Table 1.
Event | Grade 1 | Grade 2 | Grade 3 | Total |
---|---|---|---|---|
no. | no. (%) | |||
Cardiac disorders | ||||
Bradycardia | 2 | 0 | 0 | 2 (17) |
Hypertension | 1 | 0 | 0 | 1 (8) |
Hypotension | 1 | 0 | 0 | 1 (8) |
Tachycardia | 1 | 0 | 0 | 1 (8) |
Ear and labyrinth disorders: external ear inflammation | 0 | 1 | 0 | 1 (8) |
Gastrointestinal disorders | ||||
Abdominal pain | 1 | 0 | 0 | 1 (8) |
Constipation | 1 | 0 | 0 | 1 (8) |
Diarrhea | 3 | 0 | 0 | 3 (25) |
Nausea | 2 | 0 | 0 | 2 (17) |
Vomiting | 3 | 2 | 0 | 5 (42) |
General disorders | ||||
Chills | 1 | 0 | 0 | 1 (8) |
Fatigue | 3 | 0 | 0 | 3 (25) |
Fever | 4 | 0 | 0 | 4 (33) |
Blood and lymphatic system: anemia | 1 | 0 | 1 | 2 (17) |
Infections and infestations: perirectal abscess | 0 | 0 | 1 | 1 (8) |
Procedural complications: postoperative hemorrhage | 6 | 0 | 0 | 6 (50) |
Investigations | ||||
Increased ALT level | 0 | 1 | 1 | 2 (17) |
Increased AST level | 0 | 2 | 0 | 2 (17) |
Decreased lymphocyte count | 0 | 0 | 1 | 1 (8) |
Decreased neutrophil count | 1 | 0 | 1 | 2 (17) |
Decreased platelet count | 3 | 0 | 0 | 3 (25) |
Weight loss | 1 | 0 | 0 | 1 (8) |
Decreased white-cell count | 0 | 1 | 1 | 2 (17) |
Metabolism and nutrition | ||||
Anorexia | 2 | 0 | 0 | 2 (17) |
Hyperphosphatemia | 1 | 0 | 0 | 1 (8) |
Obesity | 0 | 0 | 1 | 1 (8) |
Nervous system disorders | ||||
Cerebrospinal fluid leak | 0 | 1 | 0 | 1 (8) |
Dizziness | 1 | 0 | 0 | 1 (8) |
Facial nerve disorder | 1 | 0 | 0 | 1 (8) |
Headache | 2 | 1 | 0 | 3 (25) |
Peritumoral vasogenic edema | 0 | 1 | 0 | 1 (8) |
Seizure | 2 | 0 | 0 | 2 (17) |
Skin disorders: contact dermatitis | 1 | 1 | 0 | 2 (17) |
Total | 45 | 11 | 7 | 63 |
Shown is the cumulative incidence of adverse events according to highest grade irrespective of cause within 30 days after G207 administration. There were no events of grade 4. ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.