Table 3.
Serious adverse events. Serious Adverse Events (SAEs) presented per cohort CQ. The adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.03)
Dose level [mg] | SAE | CTCAE grade | Related to CQ | Action taken |
---|---|---|---|---|
200 | Confusion | III | Unrelated | No adjuvant temozolomide |
Seizure | I | Unrelated | Increase dose anticonvulsants | |
Fall (Trauma capitis) | II | Possibly | No action | |
Thromboembolic event | IV | Unlikely | Anticoagulants | |
Thromboembolic event | V | Unlikely | None | |
Diarrhea | III | Possibly | i.v. fluids | |
Nausea | III | Possibly | Stop chloroquine | |
Vomiting | III | Possibly | Stop chloroquine | |
300 | Nausea | III | Possibly | Stop chloroquine Stop temozolomide Stop radiotherapy |
400 | Hypercalcemia | II | Unlikely | i.v. fluids/bisphosphonates |
Blurred vision | III | Probably | Stop chloroquine | |
Hallucinations | IV | Unrelated | Haloperidol |
Serious Adverse Events (SAEs) presented per cohort CQ. The adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.03).