Outcome | Measurement of variable (units) | Statistical estimates and measurement of association of this outcome |
---|---|---|
Menstrual regulation | Number of girls achieved regular menses | Rate ratio |
Number of cycles per year | Mean difference ± SD | |
Hirsutism | Ferriman Gallawey score | Mean difference ± SD |
Acne scores | Lesion counting or grading | Standardized mean difference ± SD |
Dysglycaemia | The rate of occurrence of T2DM, impaired glucose tolerance, and impaired fasting glucose assessed by oral glucose tolerance test and/or fasting blood glucose, and/or HBA1c | Rate ratio |
BMI | kg/m2 | Mean difference ± SD |
Total testosterone level | ng/ml | Mean difference ± SD |
Total cholesterol | mg/dl | Mean difference ± SD |
LDL | mg/dl | Mean difference ± SD |
HDL | mg/dl | Mean difference ± SD |
Triglyceride | mg/dl | Mean difference ± SD |
Adverse events | Number of girls developed: | OR, rate ratio |
1- GI: all GI related adverse events: | ||
• Nausea | ||
• Vomiting | ||
• Diarrhea | ||
• Constipation | ||
• Abdominal pain | ||
• Flatulence | ||
• Gastritis | ||
• GI bleeding | ||
2- thrombosis: all vascular events related to thrombus formation such as: | ||
• Deep venous thrombosis | ||
• Stroke | ||
• Myocardial infarction | ||
• Pulmonary embolism | ||
3- serious: adverse events that are of major morbidity such as: | ||
• Any bleeding not including GI bleed | ||
• Lactic acidosis | ||
• Liver failure | ||
• Renal failure | ||
• Vasculitis | ||
• Electrolyte imbalance | ||
• Agranulocytosis | ||
• Photosensitivity | ||
• Hypertension | ||
• Pancreatitis | ||
• Anaphylaxis | ||
• Chorea | ||
• Depression | ||
4- minor: adverse events that are of minor morbidity such as: | ||
• Headache | ||
• Fatigue | ||
• Beast tenderness | ||
• Vaginal bleeding (spotting) | ||
• Edema | ||
• Weight gain | ||
• Metallic taste | ||
• Muscle cramp | ||
• Rash | ||
• Fever | ||
• Hot flashes | ||
• Glucose intolerance | ||
• Infection |