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. 2020 Sep 20;17(9):2604–2612. doi: 10.1080/15548627.2020.1816343

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).