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Table 5 Adverse events reported during the 6-week treatment with WS® 5570 or placebo (safety analysis set)

From: Superior efficacy of St John's wort extract WS®5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298]

Type of adverse event (MedDRA System Organ Class) Number (%) of patients with adverse events* p-value
  WS® 5570 600 mg/day N = 123 WS® 5570 1200 mg/day N = 127 Placebo N = 82 WS® 5570 600 mg/day vs placebo WS® 5570 1200 mg/day vs placebo
All adverse events 49 (39.8) 50 (39.4) 22 (26.8) 0.07 0.07
Ear and labyrinth disorders 3 (2.4) 2 (1.6) 1 (1.2) 0.65 1.00
Eye disorders 0 (0.0) 1 (0.8) 0 (0.0) 1.00 1.00
Gastrointestinal disorders 24 (19.5) 30 (23.6) 13 (15.9) 0.58 0.22
General disorders and administration site conditions 2 (1.6) 2 (1.6) 0 (0.0) 0.52 0.52
Infections and infestations 7 (5.7) 4 (3.2) 2 (2.4) 0.32 1.00
Injury, poisoning and procedural complications 1 (0.8) 1 (0.8) 1 (1.2) 1.00 1.00
Investigations 1 (0.8) 0 (0.0) 0 (0.0) 1.00 1.00
Metabolism and nutrition disorders 1 (0.8) 1 (0.8) 1 (1.2) 1.00 1.00
Musculosceletal and connective tissue disorder 1 (0.8) 2 (1.6) 1 (1.2) 1.00 1.00
Nervous system disorder 6 (4.9) 6 (4.7) 2 (2.4) 0.48 0.49
Psychiatric disorders 2 (1.6) 2 (1.6) 0 (0.0) 0.52 0.52
Renal and unrinary disorders 1 (0.8) 0 (0.0) 0 (0.0) 1.00 1.00
Reproductive system and breast disorders 1 (0.8) 2 (1.6) 0 (0.0) 1.00 0.52
Respiratory, thoracic and mediastinal disorders 4 (3.3) 5 (3.9) 2 (2.4) 1.00 0.71
Skin and subcutaneous disorders 4 (3.3) 2 (1.6) 4 (4.9) 0.72 0.21
Vascular disorders 1 (0.8) 1 (0.8) 0 (0.0) 1.00 1.00
  1. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 5.1.
  2. *Patients may have experienced more than one adverse event.