Target date to recruit patients agreed? Target range minimum. Target range maximum

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Bartholomew Greer
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1 No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date Total no of patients recruited at the agreed target date Total no of patients recruited study actually closed to recruitment at STH Reason for closure of trial 1 11/YH/ /H1307/ MiroCam endoscopy of the small bowel in patients with GI bleeding/iron deficiency Anaemia and findings at upper and lower GI endoscopy of unclear bleeding potential A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects with Hypereosinophilic Syndrome Agreed Agreed 01/01/ /10/2016 Recruitment Finished Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished 3 GTAC A Phase I study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes virus HSV1716 into the tumourbearing pleural cavity (intrapleural) in patients with inoperable malignant pleural mesothelioma Agreed Agreed 26/09/ /09/2016 Recruitment Finished 4 12/LO/ /LO/ A randomised, multicentre, open-label Phase III study to evaluate the efficacy and safety of Trastuzumab Emtansine versus Trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumour present pathologically in the breast or axillary lymph nodes following preoperative therapy. KATHERINE International non-randomized, single arm, long-term follow-up study of patients with uncontrolled hypertension Agreed 3 3 Agreed 30/04/ /01/2016 Recruitment Finished Agreed Agreed 31/01/ /09/2016 Recruitment Finished

2 Prospective, randomised, controlled investigation comparing the safety and performance of Surgical Haemostat 2g Applicator with 6 13/NW/0002 FLOSEAL Hemostatic Matrix as an adjunctive haemostat in cardiac surgery and thoracic aortic surgery. Agreed 17 Not Available / 17 Not Agreed /11/2016 Recruitment Finished 7 13/LO/ /EE/ CALM-NET: A Phase IV, Multicentre, Open label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients receiving Deep Subcutaneous Administrations of Somatuline (lanreotide) Autogel to treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET). Agreed 4 4 Agreed 22/07/ /07/2016 Recruitment Finished Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3) Agreed 3 5 Agreed 30/06/ /07/2016 Recruitment Finished 9 14/WM/ A multinational, randomised, double blind, placebo controlled trial to evaluate the effect of ticagrelor 90mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus. (THEMIS) Agreed Agreed 03/06/ /05/2016 Withdrawn By Sponsor 10 13/LO/ A Phase II Simon Two Stage Efficacy Study of Intracerebral CTX0E03 DP in Patients with Stable Paresis of the Arm Following an Ischaemic Stroke. Agreed 2 4 Agreed 05/08/ /08/2016 Recruitment Finished

3 11 14/WS/ A phase 3, multicentre, open label, randomised trial of nab-paclitaxel plus Gemcitabine versus Gemcitabine alone as adjuvant therapy in subjects with surgically resected pancreatic adenocarcinoma Agreed Agreed 30/06/ /03/2016 Recruitment Finished 12 14/LO/ /NW/ /LO/ Prospective, randomized, placebocontrolled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) Comparative testing of Transfix Vacuum blood collection tubes and Cytochex blood collection tubes for FDA 510 (k) submission Study : Albiglutide versus Placebo in Subjects with new- onset type 1 diabetes mellitus Agreed 2 2 Agreed 18/03/ /03/2016 Recruitment Finished Agreed Agreed 25/02/ /02/2016 Recruitment Finished Agreed 3 3 Agreed 26/05/ /05/2016 Recruitment Finished 15 13/LO/ A multicentre, randomized, doubleblind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction Agreed 6 6 Agreed 31/12/ /12/2016 Recruitment Finished 16 14/YH/ A Phase 2, Randomized, Placebo Controlled, Double Blind, Proof of concept Study of the Efficacy and Safety of PF in Subjects with Huntington s disease Agreed 4 10 Agreed 19/02/ /03/2016 Recruitment Finished

4 A phase iii, multicenter, randomized, double-masked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to patients with Geographic atrophy secondary to Agerelated macular degeneration Agreed 4 4 Agreed 30/09/ /09/2016 Recruitment 17 15/NE/ Finished 18 14/LO/ /SC/ A Phase 3, Randomized, Placebo- Controlled, Double-Blind Study of Oral MLN9708 Maintenance Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant - Millennium Agreed 3 3 Agreed 01/12/ /03/2016 Recruitment Finished A Multicenter, Randomized, Double Blind, Placebo controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus Agreed 5 5 Agreed 31/10/ /04/2016 Recruitment Finished 20 14/EM/ An open-label, multicenter study to provide patients with chronic heart failure and reduced ejection fraction access to LCZ696 following participation in PARADIGM-HF Agreed 2 2 Agreed 29/02/ /02/2016 Recruitment Finished A Randomized, Double-Blind, Placebo- Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction 21 15/LO/ Adenocarcinoma (RAINFALL) Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary 22 14/LO/ hypertension (CTEPH) Agreed 5 6 Agreed 31/12/ /11/2016 Recruitment Finished Agreed 1 1 Agreed 27/06/ /05/2016 Recruitment Finished

5 23 14/NW/0119 A 4 week phase 2a, multicentre, randomised, doubleblind, placebocontrolled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin Agreed 7 7 Agreed 15/03/ /03/2016 Recruitment Finished 24 15/LO/ Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration. Agreed 2 10 Agreed 09/09/ /09/2016 Recruitment Finished 25 15/LO/ An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS ) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC Agreed 9 9 Agreed 15/06/ /06/2016 Recruitment Finished 26 15/NW/ A Phase 3, Randomized, Doubleblind, Placebo-controlled, Parallel- Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of LX4211 as Adjunct Therapy in Adults Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy. Agreed 5 8 Agreed 30/04/ /04/2016 Recruitment Finished 27 15/WM/ A Randomized, Open-label, Phase 3 Study Assessing Safety and Efficacy in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Once-weekly Carfilzomib Compared to Twice-weekly Carfilzomib in Combination with Dexamethasone. Agreed 4 5 Agreed 30/08/ /08/2016 Recruitment Finished

6 A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in 28 14/LO/ Heterogeneous Emphysema 29 15/YH/ /LO/ Multi-center, Open-Label, Randomized, Two-Arm, Parallel- Group Study to Assess Efficacy and Safety of Envarsus Compared with Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in De Novo Kidney Transplant Patients An open-label, multi-center, nonrandomized Phase Ib study to investigate safety and tolerability of radium Ra 223 dichloride (BAY ) administered in combination with paclitaxel in cancer subjects with bone lesions. Agreed 5 10 Agreed 30/06/ /06/2016 Recruitment Finished Agreed 4 4 Agreed 30/08/ /07/2016 Recruitment Finished Agreed 2 4 Agreed 28/02/ /02/2016 Recruitment Finished 31 15/LO/ Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebocontrolled, cross-over, 3 period, multicentre study with open-label follow-up extension. Agreed 5 10 Agreed 31/07/ /07/2016 Recruitment Finished 32 15/LO/ /SC/ ExplorerTM3 A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects. Trial ID: NN A randomised, double-blind, placebocontrolled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcoma. Agreed 1 1 Agreed 31/03/ /10/2016 Recruitment Finished Agreed Agreed 30/06/ /05/2016 Withdrawn By Sponsor

7 A Randomized, double blind, placebocontrolled, phase 3 study to assess the efficacy and safety of KRN23 in adults with x-linked 34 15/SC/ hypophosphotaemia (XLH) /YH/ /EM/ /EM/ /NW/ /LO/ Agreed 6 6 Agreed 30/06/ /06/2016 Recruitment Finished Phase 3 Study Investigating the Efficacy, Safety and Tolerability of Dupilumab Monotherapy Administered to Adult Patients With Atopic Dermatitis (AD) Who Are Not Adequately Controlled With or Are Intolerant to Oral Cyclosporine or When This Treatment is Not Medically Advisable. Agreed 5 5 Agreed 31/10/ /10/2016 Recruitment Finished A Multi Center, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington s Disease (Open PRIDE HD) Agreed 0 3 Agreed 30/07/ /02/2016 Recruitment Finished The BAHA Attract System with Cochlear BAHA 5 SuperPower. Agreed 3 5 Agreed 30/07/ /09/2016 Recruitment Finished A Prospective Observational Trial to Evaluate the Correlation of T-SPOT Response to CMV Infection and T cellmediated Acute Graft Rejection. The PROTECT Study. Agreed Agreed 31/01/ /09/2016 Recruitment Finished A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Bladder Cancer. Agreed 2 2 Agreed 31/12/ /12/2016 Recruitment Finished

8 40 16/SC/ A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma. Agreed 2 2 Agreed 30/04/ /12/2016 Recruitment Finished

Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.

Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished. No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target