Details of the reason for withdrawal should be recorded in the patient’s Case Report Form. All patients should continue to be included in the assessments of their safety and efficacy. Patient s who withdraw should, if possible, have a follow -up examination (withdrawal visit), including a physical examination, the appropriate investigations, vital signs, and clinical laboratory tests. All details of this follow -up examination should be recorded in the pati ent’s medical source documents. Then unless patients withdrew their consent, a survival follow -up visit should be done every 6 months after the initial 2 years of study period and until the last remaining patient in the modified cohort reaches the 2 years study period or withdraws consent or experiences toxicity, whichever is the earliest . Thereafter, a survival follow -up will continue to be performed approximately every 12 months until end of life. 3.3.3.1 Patient withdrawal Participation in the trial is strictly voluntary. Patients are free to discontinue the trial at any time without giving their reason(s). If a patient withdraws from the trial, the Investigators are to be informed immediately. A patient must be withdrawn from the trial treatment in the event of any of the following: • withdrawal of the patient’s consent • occurrence of an exclusion criterion which is clinically relevant and affects the patient’s safety, and discontinuation is considered necessary by the Investigators and/or Targovax • recurrence of pancreatic cancer with no immune response CT TG01 -01 Version v 10.0 27 June 2018 Confidential 50 / 87 • occurrence of AEs, if discontinuation of trial medication is desired or considered necessary by the Investigator and/or patient (if applicable) • occurrence of pregnancy • intake of non- permitted concomitant medication as defined in Section 4.6 where the predefined consequence is withdrawal from the trial • lack of patient compliance • protocol violation If a patient fails to attend scheduled assessments during the course of the trial, the Investigators must dete rmine the reasons and the circumstances as completely and accurately as possible and document this in the patient’s medical source documents. All patients who withdraw from the trial for any reason and at any time should have an end of study examination (withdrawal visit). Patients will be examined for any status changes that require further follow -up. Any new medical condition or event occurring during the trial will be followed until the patient is stable and able to resume care by his/her physician. 3.3.3.2 Trial discontinuation The whole trial may be discontinued at the discretion of the PI or the sponsor in the event of any of the following: • occurrence of AEs unknown to date in respect of their nature, severity and duration, or the unexpected incidence of known AEs • medical or ethical reasons affecting the continued performance of the trial • difficulties in the recruitment of patients • cancellation of drug development. 3.3.3.3 Procedures for discontinuation Subjects who discontinue should always be asked about the reason(s) for their discontinuation and the presence of any adverse events. If possible, they should be seen and assessed by an investigator(s).