Table 2.
Adverse events (n = 99), listed and graded according to the Common Terminology Criteria for Adverse Events
| Adverse event | Grade 1 (mild) (n = 72) | Grade 2 (moderate) (n = 27) | ||
|---|---|---|---|---|
| Subtype | n | Subtype | n | |
| Blood and lymphatic system disorder | Anemia | 2 | Other, pancytopenia | 2 |
| Eye disorders | Dry eye | 1 | — | — |
| Gastrointestinal disorders | Bloating | 1 | Gastroesophageal reflux disease | 3 |
| Dyspepsia | 2 | Mucositis oral | 1 | |
| Gastroesophageal reflux disease | 1 | Pancreatitis | 1 | |
| Gastrointestinal pain | 1 | |||
| Nausea | 5 | |||
| Vomiting | 1 | |||
| General disorders and administration site conditions | Fatigue | 3 | Fatigue | 2 |
| Fever | 1 | Flu like symptoms | 1 | |
| Flu like symptoms | 1 | Malaise | 1 | |
| Hepatobiliary disorders | Other, hepatic steatosis | 1 | — | — |
| Infections and infestations | Vaginal infection | 1 | Hepatitis viral | 1 |
| Urinary tract infection | 1 | |||
| Injury, poisoning, and procedural complications | Bruising | 1 | — | — |
| Investigations | Elevated liver enzymes | 25 | CPK increased | 1 |
| Hypophosphatemia | 1 | Elevated liver enzymes | 1 | |
| Platelet count decreased | 1 | Lipase increased | 1 | |
| White blood cell decreased | 5 | Platelet count decreased | 1 | |
| White blood cell decreased | 1 | |||
| Musculoskeletal and connective tissue disorders | Back pain | 1 | Myalgia | 3 |
| Muscle cramp | 2 | |||
| Myalgia | 2 | |||
| Nervous system disorders | Dizziness | 1 | — | — |
| Respiratory, thoracic, and mediastinal disorders | Cough | 1 | — | — |
| Skin and subcutaneous tissue disorders | Alopecia | 2 | Dry skin | 1 |
| Hair color changes | 1 | Other, hidradenitis suppurativa | 1 | |
| Other, hidradenitis suppurativa | 1 | Other, periorificial dermatitis | 1 | |
| Other, mycosis | 1 | Rash not specified | 1 | |
| Pruritus | 1 | |||
| Purpura | 1 | |||
| Rash acneiform | 2 | |||
| Rash not specified | 1 | |||
| Skin hypopigmentation | 1 | |||
| Vascular disorders | — | — | Thromboembolic event | 2 |