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In a randomized, double-blind trial comparing therapy with EMCYT (estramustine) Capsules in 93 patients (11.5 to 15.9 mg/kg/day) or diethylstilbestrol (DES) in 93 patients (3.0 mg/day), the following adverse effects were reported:

  EMCYT
n=93
DES
n=93
CARDIOVASCULAR-RESPIRATORY
  Cardiac Arrest 0 2
  Cerebrovascular Accident 2 0
  Myocardial Infarction 3 1
  Thrombophlebitis 3 7
  Pulmonary Emboli 2 5
  Congestive Heart Failure 3 2
  Edema 19 17
  Dyspnea 11 3
  Leg Cramps 8 11
  Upper Respiratory Discharge 1 1
  Hoarseness 1 0
GASTROINTESTINAL
  Nausea 15 8
  Diarrhea 12 11
  Minor Gastrointestinal Upset 11 6
  Anorexia 4 3
  Flatulence 2 0
  Vomiting 1 1
  Gastrointestinal Bleeding 1 0
  Burning Throat 1 0
  Thirst 1 0
INTEGUMENTARY
  Rash 1 4
  Pruritus 2 2
  Dry Skin 2 0
  Pigment Changes 0 3
  Easy Bruising 3 0
  Flushing 1 0
  Night Sweats 0 1
  Fingertip-Peeling Skin 1 0
  Thinning Hair 1 1
BREAST CHANGES
  Tenderness 66 64
Enlargement    
  Mild 60 54
  Moderate 10 16
  Marked 0 5
MISCELLANEOUS
  Lethargy Alone 4 3
  Depression 0 2
  Emotional Lability 2 0
  Insomnia 3 0
  Headache 1 1
  Anxiety 1 0
  Chest Pain 1 1
  Hot Flashes 0 1
  Pain in Eyes 0 1
  Tearing of Eyes 1 1
  Tinnitus 0 1
LABORATORY ABNORMALITIES
Hematologic    
  Leukopenia 4 2
  Thrombopenia 1 2
Hepatic    
  Bilirubin Alone 1 5
  Bilirubin and LDH 0 1
  Bilirubin and SGOT 2 1
  Bilirubin, LDH and SGOT 2 0
  LDH and/or SGOT 31 28
Miscellaneous    
  Hypercalcemia-Transient 0 1