Table 3.
Treatment-emergent adverse events regardless of relationship to study drugs
| Adverse event | Grade 1 | Grade 2 |
|---|---|---|
| Dry skin | 6 | 1 |
| Alk Phos Increase | 4 | 0 |
| Nasopharyngitis | 3 | 0 |
| Pruritus | 2 | 0 |
| Fatigue | 2 | 0 |
| Dizziness | 3 | 0 |
| ALT/AST increase | 3 | 0 |
| Abnormal ECG | 0 | 2 |
| Prolonged QT | 1 | 0 |
| Tachycardia | 0 | 1 |
| Constipation | 1 | 0 |
| Hot Flush | 1 | 0 |
| Mouth Ulceration | 1 | 0 |
| Nausea | 1 | 0 |
| Vomiting | 1 | 0 |
| Gastrooesphageal Reflux | 1 | 0 |
| Hypersensitivity | 1 | 1 |
| Nipple infection | 1 | 0 |
| Sore throat | 1 | 0 |
| Viral pharyngitis | 1 | 0 |
| Arthralgia | 1 | 0 |
| Back pain/spinal pain/muscle spasm | 2 | 1 |
| Spinal osteoarthritis | 1 | 0 |
| Musculoskeletal discomfort | 0 | 1 |
| Pain in extremity | 1 | 1 |
| Headache | 1 | 0 |
| Breast mass | 1 | 1 |
| Dyspnoea | 1 | 0 |
| Syncope | 1 | 0 |
| Skin discolouration | 1 | 0 |
| Uticaria | 1 | 0 |
| Erythema | 1 | 0 |
| Thrombocytosis | 1 | 0 |
| Glycosuria | 0 | 1 |
| Proteinura | 1 | 0 |
| Hypermagnesaemia | 1 | 0 |
| Hypernatraemia | 1 | 0 |
| Hyperphosphatemia | 1 | 0 |
| Vitamin D deficiency | 1 | 0 |