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Table 5 Adverse drug reaction (ADR)

From: Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

Unrelated

An adverse event (AE) that is not related to drug use

Unlikely

An AE for which an alternative explanation is more likely (e.g., concomitant drugs and diseases), or the relationship in time suggests that a causal relationship is unlikely

Possible

An AE that might be caused by drug use. An alternative explanation (e.g., concomitant drugs and diseases) is inconclusive. The relationship in time is reasonable; therefore, the causal relationship cannot be excluded

Probable or likely

An AE that might be due to drug use. The relationship in time is suggestive (e.g., confirmed by a dechallenge). An alternative explanation is less likely (e.g., concomitant drugs or diseases)

Certain

An AE that is listed as a possible ADR and cannot be reasonably explained by an alternative explanation (e.g., concomitant drugs and diseases). The relationship in time is highly suggestive; it is confirmed by a dechallenge and rechallenge