Table 2 Trial specific German numeric rating scale to assess the severity of agitation and to evaluate the efficacy of the investigational medicinal product

Restlessness

3 Severe restlessness Patient is restless, shows tendency to get up and run away (flight from bed). Is at risk of falling. Patient is agitated, +/- in constant movement. Eyes usually wide open, no eye contact possible and patient strongly disoriented, often calls for the nurse. Patient is very anxious.

2 Restlessness Increased urge to move, +/- tendency to get up, +/- makes verbal expressions such as “go home”/“(leave here)”. Various signs of anxiety: patient expresses anxiety, +/- anxious look. Patient is partially disoriented. Respiratory rate may be increased.

1 Mild restlessness Patient calls or rings and does not know why. Still responds or responds again when spoken to. May be tense (facial expression and posture), +/- fidgeting and restless hands.

0 Calm Patient is calm and relaxed: gestures and facial expressions are relaxed. Patient returns the gaze or is asleep.

Defensive reactions

3 Strong defence Patient shows defensive behaviour with hands, +/- feet. Pulling on supply/infusion lines. Attempts to climb over the bed rail. Strong clinging, uncontrolled grasping and grabbing, +/- grabs nurse’s arms. rejects everything and doesn’t tolerate anything in close proximity: Wants everything away from the body and will allow nothing.

2 Defensive tensing of extremities. Patient becomes “stiff” and cramped, +/- clings to bed rail.

1 Mild defence Patient turns away. Slight tension when touched or positioned.

0 No defence

Disorientation

3 Severe disorientation Patient is temporally, spatially, +/- personally disoriented. May have delusions and/or hallucinations, +/- feels threatened. May be aggressive. Verbal communication is not possible, patient is no longer communicatively accessible.

2 Disorientation Patient disoriented in time +/- location. Often rings bell and does not know why. Searches for things and moves around a lot. Hangs on thoughts - “must go to the toilet”/“must call wife”/“must call doctor”.

1 Mild disorientation Patient notices own disorientation, can be “taught”/disorientation reversible by addressing and explaining, contact is still possible or possible again.

0 Orientation

Verbal expressions

Patient is restless - “go out”/“go where”/“go home”. Expressions such as: “want to go to a person”/calling out names. Patient feels they need to do something.

Facial expressions

High reddened head, tense jaw muscles, grimaces, forehead wrinkles