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Table 1 Classification of adverse drug reaction (ADR) severity for Shenmai injection

From: Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

Classification of ADR severity

 

Class I

ADRs are deadly or life-threatening; patients need to be withdrawn from drugs and treated immediately; or ADRs last for more than 1 month.

Class II

Patients have pathologic and physiologic changes and must be withdrawn from drugs and treated; or ADRs last for more than 7 days.

Class III

Patients cannot endure the ADRs and must be given a lower dose or withdrawn from drugs; patients improve after symptomatic treatment.

Class IV

Patients can endure the ADRs, and no lowering of dose or drug withdrawal is necessary. Whether without treatment or through symptomatic treatment, patients improve