Table 4 Summary of serious adverse events, adverse drug reactions, and AEs leading to discontinuation (safety analysis set)
Occurring in ≥0.2% of patients, No. (%) | Dapagliflozin (N = 2990) |
|---|---|
 ≥ 1 SAE | 186 (6.2) |
 Metabolism and nutrition disorders | 34 (1.1) |
  Inadequate control of T2DMa | 20 (0.7) |
  Diabetic ketosis | 8 (0.3) |
  Hyperglycaemia | 5 (0.2) |
 Infections and infestations | 26 (0.9) |
  Pneumonia | 8 (0.3) |
 Nervous system disorders | 23 (0.8) |
  Cerebral infarction | 6 (0.2) |
 Cardiac disorders | 21 (0.7) |
  Coronary artery disease | 7 (0.2) |
 Gastrointestinal disorders | 15 (0.5) |
  Large intestine polyp | 5 (0.2) |
 Eye disorders | 14 (0.5) |
 Musculoskeletal and connective tissue disorders | 12 (0.4) |
  Intervertebral disc protrusion | 5 (0.2) |
 Injury, poisoning and procedural complications | 9 (0.3) |
 Neoplasms | 8 (0.3) |
 Renal and urinary disorders | 7 (0.2) |
 Vascular disorders | 7 (0.2) |
  Hypertension | 5 (0.2) |
 General disorders and administration site conditions | 6 (0.2) |
 Hepatobiliary disorders | 5 (0.2) |
 Reproductive system and breast disorders | 5 (0.2) |
≥1 ADR | 268 (9.0) |
 Renal and urinary disorders | 74 (2.5) |
  Urinary tract infection | 49 (1.6) |
 Metabolism and nutrition disorders | 56 (1.9) |
  Hypoglycaemia | 19 (0.6) |
  Diabetic ketosis | 15 (0.5) |
 Reproductive system and breast disorders | 45 (1.5) |
  Vulvovaginal pruritus | 13 (0.4) |
  Vaginal infection | 10 (0.3) |
 Gastrointestinal disorders | 41 (1.4) |
  Dry mouth | 11 (0.4) |
 Investigations | 35 (1.2) |
  Weight decreased | 17 (0.6) |
 General disorders and administration site conditions | 21 (0.7) |
  Asthenia | 9 (0.3) |
  Thirst | 5 (0.2) |
 Skin and subcutaneous tissue disorders | 10 (0.3) |
 Musculoskeletal and connective tissue disorders | 8 (0.3) |
 Nervous system disorders | 7 (0.2) |
 Vascular disorders | 5 (0.2) |
AE leading to discontinuation | |
 Renal and urinary disorders | 29 (1.0) |
  Urinary tract infection | 14 (0.5) |
 Gastrointestinal disorders | 25 (0.8) |
  Dry mouth | 5 (0.2) |
 Reproductive system and breast disorders | 25 (0.8) |
  Vaginal infection | 7 (0.2) |
  Vulvovaginal pruritus | 6 (0.2) |
 Metabolism and nutrition disorders | 19 (0.6) |
  Diabetic ketosis | 7 (0.2) |
  Inadequate control of T2DM | 6 (0.2) |
 Investigations | 16 (0.5) |
  Weight decreased | 9 (0.3) |
 General disorders and administration site conditions | 10 (0.3) |
  Asthenia | 5 (0.2) |
 Skin and subcutaneous tissue disorders | 10 (0.3) |
  Pruritis | 5 (0.2) |
 Musculoskeletal and connective tissue disorders | 7 (0.2) |