Table 4.

Adverse eventsa (serious adverse events, overall, and most common) in placebo (n = 102) and nortriptyline (n = 99) groupsb

EventPlacebo, n (%)Nortriptyline, n (%)P-value
Serious adverse events
Overall3 (2.9)4 (4.0)0.72
  Life-threatening myocardial infarctionc0 (0.0)1 (1.0)
  Hospitalisation for lower back pain1 (1.0)0 (0.0)
  Hospitalisation for atrial fibrillationc0 (0.0)1 (1.0)
  Hospitalisation for epistaxis0 (0.0)1 (1.0)
  Hospitalisation for renal calculi1 (1.0)0 (0.0)
  Hospitalisation for lung infection1 (1.0)0 (0.0)
  Hospitalisation for hyperglycaemia0 (0.0)1 (1.0)
Adverse events (Antidepressant Side-Effect Checklist at week 14)
  Any adverse events88 (86.3)97 (98.0)0.001
Largest differences
  Dry mouth52 (51.0)86 (86.9)<0.001
  Constipation31 (30.4)58 (58.6)<0.001
  Sweating21 (20.6)31 (31.3)0.033
  Sexual dysfunction9 (8.8)17 (17.2)0.084
  Headache27 (26.5)14 (14.1)0.009
  Diarrhoea21 (20.6)11 (11.1)0.060
  • a Each event is only recorded once per patient.

  • b Antidepressant Side-Effect Checklist data relates to those assessed for knee pain at week 14 only.

  • c Considered to be related to the study medication.