Targeted Adverse Event (ADV)

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Samson Cummings
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North American Pediatric Renal Trials Collaborative Studies Production Release 14.

If avascular necrosis or slipped capital femoral epiphyses, record the following: Onset: 1-Initial 2-Recurring X-ray confirmation: 1-No 2-Yes Bone scan confirmation: 1-No 2-Yes 3.

1-No 2-Yes 4. If Serious adverse event, please specify: 5. If Other adverse event, please specify: 6. Intensity: 7. Outcome: 8. Treatment required?

1 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Adverse Event: Adverse Event Date: Targeted Adverse Event (ADV) Web Version: 1.0; 2.0; If malignancy, please specify diagnosis: 2. If avascular necrosis or slipped capital femoral epiphyses, record the following: Onset: 1-Initial 2-Recurring X-ray confirmation: 1-No 2-Yes Bone scan confirmation: 1-No 2-Yes 3. If intracranial hypertension, record the following: Opening CSF pressure: (xxx) mmh2o Headache: 1-No 2-Yes Papilledema: 1-No 2-Yes Nausea & vomiting: 1-No 2-Yes Visual changes: 1-No 2-Yes 4. If Serious adverse event, please specify: 5. If Other adverse event, please specify: 6. Intensity: 7. Outcome: 8. Treatment required? 1-No 2-Yes Hospitalization: 1-No 2-Yes Medication: 1-No 2-Yes Surgery: 1-No 2-Yes Other treatment: 1-No 2-Yes If Other treatment, specify: 9. Was patient receiving growth hormone at the time of adverse event? 1-No 2-Yes If receiving growth hormone, record the following: a. Type: b. Route c. Frequency: d. Dose: (xx.xx) mg/d ose

2 e. Dosage of growth hormone was: f. If dose changed, provide date: (mm/dd/yyyy) Did the adverse event abate? 1-No 2-Yes If Yes, record date: (mm/dd/yyyy) g. Was growth hormone reintroduced? 1-No 2-Yes If Yes, did the adverse event recur? 1-No 2-Yes If Yes, when? (mm/dd/yyyy) 10. Relationship to growth hormone: 11. Comments:

3 Additional Selection Options for ADV Adverse Event (key field): 1-1-Malignancy 2-2-Avascular necrosis 3-3-Slipped capital femoral epiphyses 4-4-Intracranial hypertension 5-5-Other serious adverse event 6-6-Other adverse event Frequency: 6-6-Every other week 7-7-Monthly 9-9-Other

North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Chronic Kidney Disease Termination (CRI) Web Version: 1.0; 1.4; 06-20-13 1.

4 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Chronic Kidney Disease Termination (CRI) Web Version: 1.0; 1.4; Date of termination: (mm/dd/yyyy) 2. Patient height at termination: (xxx.x) cm Check to unlock and change unit of measurements: 3. CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l 4. Reason for termination: If Other, specify: 5. Comments:

5 Additional Selection Options for CRI Reason for termination: 9-9-Other

Weight: (xxx.x) kg 3. Height: (xxx.x) cm 4. Tanner Stage: Pubic hair: Breast: Testicular size: 5. Are anthropometric measures available? 1-No 2-Yes If Yes, indicate: a.

CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/d L µmol/l Hematocrit: (xx.x) (.xxx) % VF BUN: (xxx) (xx.x) mg/dl mmol/l CO 2: (xx) (xx) meq/l mmol/l Inorganic phosphorus: (xx.

6 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Visit Number: Chronic Kidney Disease Status (CRS) Web Version: 1.0; 1.6; Date of examination: (mm/dd/yyyy) PHYSICAL DATA 2. Weight: (xxx.x) kg 3. Height: (xxx.x) cm 4. Tanner Stage: Pubic hair: Breast: Testicular size: 5. Are anthropometric measures available? 1-No 2-Yes If Yes, indicate: a. Mid arm circumference: (xx.x) cm b. Tricep skin fold thickness: (xx.x) mm 6. Blood pressure: (xxx) / (xxx) mm Hg Check to unlock and change units of measurement: 7. CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/d L µmol/l Hematocrit: (xx.x) (.xxx) % VF BUN: (xxx) (xx.x) mg/dl mmol/l CO 2: (xx) (xx) meq/l mmol/l Inorganic phosphorus: (xx.x) (x.xx) mg/dl mmol/l Calcium: (xx.x) (x.xx) mg/dl mmol/l Albumin: (xx.x) (xxx) g/dl g/l Alkaline phophatase: Hemoglobin: (xxxx) (xx.xx) IU/mL µkat/l (xx.xx) (xxxx.xx) g/dl g/l 8. Most recent parathyroid hormone: Medication Data 9. Is the patient receiving erythropoietin? 1-No 2-Yes a. Type:

b. Route: c. Frequency: d. Units/dose: 10. Is the patient receiving human growth hormone? 1-No 2-Yes a. Type: b. Frequency: c. Dose: 11. Concomitant Drug Therapy a. Antico nvu lsa nt: 1-No 2-Yes b.

7 b. Route: c. Frequency: d. Units/dose: 10. Is the patient receiving human growth hormone? 1-No 2-Yes a. Type: b. Frequency: c. Dose: 11. Concomitant Drug Therapy a. Antico nvu lsa nt: 1-No 2-Yes b. Antihypertensives: 1-No 2-Yes If Yes, number of drugs: (x) c. Prophylactic antibiotics: 1-No 2-Yes d. Sevelamer hydrochloride: 1-No 2-Yes e. Alkali therapy: 1-No 2-Yes f. Immunosuppressives: 1-No 2-Yes 1. Prednisone: 2. Other immunosuppressives: Dose: (xxx.x) mg/day g. Lipid lowering agents: 1-No 2-Yes h. 1,25-dihydroxy Vitamin D (oral): 1-No 2-Yes i. Other Vitamin D compounds: 1-No 2-Yes j. Iron (oral): 1-No 2-Yes k. Iron (IV): 1-No 2-Yes l. Parenteral nutrition: 1-No 2-Yes m. Supplemental enteral nutrition: 1-No 2-Yes If Yes, specify: n. Calcium carbonate: 1-No 2-Yes o. Calcium acetate: 1-No 2-Yes p. Other calcium supplements: 1-No 2-Yes Events Data If this is the initial CRI Status form, has patient ever had the event? If this is not the initial CRI Status form, has the patient had the event since the last report? 12. Urologic surgery: 1-No 2-Yes 9-Unknown 13. Orthopedic surgery: 1-No 2-Yes 9-Unknown

Blood transfusions: 1-No 2-Yes 9-Unknown If Yes, number of episodes: (x) Education Data 20. Has patient completed high school education?

8 14. Urinary tract infection: 1-No 2-Yes 9-Unknown 15. Hip x-ray: 1-No 2-Yes 9-Unknown a. If Yes, left hip: b. Right hip: 16. Seizures: 1-No 2-Yes 9-Unknown 17. Renal biopsy: 1-No 2-Yes 9-Unknown 18. Fluid and electrolyte abnormalities: 1-No 2-Yes 9-Unknown 19. Blood transfusions: 1-No 2-Yes 9-Unknown If Yes, number of episodes: (x) Education Data 20. Has patient completed high school education? 1-No 2-Yes If No: Hospitalization Data Omit for initial CRI Status Form 21. Total days hospitalized since last report: (xxx) 22. Number of hospitalizations since last report: (xx) Reasons for hospitalization: a. Infection: 1-No 2-Yes b. Hypertension: 1-No 2-Yes c. Other cardiovascular: 1-No 2-Yes 23. Comments:

9 Additional Selection Options for CRS Pubic hair: 6-6-Unknown Testicular size: 6-6-Unknown Frequency: 6-6-Every other week 7-7-Monthly 9-9-Other Other immunosuppressives: 6-6-Tacrolimus 9-9-Other If No: 6-6-Not of school age

North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registration (DEM) Web Version: 1.0; 1.

Gender: 1-Male 2-Female 5. Primary renal diagnosis: If Other, specify diagnosis: 6.

Insurance Information: Does patient have Medicaid? 1-No 2-Yes 9-Unknown Does patient have supplemental private insurance?

Has patient ever received maintenance dialysis? If Yes, specify date of first maintenance dialysis: (xx) Month/ (xxxx) Year 12.

10 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registration (DEM) Web Version: 1.0; 1.4; Does your site participate in the NAPRT CS Registries? 1- No 2- Yes 2. Date of birth: (mm/dd/yyyy) 3. Race/ethnicity: 4. Gender: 1-Male 2-Female 5. Primary renal diagnosis: If Other, specify diagnosis: 6. Biopsy or nephrectomy confirmation of diagnosis: 1-No 2-Yes 9-Unknown 7. Maternal Paternal Education Score: 8. Insurance Information: Does patient have Medicaid? 1-No 2-Yes 9-Unknown Does patient have supplemental private insurance? 1-No 2-Yes 9-Unknown 9. Has patient been transplanted prior to registration: 1-No 2-Yes 10. Total number of prior transplants: (x) 11. Has patient ever received maintenance dialysis? If Yes, specify date of first maintenance dialysis: (xx) Month/ (xxxx) Year 12. ABO (record for Transplant and Dialysis participants): 1-A 2-B 3-O 4-AB 13. Histocompatibility data of recipient Record for transplant participants: HLA-A A (xx) A (xx) HLA-B B (xx) B (xx) If assay performed but an allele was not determined, enter '99' HLA-DR DR (xx) DR (xx)

11 Additional Selection Options for DEM Primary renal diagnosis: Familial nephritis - Alport's Syndrome Cystinosis Oxalosis Congenital nephrotic syndrome Focal segmental glomerulosclerosis Membranoproliferative glomerulonephritis - Type I Membranoproliferative glomerulonephritis - Type II Membranous nephropathy Idiopathic crescentic glomerulonephritis Chronic glomerulonephritis Pyelonephritis/interstitial nephritis Reflux nephropathy SID w/sle nephritis SID w/henoch-schonlein purpura nephritis SID w/berger's nephritis (IgA) SID w/wegener's granulomatosis SID w/other Wilms' tumor Renal infarct Diabetic glomerulonephritis Sickle cell nephropathy Hemolytic uremic syndrome Drash syndrome Unknown Other, specify Education Score Maternal 5-5-Some college/ business/ vocational 6-6-College degree 7-7-Graduate work 9-9-Unknown

12 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Patient Death (DTH) Web Version: 1.0; 1.1; Date of death: (mm/dd/yyyy) 2. Cause of death: If other, specify cause of death: 3. Graft status at death: 4. Comments:

13 Additional Selection Options for DTH Cause of death: Hemorrhage Recurrence of original renal disease Dialysis-related complications Other, specify Unknown

14 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: CRIPRA (ENR) Web Version: 1.0; 1.4; Enter the date of CKD Initiation to register this participant into the CKD Re gistry: 2. Enter the date of CKD Initiation to register this participant into the CKD Re gistry: (mm/dd/yyyy) (mm/dd/yyyy) 3. Patient weight at enrollment: (xxx.x) kg 4. Patient height at enrollment: (xxx.x) cm Check to unlock and change unit of measurement: 5. CU SI Units Serum Creatinine: (xx.x) (xxxx.x) mg/dl µmol/l To qualify for the CKD Registry patients must have a creatinine clearance of less than or equal to 75 ml/ min /173 m 3, based on the Schwartz formula: Creatinine Clearance: Patients who have received maintenance dialysis or who have been transplanted do not qualify for the CKD Registry.

15 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Lost to Follow Up (LTF) Web Version: 1.0; 1.3; Date lost to follow up: (mm/dd/yyyy) 2. Reason for loss: If Other, specify: 3. Graft status at loss: 4. Comments:

16 Additional Selection Options for LTF Reason for loss: 8-8-Administrative Closure 9-9-Other

North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Malignancy date: Malignancy Form (MAL) Web Version: 1.0; 2.0; 06-20-13 1. Type of malignancy: 2.

17 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Malignancy date: Malignancy Form (MAL) Web Version: 1.0; 2.0; Type of malignancy: 2. Specify malignancy: 3. Is this malignancy a PTLD? 1-No 2-Yes If this malignancy is a "PTLD", please complete the remainder of form. 4. Height at diagnosis of PTLD: (xxx.x) cms 5. Weight at diagnosis of PTLD: (xxx.x) kg 6. Type of PTLD: 7. Clonality: 8. Cell type: 1-T-Cell 2-B-Cell 9-Other, specify a. If "Other", specify: b. PT LD pathology Epstein-Barr virus stain (EBER or LMP): 1-Positive 2-Negative 9-Unknown/Not done c. PT LD pathology CD 20 stain: 1-Positive 2-Negative 9-Unknown/Not done 9. Location of PT LD: a. Allograft 1-No 2-Yes b. Lymph node 1-No 2-Yes c. Central nervous system 1-No 2-Yes d. Other 1-No 2-Yes 1. If "Other", specify 10. Pre-transplant EBV serology: a. Donor: 1-Positive 2-Negative 9-Unknown/Not done b. Recipient: 1-Positive 2-Negative 9-Unknown/Not done 11. Serum creatinine at diagnosis of PTLD: (xx.x) mg/dl OR (xxxx.x) µmol/l 12. Last prior serum creatinine value (3 months before diagnosis): (xx.x) mg/dl OR (xxxx.x) µmol/l 13. Date of last prior serum creatinine value: (mm/dd/yyyy) Intervention Data 14. Reduction of Immunosuppression: 1-No 2-Yes a. If "Yes", specify type(s) of reduction: 15. Anti-CD20 antibody use: 1-No 2-Yes a. If "Yes", number of doses: (xxx) b. Total dose administered: (xxxx.xx) mg 16. Alpha interferon use: 1-No 2-Yes a. If "Yes", number of doses: (xxx) b. Total dose administered: (xxxx.xx) mg

18 17. Chemotherapy used: 1-No 2-Yes a. If "Yes", regimen used: b. If "Yes", number of cycles: (xxx) c. If "Yes", duration of therapy in months: (xxx) Months 18. Anti-viral therapy use: 1-No 2-Yes a. If "Yes", agent used: b. Dose administered: (xxxx.xx) mg/day c. Duration of therapy: (xxx) Months 19. Surgical reduction of mass: 1-No 2-Yes a. If "Yes", allograft nephrectomy: 1-No 2-Yes 20. Concomitant rejection treatment: 1-No 2-Yes a. If "Yes", agent used: Outcome Data 21. Viral load by PCR: 1-No 2-Yes a. If "Yes", value at diagnosis: (xxxxxxxxxx.x) Units b. If "Yes", value at 1 month after diagnosis: (xxxxxxxxxx.x) c. If "Yes", value at time of increase in immunosuppression: (xxxxxxxxxx.x) 22. Serum creatinine after PTLD treatment: (xx.x) mg/dl OR (xxxx.x) µmol/l 23. Date of serum creatinine after treatment: (mm/dd/yyyy) 24. Graft loss: 1-No 2-Yes a. If "Yes", date: (mm/dd/yyyy) 25. Date immunosuppression increased again: (mm/dd/yyyy) 26. Immunosuppression after PTLD resolution: 1-No 2-Yes Agent Dose Prednisone (xx.x) Cyclosporine (xxx.x) Tacrolimus Sirolimus (xxx.x) (xx.x) Mycophenolate mofetil (xxxx.x) Azathioprine (xxx.x) 27. Retransplant after PT LD: 1-No 2-Yes a. If "Yes", date of retransplant: (mm/dd/yyyy) 28. Recurrence of PTLD in retransplant: 1-No 2-Yes a. If "Yes", date of recurrence: (mm/dd/yyyy) Comments:

Protocol: CRI Registry (CRIPR) Targeted Adverse Event(ADV)

Protocol: CRI Registry (CRIPR) Targeted Adverse Event(ADV) Page 1 of 19 Targeted Adverse Event(ADV) Version: 1.1; 02-03 Adverse Event: 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event