Table 3.

Symptoms and adverse events

EmpagliflozinPlacebo
BaselineDay 4Day 30BaselineDay 4Day 30
Symptoms
 General wellbeing, VAS5 (3–7)6 (5–8)7 (6–8)5 (5–6)7 (5–8)6 (5–8)
 Thirst, n (%)20 (47)18 (42)10 (23)18 (41)17 (39)9 (21)
 Vertigo, n (%)11 (26)7 (16)8 (19)16 (36)10 (23)19 (43)
 Headache, n (%)14 (33)9 (21)9 (21)11 (25)9 (21)8 (18)
 Nausea, n (%)9 (21)4 (9)2 (5)12 (27)5 (11)7 (16)
AEs
 All causes1410
  Serious AEs55
  Withdrawal because of AE00
 Potentially study related63
  Serious AEs10
  Withdrawal because of AE00
Specific AEs
 Plasma-sodium overcorrection21
  Potentially study related21
  Neurologic complications00
 Decreased renal function30
  Potentially study related3
  Persistent impairment0
 Increased hepatic parameters01
  Potentially study related0
 Urinary tract infection31
  Potentially study related00
 Gastrointestinal disorders10
  Potentially study related0
 Orthostatic collapse02
  Potentially study related2
Specific severe AEs
 Decreased renal function leading to unblinding10
  Potentially study related1
  Persistent impairment0
 Prolongation hospitalization14
  Potentially study related00
 Rehospitalization21
  Potentially study related00
 Death10
  Potentially study related0
  • Course of symptoms and adverse events (AEs) occurring during observation phase. VAS, visual analog scale; n, number of patients.