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International Journal of Phytomedicine and Phytotherapy

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Table 4 Incidence of Adverse Events /AE) in individual studies– by system organ class (MedDRA)

From: Black cohosh (Cimicifuga racemosa) is a non-estrogenic alternative to hormone replacement therapy

System organ class Reported incidence by treatment groups
(KLI-DF-1 2001) (BI 563.2)
Klimadynon 40 mg CR BNO 1055 150 mg CR BNO 1055 300 mg CE 0.625 mg Placebo Menofem /Klimadynon 40 mg Placebo
N = 30 N = 33 N = 31 N = 34 N = 33 N = 152 N = 159
  N (%) N (%) N (%) N (%) N (%) N (%) N (%)
Patients with AE 12 (40.0) 12 (36.4) 13 (41.9) 13 (38.2) 12 (36.4) 16 (10.5) 17 (10.7)
Blood and lymphatic disorders        1 (0.6)
Cardiac disorders        
Ear and labyrinth disorders 1 (3.3)     1 (3.0)   
Eye disorders   1 (3.0)      
Gastrointestinal disorders   2 (6.1)   4 (11.8)   2 (1.3) 2 (1.3)
General disorders and administration site conditions       1 (0.7) 1 (0.6)
Immune system disorders        2 (1.3)
Infections and infestations 2 (6.7) 3 (9.1) 1 (3.2) 6 (17.6)   5 (3.3) 4 (2.5)
Injury poisoning and procedural complications 2 (6.7)      1 (0.7)  
Investigations   4 (12.1) 3 (9.7) 1 (2.9)   1 (0.7) 2 (1.3)
Metabolism and nutrition disorders 1 (3.3) 2 (6.1)    1 (3.0) 4 (2.6) 5 (3.1)
Musculoskeletal and connective tissue disorders   1 (3.0) 1 (3.2)   2 (6.1) 1 (0.7) 2 (1.3)
Nervous system disorders 1 (3.3) 1 (3.0)     1 (0.7) 1 (0.6)
Psychiatric disorders   1 (3.0)      
Renal and urinary disorders        
Reproductive system and breast disorders 9 (30.0) 11 (33.3) 12 (38.7) 12 (35.3) 13 (39.4) 1 (0.7) 1 (0.6)
Respiratory, thoracic and mediastinal disorders 1 (3.3)     1 (3.0)   
Skin and subcutaneous disorders     1 (2.9) 1 (3.0)   
Surgical and medical procedures       1 (0.7)  
Vascular disorders 1 (3.3)       1 (0.6)