Observed Adverse Events
| . | N (%) . | Events (%) . |
|---|---|---|
| Any adverse event | 32 (86.5) | 192 (100) |
| Body as a whole | ||
| Fever | 27 (73.0) | 55 (28.6) |
| Chills | 14 (37.8) | 14 (7.3) |
| Asthenia | 6 (16.2) | 6 (3.1) |
| Headache | 6 (16.2) | 11 (5.7) |
| Cardiovascular system | ||
| Hypotension | 6 (16.2) | 6 (3.1) |
| Digestive system | ||
| Nausea | 7 (18.9) | 7 (3.6) |
| Vomiting | 4 (10.8) | 4 (2.1) |
| Dyspepsia | 2 (5.4) | 2 (1.0) |
| Blood and lymphatics | ||
| Thrombocytopenia | 7 (18.9) | 7 (3.6) |
| Neutropenia | 3 (8.1) | 5 (2.6) |
| Anemia | 2 (5.4) | 3 (1.6) |
| Coagulation disorder | 2 (5.4) | 2 (1.0) |
| Leukopenia | 1 (2.7) | 4 (2.1) |
| Nervous system | ||
| Vasodilation | 1 (2.7) | 3 (1.6) |
| Respiratory system | ||
| Rhinitis | 6 (16.2) | 6 (3.1) |
| Laryngismus | 4 (10.8) | 4 (2.1) |
| Chest pain | 2 (5.4) | 2 (1.0) |
| Skin and appendages | ||
| Rash | 5 (13.5) | 5 (2.6) |
| Night sweats | 3 (8.1) | 3 (1.6) |
| Urticaria | 3 (8.1) | 4 (2.1) |
| Pruritus | 2 (5.4) | 3 (1.6) |
| Special senses | ||
| Lacrimation disorder | 5 (13.5) | 5 (2.6) |
| . | N (%) . | Events (%) . |
|---|---|---|
| Any adverse event | 32 (86.5) | 192 (100) |
| Body as a whole | ||
| Fever | 27 (73.0) | 55 (28.6) |
| Chills | 14 (37.8) | 14 (7.3) |
| Asthenia | 6 (16.2) | 6 (3.1) |
| Headache | 6 (16.2) | 11 (5.7) |
| Cardiovascular system | ||
| Hypotension | 6 (16.2) | 6 (3.1) |
| Digestive system | ||
| Nausea | 7 (18.9) | 7 (3.6) |
| Vomiting | 4 (10.8) | 4 (2.1) |
| Dyspepsia | 2 (5.4) | 2 (1.0) |
| Blood and lymphatics | ||
| Thrombocytopenia | 7 (18.9) | 7 (3.6) |
| Neutropenia | 3 (8.1) | 5 (2.6) |
| Anemia | 2 (5.4) | 3 (1.6) |
| Coagulation disorder | 2 (5.4) | 2 (1.0) |
| Leukopenia | 1 (2.7) | 4 (2.1) |
| Nervous system | ||
| Vasodilation | 1 (2.7) | 3 (1.6) |
| Respiratory system | ||
| Rhinitis | 6 (16.2) | 6 (3.1) |
| Laryngismus | 4 (10.8) | 4 (2.1) |
| Chest pain | 2 (5.4) | 2 (1.0) |
| Skin and appendages | ||
| Rash | 5 (13.5) | 5 (2.6) |
| Night sweats | 3 (8.1) | 3 (1.6) |
| Urticaria | 3 (8.1) | 4 (2.1) |
| Pruritus | 2 (5.4) | 3 (1.6) |
| Special senses | ||
| Lacrimation disorder | 5 (13.5) | 5 (2.6) |
Included are events reported as possibly or probably related or of unknown relationship to study treatment.
Abbreviations: N, number of patients; Events, number of events.