Incidence of most frequent related adverse events
| . | Grade . | Total . | |||
|---|---|---|---|---|---|
| 1 . | 2 . | 3 . | 4 . | N (%) . | |
| Any adverse event | 14 | 11 | 3 | 0 | 28 (93) |
| Body as a whole | |||||
| Asthenia | 6 | 6 | 0 | 0 | 12 (40) |
| Chills | 7 | 4 | 0 | 0 | 11 (37) |
| Headache | 7 | 1 | 0 | 0 | 8 (27) |
| Fever | 7 | 0 | 0 | 0 | 7 (23) |
| Throat irritation | 4 | 1 | 0 | 0 | 5 (17) |
| Flushing | 4 | 0 | 0 | 0 | 4 (13) |
| Abdominal pain | 3 | 0 | 1 | 0 | 4 (13) |
| Back pain | 2 | 2 | 0 | 0 | 4 (13) |
| Mucous membrane disorder | 0 | 3 | 0 | 0 | 3 (10) |
| Cardiovascular system | |||||
| Hypotension | 1 | 2 | 0 | 0 | 3 (10) |
| Digestive system | |||||
| Nausea | 6 | 4 | 0 | 0 | 10 (33) |
| Vomiting | 5 | 2 | 0 | 0 | 7 (23) |
| Dry mouth | 2 | 1 | 0 | 0 | 3 (10) |
| Hemic and lymphatic system | |||||
| Ecchymosis | 2 | 1 | 0 | 0 | 3 (10) |
| Metabolic and nutritional disorders | |||||
| Angioedema | 3 | 0 | 0 | 0 | 3 (10) |
| Musculoskeletal system | |||||
| Myalgia | 1 | 2 | 0 | 0 | 3 (10) |
| Nervous system | |||||
| Dizziness | 3 | 1 | 0 | 0 | 4 (13) |
| Paresthesia | 4 | 0 | 0 | 0 | 4 (13) |
| Respiratory system | |||||
| Increased cough | 5 | 0 | 0 | 0 | 5 (17) |
| Bronchospasm | 3 | 1 | 0 | 0 | 4 (13) |
| Rhinitis | 3 | 1 | 0 | 0 | 4 (13) |
| Dyspnea | 2 | 1 | 0 | 0 | 3 (10) |
| Skin and appendages | |||||
| Pruritus | 4 | 3 | 0 | 0 | 7 (23) |
| . | Grade . | Total . | |||
|---|---|---|---|---|---|
| 1 . | 2 . | 3 . | 4 . | N (%) . | |
| Any adverse event | 14 | 11 | 3 | 0 | 28 (93) |
| Body as a whole | |||||
| Asthenia | 6 | 6 | 0 | 0 | 12 (40) |
| Chills | 7 | 4 | 0 | 0 | 11 (37) |
| Headache | 7 | 1 | 0 | 0 | 8 (27) |
| Fever | 7 | 0 | 0 | 0 | 7 (23) |
| Throat irritation | 4 | 1 | 0 | 0 | 5 (17) |
| Flushing | 4 | 0 | 0 | 0 | 4 (13) |
| Abdominal pain | 3 | 0 | 1 | 0 | 4 (13) |
| Back pain | 2 | 2 | 0 | 0 | 4 (13) |
| Mucous membrane disorder | 0 | 3 | 0 | 0 | 3 (10) |
| Cardiovascular system | |||||
| Hypotension | 1 | 2 | 0 | 0 | 3 (10) |
| Digestive system | |||||
| Nausea | 6 | 4 | 0 | 0 | 10 (33) |
| Vomiting | 5 | 2 | 0 | 0 | 7 (23) |
| Dry mouth | 2 | 1 | 0 | 0 | 3 (10) |
| Hemic and lymphatic system | |||||
| Ecchymosis | 2 | 1 | 0 | 0 | 3 (10) |
| Metabolic and nutritional disorders | |||||
| Angioedema | 3 | 0 | 0 | 0 | 3 (10) |
| Musculoskeletal system | |||||
| Myalgia | 1 | 2 | 0 | 0 | 3 (10) |
| Nervous system | |||||
| Dizziness | 3 | 1 | 0 | 0 | 4 (13) |
| Paresthesia | 4 | 0 | 0 | 0 | 4 (13) |
| Respiratory system | |||||
| Increased cough | 5 | 0 | 0 | 0 | 5 (17) |
| Bronchospasm | 3 | 1 | 0 | 0 | 4 (13) |
| Rhinitis | 3 | 1 | 0 | 0 | 4 (13) |
| Dyspnea | 2 | 1 | 0 | 0 | 3 (10) |
| Skin and appendages | |||||
| Pruritus | 4 | 3 | 0 | 0 | 7 (23) |
Includes most frequent events (≥ 10%) that occurred during the treatment period considered as probable, possible, or of unknown relationship to study treatment in 30 patients. Each patient was counted only once according to worst adverse event grade experienced. Excludes neutropenia, leukopenia, thrombocytopenia, and anemia.