1. SAE Report CTT21 V5.0 131021 To:Quality Assurance Research & Development 34 Hyde Terrace LS2 9LN Date:…………………………….. Fax To:+44(0)113 392 6397 From (name):……………………….. ……… Location:……………………………….. Address: Tel: Fax: Sponsor SAE Report Form FOR SPONSOR QUALITY ASSURANCE OFFICE USE ONLY…………………… Please note: this fax sheet will be returned to the sender to confirm receipt and to notify the anticipated response time from the Quality Assurance department:- No queries identified – please send follow up report/any additional information as soon as possible. Queries identified - Quality Assurance will respond to this SAE within ……………. working days with any required action. Signed:Dated: Please Complete All sections Leeds Sponsor ID: _______/_______Trial Short Name:………………………… Patient Trial ID:______________SAE ID: __ __ __ __ / __ __ __ __ / __ __ __ __ Number of Pages (including SAE Form Supplemental page CTT21 A if required) ________ This report is:Initial Follow Up This SAE is a SUSAR:Yes No This SAE requires un-blinding?Yes No (R&D number / Patient ID / SAE number) Page 1 of 4

2. SAE Report CTT21 V5.0 131021 Serious Adverse Event (SAE) Report Patient initials Patient ID Centre NumberTrial Number EudraCT Number: Report Type: Initial Follow-upCountry Sponsor ID: Source of report: Clinical Trial a2) Gender: a1) Age (yrs) a) Patient data Male Female PLEASE FAX SAE REPORTS TO THE SPONSOR > within 24 hours of becoming aware of the SAE. THE SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax all follow up information for SUSARs to the Sponsor as soon as possible. Page completed by_________________________________________Date form completed d d m m y y y y Page 2 of 4 b4 ) Case description of the above SAE (including signs/symptoms, treatment, course/outcome and suspected cause of the SAE) (continue on SAE supplemental page CTT21 A section b4i if more space is required) 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 d) Outcome at the time of this report d1) Recovered Date of recovery d2) Recovering d3) Not Recovered d4) Recovered with sequelae d5) Fatal Was a post-mortem undertaken?YesNo Was the SAE ongoing at time of death from other cause? YesNo e1) Please enter details of any “relevant” prior diseases the patient has suffered that are not being treated by the study medication. (continue on SAE supplemental page CTT21 A section e4i if more space is required) e) Patient’s medical history Name of conditions, Repeat 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 non-study medication that the patient has taken outside of the last 3 months. Any medication taken within the last 3 months should be entered as Concomitant (continue on SAE supplemental page CTT21 A section e2i if more space is required) startend d d m m y y y y startend ongoing d d m m y y y y startend a. b. a. d d m m y y y y startend b. ongoing

3. SAE Report CTT21 V5.0 131021 g1 ) Was treatment given for the SAE?Yes (please give details) No (go to Section h) Continue on SAE supplemental page CTT21 A section g1i if more space is required Tick if using Page 3 of 4 Serious Adverse Event (SAE) Report Patient initials Patient ID Centre NumberTrial Number f) Trial Medicinal Information f1 ) First trial medicinal information(continue on SAE supplemental page CTT21 A section f1i if more space is required) First ever trial medicationStart date 1 st ever trial dose 1 st ever trial dose 1 st ever trial units 1 st ever trial route 1 st ever trial frequency Drug name: f2 ) Trial medicinal information at the time of the SAE (continue on SAE supplemental page CTT21 A section f2i if more space is required) Trial medicationDate most recent dose Most recent trial medication: Action takenIf treatment stopped: Stop date Drug name: d d m m y y y y Dose UnitsRouteFrequencyNone*% Decrease Dose Reduction* Treatment Stopped Treatment delayed Sponsor note: Section f to be updated with all trial drug names at the beginning of the trial. PLEASE FAX SAE REPORTS TO THE SPONSOR > within 24 hours of becoming aware of the SAE. THE SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax follow up information for SUSARs to the Sponsor as soon as possible. Page completed by_________________________________________Date form completed d d m m y y y y g) Treatment for the SAE Name of the treatmentDoseUnitsRouteFrequency n/a

4. SAE Report CTT21 V5.0 131021 Diagnostic test nameDateTest valueTest units h) Relevant Diagnostic Tests Yes (please give details) No (go to Section i) Continue on SAE supplemental page CTT21 A section h1i if more space is required Tick if using Page 4 of 4 Serious Adverse Event (SAE) Report d d m m y y y y Serious Adverse Event (SAE) Report Patient initials Patient ID Centre NumberTrial Number h1 ) Are there any test / laboratory findings to record? d d m m y y y y PLEASE FAX SAE REPORTS TO THE SPONSOR > within 24 hours of becoming aware of the SAE. THE SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax follow up information for SUSARs to the Sponsor as soon as possible. Page completed by_________________________________________Date form completed d d m m y y y y i) Causality and Expectedness i1 ) Is the SAE suspected to be related to the study treatments? Yes No (go to i2) Expectedness Expected Unexpected (= SUSAR) i2 ) If no, what is the most likely cause? Concomitant medications (Report on the CONCOMITANT MEDICATIONS SUPPLEMENTAL PAGE) Tick if using Disease name: Other illness (specify) Other (specify) THE SAE MUST BE REVIEWED AND THIS SECTION COMPLETED BY THE INVESTGATOR OR AN AUTHORISED, CLINICALLY QUALIFIED DELEGATE. Refer to the current approved SPC / IB appropriate to the trial Name _________________________________ Position _______________________________ Signature______________________________ Address ______________________________ ______________________________ Tel. No. ______________________________ Date ______________________________ Sponsor note: Section i to be updated with disease name and all trial drug names at the beginning of the trial. Trial treatment name Expected Unexpected (= SUSAR) Expected Unexpected (= SUSAR) i3) All suspected SUSARS must be reviewed by the CHIEF INVESTIGATOR. Chief Investigator signature to confirm formal review of this event as a SUSAR All suspected SUSARs should 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. DateSign