

  • ‡Defined as injection site erythema, swelling, pruritus, pain, or tenderness that started on the day of injection and persisted for at least 2 days.

  • §Defined as fasting plasma glucose levels >270 mg/dL on two consecutive study visits.