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.