2.9. Withdrawal criteria and management
massive deterioration
ADVERSE EVENT
Patients may or must withdraw from the study if the continuation of the study imposes an unreasonable burden on the patient because of the patient condition, if a serious adverse event occurs and a causal relationship is established by the study director, if patients request withdrawal from the study and/or there is a lack of willingness to cooperate or comply, and/or if circumstances arise that make continued participation unreasonable, such as massive deterioration in health due to serious illness.Reasons and timing of withdrawal will be recorded in standard case report forms and stored in the study database.