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

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

Diagnostic test nameDateTest valueTest units h) Relevant Diagnostic Tests Page 3 of 3 d d m m y y y y i) Causality and Expectedness h1) Are there any test / laboratory findings to record?* No (go to Section i) Yes (please give details) 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______________________________ _________________________________ 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 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. all follow up information for SUSARs to the Sponsor as soon as possible. Date Signed *Continue on SAE supplemental page CTT21 A if more space is required No (go to i2) i1) Is the SAE suspected to be related to the study treatments? Yes Expectedness Expected Unexpected (= SUSAR) Trial treatment name Expected Unexpected (= SUSAR) Expected Unexpected (= SUSAR) Page completed _________________________________ Date form completed d d m m y y y y i2) If no, what is the most likely cause? Disease (name) Other illness (specify) Other (specify) Concomitant medication (specify medication) PLEASE SAE REPORTS TO THE SPONSOR > within 24 hours of becoming aware of the SAE Serious Adverse Event (SAE) Report Patient initials Patient ID SAE ID CTT21_v6.0_151204