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Table 6 Drug-related treatment-emergent adverse events ≥1% in either treatment group (SAF)

From: Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR)

TEAEs, n (%)

Placebo (n = 442)

Mirabegron Total (n = 445)

Drug-related TEAEsa

57 (12.9)

84 (18.9)

 Dry mouth

7 (1.6)

6 (1.3)

 Nausea

3 (0.7)

6 (1.3)

 Constipation

4 (0.9)

3 (0.7)

 Diarrhea

1 (0.2)

5 (1.1)

 Headache

7 (1.6)

18 (4.0)

 Dizziness

6 (1.4)

2 (0.4)

 Somnolence

1 (0.2)

2 (0.4)

 Escherichia urinary tract infection

7 (1.6)

9 (2.0)

 Fatigue

10 (2.3)

7 (1.6)

  1. aPossible or probable, as assessed by the investigator, or where relationship was missing
  2. SAF safety analysis set, TEAEs treatment-emergent adverse events