Intensity Classification Clause Samples

Intensity Classification. AEs will be classified as mild, moderate or severe according to the following criteria: • Mild: symptoms do uot alter the subject's uormal functioning • Moderate: symptoms produce some degree of impairment to function, but are not hazardous, uncomfortable or embarrassing to the subject • Severe: symptoms definitely hazardous to wellbeing, significant impairment of function or incapacitation.