*Continue on SAE supplemental page CTT21 A if more space is required Serious Adverse Event (SAE) Report Patient initials Patient ID Page 1 of 3 SAE ID Please indicate whether it is a SAE or SUSAR being reported: SAE SUSAR EudraCT Number: Sponsor ID: Source of report: Clinical Trial Report Type: Initial Follow-up Country: a) Patient data a5) Date of Birth a2) Gender: a3) Height cm a4) Weight kg d d m m y y y y a1) Age (yrs) b) Serious adverse event information b1) Date of onset of first sign/symptom of SAE d d m m y y y y b2) Date of awareness d d m m y y y y b3) SAE in medical terms (diagnosis, if possible) b4) Case description of the above SAE (including signs/symptoms, treatment, course/outcome and suspected cause of the SAE)* c) Seriousness criteria c1) Patient died c5) Congenital anomaly/birth defect c2) Life threatening c6) Surgical/medical intervention to prevent one of the above (if yes, please briefly outline below:) c3) Persistent or significant disability/incapacity c4) Involved/prolonged in-patient hospitalisation d) Outcome at the time of this report d1) Recovered Date of recovery d d m m y y y y d3) Not Recovered d2) Recovering d5) Fatal Was a post-mortem undertaken? Yes No Was the SAE ongoing at time of death from other cause? d d m m y y y y d4) Recovered with sequelae e1) Please enter details of any “relevant” prior diseases the patient has suffered that are not being treated by the study medication.* e) Patient’s medical history Name of conditions. (Continue if necessary on a separate sheet) a. Start d d m m y y y y End d d m m y y y y Ongoing b. Start d d m m y y y y End d d m m y y y y Ongoing e2) Please enter details of any concomitant medication the patient has taken in the last 3 months* Name of drugs, (if more than 2 drugs please add separately) d d m m y y y y Start End a. b. Page completed by________________________________ Date form completed d d m m y y y y *Continue on SAE supplemental page CTT21 A if more space is required CTT21_v6.0_151204

*Continue on SAE supplemental page CTT21 A if more space is required Serious Adverse Event (SAE) Report Patient initials Patient ID Page 2 of 3 SAE ID f) IMP information f1) Initial trial medication* Initial trial medication Date of initial dose Trial dose /units Route Frequency Drug name: d d m m y y y y d d m m y y y y d d m m y y y y f2) Trial medication at the time of the SAE* Trial medication Date most recent dose Most recent trial medication: Action taken Date treatment stopped (if applicable) Drug name: Treatment delayed Treatment Stopped Dose / Units Route None Dose Reduction* *% Decrease Frequency d d m m y y y y d d m m y y y y d d m m y y y y d d m m y y y y d d m m y y y y d d m m y y y y g) Treatment for the SAE g1) Was treatment given for the SAE?* Yes (please give details) No (go to Section h) Name of the treatment Dose Units Route Frequency Page completed _________________________________ Date form completed d d m m y y y y *Continue on SAE supplemental page CTT21 A if more space is required CTT21_v6.0_151204

*Continue on SAE supplemental page CTT21 A if more space is required SAE ID Serious Adverse Event (SAE) Report Patient initials Patient ID Page 3 of 3 h) Relevant Diagnostic Tests h1) Are there any test / laboratory findings to record?* No (go to Section i) Yes (please give details) Diagnostic test name Date Test value Test units d d m m y y y y d d m m y y y y d d m m y y y y d d m m y y y y i) Causality and Expectedness No (go to i2) i1) Is the SAE suspected to be related to the study treatments? Yes Expectedness Expected Unexpected (= SUSAR) Trial treatment name i2) If no, what is the most likely cause? Disease (name) Other illness (specify) Other (specify) Concomitant medication (specify medication) THE SAE MUST BE REVIEWED AND THIS SECTION COMPLETED BY THE INVESTGATOR OR AN AUTHORISED, CLINICALLY QUALIFIED DELEGATE. Refer to the SPC / IB containing the trial’s Reference Safety Information Name _________________________________ Position _______________________________ Signature______________________________ Email_________________________________ Address _____________________________ _____________________________ Tel. No. _____________________________ Date ______________________________ j) SUSAR Confirmation by Chief Investigator All suspected SUSARS must be reviewed by the CHIEF INVESTIGATOR. Chief Investigator signature to confirm formal review of this event as a SUSAR Date Signed Please note: All suspected SUSARs MUST be sent to the sponsor within 24 hours of awareness for reporting to the regulator even if the CI is not available. CI review can take place after this time and a SUSAR can be downgraded at a later date. THE SPONSOR WILL REPORT SUSARS TO THE MHRA & REC. E-mail all follow up information for SUSARs to the Sponsor as soon as possible. Page completed _________________________________ Date form completed d d m m y y y y *Continue on SAE supplemental page CTT21 A if more space is required PLEASE E-MAIL SAE REPORTS TO THE SPONSOR <<leedsth-tr.sponsorqa@nhs.net>> within 24 hours of becoming aware of the SAE CTT21_v6.0_151204