ADVERSE REACTIONS
In a randomized, double-blind trial comparing therapy with EMCYT 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 |