The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information.

Control (standard patient leaflet)

The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet.

Patient leaflet with the EMA's proposed key information section including qualitative statements.

The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects.

Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.

London School of Economics and Political Science

Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).

침대 상승을 통한 위 내용물 양의 정성적 및 정량적 평가, 침대 상승 없이 위 내용물 양의 정성적 및 정량적 평가