Appendix 10: GloMY Follow-Up Data Collection Form GloMY Follow-Up Data Collection Form Assessment Week (please tick) Assessment due at week 2, 4 then every 4 weeks for 6 months iilii 2 iilii 4 iilii 8 iilii 12 iilii 16 iilii 20 iilii 24 After 6 months assessment due every 12 weeks for at least 2yrs or until end of study iilii 36 iilii 48 iilii 60 iilii 72 iilii 84 iilii 96 iilii 108 iilii 120 iilii 132 iilii 144 iilii 156 iilii 168 iilii 180 iilii 192 iilii 204 Part A: Identifying Details Patient s Initials: iifii imi iilii Date of Assessment: idi idi / Mi imi / Yii iyii iyii iyii GloMY Trial.: ii I ii I ii I ii CRF completed by:.. (Please PRINT) Part B: Clinical Details Serum Creatinine:... (μmol/l) Serum Albumin:... (g/dl) egfr:... (ml/min) Protein Creatinine Ratio (PCR):...mg/mmol Blood Pressure:... /... (mmhg) Diabetes: Serum HbA1c:.. (%) Or Albumin Creatinine Ratio (ACR):.mg/mmol Weight:.. (kg) Or.. mmol/mol Is the patient in remission? Partial Remission? Date: Complete Remission? Date: Has the patient relapsed? If yes: Date of relapse: Has the patient reached ESRD? If yes: Date: For first 6 months follow-up only: Does the patient have resistant disease?: At 2 year assessment only: Has patient consented to having a repeat renal biopsy? Version.:. GloMY Follow-Up Form Page 1 of 5
Part C: Medication Myfortic dose (if randomised to Myfortic) Has the Myfortic dose changed? iilii iilii Prednisolone dose (if receiving steroids) Has the Prednisolone dose deviated from protocol? iilii iilii Has the patient required alternative immunosuppressive agent? iilii iilii... (total daily dose in mg) If, Date dose changed:. /. / If, Reason dose changed:...... (total daily dose in mg) If, Date dose changed:. /. / If, Reason dose changed:.. If, Immunosuppressive agent given?... Dose:... (total daily dose in mg) Date Started:.. /. /.. Anti-hypertensive therapy iil iil, If Diuretic iil iil β-blocker iil iil CA 2+ antagonist iil iil ACE-I antagonist iil iil A-II antagonist iil iil α-blocker iil iil Other, please specify iil iil Cholesterol lowering therapy iil iil, If Statin iil iil Fibrate iil iil Osteoporosis prophylaxis iil iil Infection prophylaxis iil iil GI prophylaxis iil iil GloMY Follow-Up Form Page 2 of 5
Part D: Complications and Events Has the patient had any of the following complications and/or events? Cardiac Date Details Myocardial infarction? New onset hypertension? Angina? Other cardiac? Blood and lymphatic system disorders Anaemia? Leucopenia? Thrombocytopenia? Other blood or lymphatic system disorder Gastrointestinal disorders Abdominal distension or pain? Constipation? Dyspepsia? Gastritis? Loose stools/diarrhoea? Nausea/Vomiting? GloMY Follow-Up Form Page 3 of 5
Ulceration? Other gastrointestinal disorder? Endocrine and metabolic disorders Date Details Has the patient developed steroid induced diabetes? Other endocrine or metabolic Disorder? Malignancies Cancer? Infections CMV? HSV? VZV? Other infection? Musculoskeletal and connective tissue disorders Avascular osteonecrosis Fractures? Osteoporosis? Other musculoskeletal and connective tissue disorder? Other Patient, or patient s partner, known to be pregnant? GloMY Follow-Up Form Page 4 of 5
Cataracts? Progressive multifocal leukoencephalopathy? Psychosis? Other? Serious Adverse Event (SAE) Reporting SAEs are any adverse events that: Results in death Are life threatening Require in-patient hospitalisation or prolongation of existing hospitalisation Result in persistent or significant disability or incapacity Result in a congenital anomaly or a birth defect If any of the above complications and/or events fulfil the criteria for a serious adverse event, then please complete the GloMY Serious Adverse Event (SAE) Form. For further details please refer to Section 6, Safety Assessment and Reporting, of the GloMY Protocol. Thank you for completing the GloMY Follow-up Data Collection Form. Please enter data online: GloMY Online Data Entry: https://www.trials.bham.ac.uk/glomy (24hrs) GloMY Study Office, The University of Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT. Tel: 0121 415 9130. Fax: 0121 415 9135 GloMY Trial Website: http://www.bctu.bham.ac.uk/glomy GloMY Trial Mailbox: GloMY-trial@contacts.bham.ac.uk GloMY Follow-Up Form Page 5 of 5