Table 3.
Adverse events and drug-related adverse events
| [System Organ Class] Preferred term |
Adverse events
|
Drug-related adverse events
|
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 mg N=29 |
4 mg N=28 |
12 mg N=26 |
1 mg N=29 |
4 mg N=28 |
12 mg N=26 |
|||||||
| n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
| Patients with any events | 9 | 31.0 | 8 | 28.6 | 10 | 38.5 | 0 | 1 | 3.6 | 1 | 3.8 | |
| [Blood and lymphatic system disorders] | 3 | 10.3 | 1 | 3.6 | 0 | 0 | 0 | 0 | ||||
| Anemia | 2 | 6.9 | 1 | 3.6 | 0 | 0 | 0 | 0 | ||||
| Nephrogenic anemia | 1 | 3.4 | 0 | 0 | 0 | 0 | 0 | |||||
| [Cardiac disorders] | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| Supraventricular tachycardia | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| [Eye disorders] | 0 | 3 | 10.7 | 1 | 3.8 | 0 | 0 | 0 | ||||
| Conjunctival hemorrhage | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| Dry eye | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Optic nerve cupping | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Punctate keratitis | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| [Gastrointestinal disorders] | 0 | 2 | 7.1 | 2 | 7.7 | 0 | 1 | 3.6 | 1 | 3.8 | ||
| Vomiting | 0 | 1 | 3.6 | 1 | 3.8 | 0 | 1 | 3.6 | 0 | |||
| Diarrhea | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Nausea | 0 | 0 | 1 | 3.8 | 0 | 0 | 1 | 3.8 | ||||
| [General disorders and administration site condition] | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| Chest pain | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| [Infections and infestations] | 1 | 3.4 | 1 | 3.6 | 1 | 3.8 | 0 | 0 | 0 | |||
| Nasopharyngitis | 1 | 3.4 | 0 | 1 | 3.8 | 0 | 0 | 0 | ||||
| Pharyngitis | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| [Injury, poisoning, and procedural complications] | 1 | 3.4 | 1 | 3.6 | 1 | 3.8 | 0 | 0 | 0 | |||
| Shunt occlusion | 1 | 3.4 | 0 | 0 | 0 | 0 | 0 | |||||
| Vascular procedure complication | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Procedural nausea | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| [Investigations] | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| C-reactive protein increased | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| [Musculoskeletal and connective tissue disorders] | 1 | 3.4 | 0 | 0 | 0 | 0 | 0 | |||||
| Neck pain | 1 | 3.4 | 0 | 0 | 0 | 0 | 0 | |||||
| [Psychiatric disorders] | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Insomnia | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| [Renal and urinary disorders] | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Hematuria | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| [Reproductive system and breast disorders] | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| Breast mass | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| [Respiratory, thoracic, and mediastinal disorders] | 0 | 1 | 3.6 | 1 | 3.8 | 0 | 0 | 0 | ||||
| Rhinorrhea | 0 | 0 | 1 | 3.8 | 0 | 0 | 0 | |||||
| Upper respiratory tract inflammation | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| [Skin and subcutaneous tissue disorders] | 5 | 17.2 | 2 | 7.1 | 0 | 0 | 0 | 0 | ||||
| Dermatitis contact | 4 | 13.8 | 1 | 3.6 | 0 | 0 | 0 | 0 | ||||
| Dermal cyst | 0 | 1 | 3.6 | 0 | 0 | 0 | 0 | |||||
| Eczema | 1 | 3.4 | 0 | 0 | 0 | 0 | 0 | |||||