Table 1.
Patient | Dose at time of reporting (mg/day) | Question 2 | Question 3 | Question 5 | Question 9 | Question 10 | Total score | Possibility of ADR* |
---|---|---|---|---|---|---|---|---|
A | 200 | 2 | 0 | −1 | 0 | 0 | 1 | Possible |
B | 200 | 2 | 1 | −1 | 0 | 0 | 2 | Possible |
C | 100 | 2 | 1 | −1 | 0 | 0 | 2 | Possible |
D | 300 | 2 | 1 | −1 | 0 | 0 | 2 | Possible |
E | 200 | 2 | 0 | −1 | 0 | 0 | 1 | Possible |
F | 200 | 2 | 1 | 2 | 0 | 0 | 5 | Probable |
G | 1200 | 2 | 0 | −1 | 0 | 0 | 1 | Possible |
Median dose 200 mg/day, with a range of 100–1200 mg/day.
Q2: Did the adverse event occur after the suspected drug was administered?
Q3: Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?
Q5: Are there alternative causes (other than the drug) that could have on their own caused the reaction?
Q9: Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
Q10: Was the adverse event confirmed by any objective evidence including clinician observation.
*According to modified Naranjo checklist.
ADR, adverse drug reaction; NCI CTCAE, National Cancer Institute's Common Toxicity Criteria for Adverse Events.