Criteria for discontinuing or modifying allocated interventions {11b}
allergic reaction
ADVERSE EVENT, ADVERSE REACTION, ALLERGIC REACTION
A patient can withdraw from the study at any time, or when medically necessary, as judged by the investigator. If withdrawal of consent occurs, the data of the patient will be used until the date of withdrawal. If the patient withdraws consent due to an adverse event (AE) or adverse reaction (AR), the patient will be followed until the AE/AR is resolved.The dose of the study medication will be fixed. In case of any clinical signs of an allergic reaction or severe side effects are suspected, the infusion will be terminated immediately. No dosage adjustments are allowed.