Targeted Adverse Event (ADV)

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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

4 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)

5 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

6 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:

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

8 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Epstein Barr Virus (EB1) Web Version: 1.0; 1.1; Inclusion criteria: Asymptomatic EBV viremia. Definition of Asymptomac EBV viremia: Patient has detected EBV viral load without any symptoms and signs such as fever, weight loss, rash, lymphadneopathy, and hepatosplenomegaly Exclusion criteria: Diagnosed PTLD prior to or at time of first detected EBV load TRANSPLANTS SHOULD BE AFTER 01/01/2005 Eligibility 1. Has the viral load been measured by real-time PCR? 1- No 2- Yes (IF "NO" DO NOT COMPLETE FORM) 2. Date of first detected EBV: (mm/dd/yyyy) Viral Copy Numbers: (xxxxxxxxxx.x) Viral Copy Units: If "Other", Specify: Type of Sample: Normal Detection Limit: (xxxxxxxxxx.x) Serum Creatinine: (xx.xx) mg/dl Height: (xxx.x) cm Weight: (xxx.x) kg Pre-Transplant/Transplant Factors 3. Pre-transplant EBV serology: EBV Donor Serology: EBV Recipient Serology: CMV Donor Serology: CMV Recipient Serology: 4. Induction Antibody Therapy at Transplant:

9 If "O the r", Sp eci fy: Average Daily Dose: (xxxxxxx.xx) mg/kg Total Dose Administered: (xxxxxxx.xx) mg/kg Number of Days: (xxx) 5. Symptomatic CMV infection post-transplant? 1- No 2- Yes If "Yes", date of CMV infection? (mm/dd/yyyy) 6. Asymptomatic CMV viremia post-transplant? 1- No 2- Yes If "Yes", date of CMV viremia? (mm/dd/yyyy) 7. Initial anti-viral agent prophylactic use? 1- No 2- Yes If "Yes", what Agent? 1-IVIG 2-VALGANCICLOVIR 9-Other, If other specify If Other, what agent? Dose: (xxxxxxx.xx) mg (If 2-VALGANCICLOVIR put daily dose) Duration: Start Date: (mm/dd/yyyy) Stop Date: (mm/dd/yyyy) Intervention 8. Reduction of Immunosuppression? 1- No 2- Yes Type(s) of reduction: Calcineurin dose reduction reduced by: (xxx) % Calcineurin discontinuation? 1- No 2- Yes DNA synthesis inhibitor dose reduction: (xxx) % DNA synthesis inhibitor discontinuation? 1- No 2- Yes Steroid dose reduction: (xxx) % Steroid discontinuation? 1- No 2- Yes 9. Anti-CD20 antibody use? 1- No 2- Yes Number of Anti-CD20 doses: (xxx) Total dose administered: (xxxxxxx.xx) mg 10. Anti-viral therapy started? 1- No 2- Yes If "Yes", what agent used? 1-IVIG 2-VALGANCICLOVIR 9-Other, If other specify If Other, what agent? Dose: (xxxxxxx.xx) mg (If 2-VALGANCICLOVIR put daily dose) Duration: Start Date: (mm/dd/yyyy) Stop Date: (mm/dd/yyyy) Outcome 11. Did patient develop an Acute rejection? 1- No 2- Yes 12. Did patient develop a PTLD? 1- No 2- Yes If "Yes", PTLD Date : (mm/dd/yyyy) 13. Date immunosupression medication increased: (mm/dd/yyyy) 14. Did patient develop Graft Loss? 1- No 2- Yes If "Yes", date of Graft Loss: (mm/dd/yyyy) COMMENT:

10 Additional Selection Options for EB1 Induction Antibody Therapy at Transplant: None

11 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: EB Followup (EB2) Web Version: 1.0; 1.1; Inclusion criteria: Asymptomatic EBV viremia. Definition of Asymptomac EBV viremia: Patient has detected EBV viral load without any symptoms and signs such as fever, weight loss, rash, lymphadneopathy, and hepatosplenomegaly Exclusion criteria: Diagnosed PTLD prior to or at time of first detected EBV load Sebsequent EBV Viral Loads: Seq # DATE (mm/dd/yyyy) VIRAL LOAD (xxxxxxxxxx.x) SAMPLE TYPE VIRAL COPY UNITS NORMAL DETECTION LIMIT ( xxxxxxxxxx.x) SERUM CREATININE ( xx.xx)

12

13

14 COMMENT:

15 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: T RANSA (ENR) Web Version: 1.0; 1.0; Enter the initial Date of Transplant to enroll participant into the T ransplant Re gistry: 2. Enter the initial Date of Transplant to enroll participant into the T ransplant Re gistry: (mm/dd/yyyy) (mm/dd/yyyy)

16 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Graft Failure (GRA) Web Version: 1.0; 1.3; Transplant date: 1. Graft failure date: (mm/dd/yyyy) 2. Date of graft failure was determined by: If other, specify: Submit a Dialysis Initiation form for patients returning to maintenance dialysis. Submit a Transplant Report form for patients who were retransplanted. 3. Cause of graft failure: If other, specify reason for graft failure: 4. Tissue confirmation of cause: 5. Was failure to comply with maintenance therapy considered to be a contributing cause? 1-No 2-Yes 6. Comments:

17 Additional Selection Options for GRA Cause of graft failure: Acute rejection Chronic rejection Recurrence of original kidney disease Renal artery stenosis Bacterial/viral infection required discontinuation of immunosuppression Cyclosporine toxicity De novo kidney disease Patient discontinued medications Malignancy Death with function Administrative closure Other, specify

18 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:

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

20 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

21 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:

22 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Date of Treatment: Acute Rejection (REJ) Web Version: 1.0; 1.3; Allograft biopsy performed? 2. Weight: (xxx.x) kg IMMUNOSUPPRESSIVE TREATMENT-Supplemental to Maintenance Include only doses over and above specified maintenance medications. Medication Initial Daily Dose (mg/d) Duration in days of anti-rejection therapy Formulation or Mode Prednisone Methylprednisolone-oral Methylprednisolone-IV Cyclosporine Tacrolimus Azathioprine Mycophenolate mofetil ATG/ALG Sirolimus Monoclonal antibody 3. Calcineurin trough level: (xxxx.x)

23 a. Calcineurin assay: 4. Sirolimus trough level: (xxxx.x) a. Sirolimus assay: 5. Were other non-maintenance immunosuppressive treatments applied? 1-No 2-Yes Specify other immunosuppressive medication: 6. Was patient receiving growth hormone at the time of acute rejection? 1-No 2-Yes 7. Outcome of this acute rejection: Submit a Graft Failure or Death form if outcome resulted in graft failure or death. Check to unlock and change unit of measurement: 8. CU SI Uni ts Serum creatinine: (xx.x) (xxxx.x) mg/d L µmol/l 9. Was dialysis used during anti-rejection therapy? 1-No 2-Yes 10. Comments:

24 Additional Selection Options for REJ Mono. AB formulation 8-8-Other 9-9-Unknown Calcineurin assay: 6-6-EMIT 7-7-ELISA 8-8-IMx 9-9-Other

25 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Visit Number: Transplantation Status (STA) Web Version: 1.0; 2.0; Transplant date: 1. Graft status: 2. Height: (xxx.x) cm 3. Date height obtained: (mm/dd/yyyy) 4. Weight: (xxx.x) kg 5. Blood pressure: / (xxx) mmhg 6. Tanner stage: Pubic hair: Breast: Testicular size: Check to unlock and change unit of measurement. 7. CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l Hemoglobin: (xx.xx) (xxx) mg/dl µmol/l 8. Creatinine date: (mm/dd/yyyy) 9. Number of acute rejection episodes since last report: (x) Document each acute rejection episode on an Acute Rejection form. 10. Number of episodes of acute cyclosporine nephrotoxicity: (x) 11. IMMUNOSUPPRESSIVE TREATMENT (Maintenance Only) Prednisone Medication Daily Maintenance Dose as of Report Date Alternate Day Schedule Formulation Cyclosporine Tacrolimus Azathioprine Mycophenolate mofetil

26 Sirolimus 12. Calcineurin trough level: (xxxx.x) Assay: 13. Sirolimus trough level: (xxxx.x) Assay: 14. Were other immunosuppressive agents given? 1-No 2-Yes If Yes, specify: 15. CONCOMITANT DRUG THERAPY Antico nvu lsa nt: 1-No 2-Yes Anti-hypertensive: 1-No 2-Yes Antibiotics: 1-No 2-Yes Growth hormone: 1-No 2-Yes Erythropoietin: 1-No 2-Yes 16. Total number of days hospitalized this period: (xxx) Was patient hospitalized for the following: Bacterial infection: 1-No 2-Yes Viral infection: 1-No 2-Yes Rejection: 1-No 2-Yes Fungal/protozoal infection: 1-No 2-Yes Hypertension: 1-No 2-Yes 17. Was a malignancy diagnosed during this report period? 1-No 2-Yes If Yes, su bmit a Malignancy form. 18. Has the patient had an echocardiogram performed since the last report? 1-No 2-Yes If yes: a. Absolute LV mass: (xxx.xx) (grams) b. LVM Index units: 1-gm/m 2 2-gm/m 2.7 c. LVM Index: (xxx.xx) EDUCATION INFORMATION 19. Has the patient completed high school education: 1-No 2-Yes If no, indicate one of the following: 20. Is the patient participating in a formal adult transition program? 1-No 2-Yes Comments:

27 Additional Selection Options for STA Tanner stage public hair 6-6-Unknown Tanner stage testicular 6-6-Unknown Assay: 6-6-EMIT 7-7-ELISA 8-8-IMx 9-9-Other If no, indicate one of the following: 6-6-Not of school age

28 North American Pediatric Renal Trials Collaborative Studies Production Release 14.0 [$sitecode] User: Registry Sequence: Transplantation Report (TRA) Web Version: 1.0; 2.0; Transplant date: 1. Weight: (xxx.x) kg 2. Height: (xxx.x) cm 3. Was patient on maintenance dialysis immediately prior to this transplant? Duration of maintenance dialysis: (xx) Years + (xx) Months 4. Has patient had a SPLENECTOMY? 1-No 2-Yes 5. Has patient had all NATIVE renal tissue removed? 1-No 2-Yes 6. Has patient had all PRIOR transplants removed? 1-No 2-Yes 3-Not applicable 7. Donor source: 8. Donor age: (xx) 9. Donor sex: 1-Male 2-Female 10. HISTOCOMPATIBILITY DATA OF DONOR HLA-A: A (xx) A (xx) HLA-B: B (xx) B (xx) HLA-DR: DR (xx) DR (xx) ABO: 1-A 2-B 3-O 4-AB IF DONOR SOURCE IS CADAVER, ANSWER THE FOLLOWING: 11. Method of allograft preservation a. Machine perfusion b. Iced electrolyte c. T otal cold time (xxx) Hours + (xx) Minutes PRE-TRANSPLANT BLOOD TRANSFUSION DATA FOR THIS TRANSPLANT 12. Was donor specific transfusion performed?

29 13. Specify life-time T OTAL NUMBER of RANDOM TRANSFUSIONS given: 14. Was immunosuppressive therapy used in the preoperative period (i.e., one week to 24 hours pretransplant)? 1-No 2-Yes POST-TRANSPLANTATION (30 DAYS) MAINTENANCE MEDICATION DATA Prednisone Medication Day Post Op Initiated Dose # of Days Formulation Day 30 Dose Methylprednisolone Cyclosporine Tacrolimus Azathioprine Mycophenolate mofetil ATG/ALG Sirolimus Monoclonal Ab 15. Were other immunosuppressive agents given? 1-No 2-Yes If Yes, specify: 16. Days of hospitalization during post transplant month: (xx) maximum of 31 days 17. Consecutive hospitalization days from transplantation to discharge: (xxx) CONCOMITANT DRUG THERAPY 18. Antico nvu lsa nt: 1-No 2-Yes 19. Anti-hypertensive: 1-No 2-Yes 20. Antibiotics: 1-No 2-Yes (excluding perioperative) Check to unlock and change unit of measurement: CU SI Un its 21. Day 30 Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l 22. Day 30 Calcineurin blood level (Cyclosporine or Tacrolimus): (xxxx.x) Assay: 23. Day 30 Sirolimus blood level: (xxxx.x) POST TRANSPLANT DIALYSIS USE 24. Week 1: 1-No 2-Yes Assay:

30 25. Week 2: 1-No 2-Yes 26. Week 3-4: 1-No 2-Yes 27. Was patient treated for acute rejection during the first 30 days after transplantation? If Yes, submit ACUTE REJECTION form. 28. Did graft failure (permanent return to dialysis) occur during the first 30 days after transplantation? If Yes, submit GRAFT FAILURE form. 1-No 1-No 2-Yes 2-Yes Comments:

31 Additional Selection Options for TRA MaB formulation 8-8-Other 9-9-Unknown Assay: 6-6-EMIT 7-7-ELISA 8-8-IMx 9-9-Other

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