Targeted Adverse Event (ADV)

Transcription

1 Page 1 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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: 1-Mild 2-Moderate 3-Severe 4-Life-threatening 1-Severe or permanent disability 2-Death 3-Neither 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? If receiving growth hormone, record the following: a. Type: b. Route 1-No 2-Yes 1-Nutropin 2-Protropin 3-Humatrope 4-Nutropin Depot 1-Subcutaneous 2-Intraperitoneal c. Frequency:

2 Page 2 of 35 1-Daily 2-Every other day 3-Three times/week 4-Six times/week 5-Weekly *Additional Options Listed Below d. Dose: (xx.xx) mg/dose e. Dosage of growth hormone was: 1-Unchanged 2-Reduced 3-Held 4-Discontinued 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: 1-Not related- never received 2-Not related 3-Possible 4-Probable

3 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for ADV Page 3 of 35 Adverse Event (key field): 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event 6-Other adverse event Frequency: 6-Every other week 7-Monthly

4 Page 4 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$sitecode] User: Registration (DEM) Web Version: 1.0; 1.4; Does your site participate in the NAPRTCS Registries? 1- No 2- Yes 2. Date of birth: (mm/dd/yyyy) 3. Race/ethnicity: 1-White 2-Black 3-Hispanic 4. Gender: 1-Male 2-Female 5. Primary renal diagnosis: If Other, specify diagnosis: 01-Aplastic/hypoplastic/dysplastic kidneys 02-Obstructive uropathy 03-Syndrome of agenesis of abdominal musculature (Prune Belly) 04-Polycystic kidney disease 05-Medullary cystic disease/juvenile nephronophthisis *Additional Options Listed Below 6. Biopsy or nephrectomy confirmation of diagnosis: 1-No 2-Yes 9-Unknown 7. Maternal Paternal Education Score: 8. Insurance Information: 0-No formal education 1-Grade 6 or less 2-Grades Grades 10 or more without diploma 4-Grade 12 (High school graduate) *Additional Options Listed Below 0-No formal education 1-Grade 6 or less 2-Grades Grades 10 or more without diploma 4-Grade 12 (High school graduate) *Additional Options Listed Below 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? 1-No 2-Yes, hemodialysis 3-Yes, peritoneal dialysis 4-Yes, both 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 HLA-B HLA-DR A (xx) A (xx) B (xx) B (xx) If assay performed but an allele was not determined, enter '99'

5 Page 5 of 35 DR (xx) DR (xx)

6 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for DEM Page 6 of 35 Primary renal diagnosis: 06-Familial nephritis - Alport's Syndrome 07-Cystinosis 08-Oxalosis 09-Congenital nephrotic syndrome 10-Focal segmental glomerulosclerosis 11-Membranoproliferative glomerulonephritis - Type I 12-Membranoproliferative glomerulonephritis - Type II 13-Membranous nephropathy 14-Idiopathic crescentic glomerulonephritis 15-Chronic glomerulonephritis 16-Pyelonephritis/interstitial nephritis 17-Reflux nephropathy 18-SID w/sle nephritis 19-SID w/henoch-schonlein purpura nephritis 20-SID w/berger's nephritis (IgA) 21-SID w/wegener's granulomatosis 22-SID w/other 23-Wilms' tumor 24-Renal infarct 25-Diabetic glomerulonephritis 26-Sickle cell nephropathy 27-Hemolytic uremic syndrome 28-Drash syndrome 30-Unknown 9, specify Education Score Maternal 5-Some college/ business/ vocational 6-College degree 7-Graduate work 9-Unknown

7 Page 7 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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: 01-Infection, viral 02-Infection, bacterial 03-Infection, not specified 04-Cancer/malignancy 05-Cardiopulmonary *Additional Options Listed Below 1-Functioning 2-Non-functioning 3-Not applicable

8 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for DTH Page 8 of 35 Cause of death: 06-Hemorrhage 07-Recurrence of original renal disease 08-Dialysis-related complications 0, specify 10-Unknown

9 Page 9 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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: Viral Copy Units: If "Other", Specify: Type of Sample: Normal Detection Limit: Serum Creatinine: Height: Weight: 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: (xx.xx) mg/dl (xxx.x) cm (xxx.x) kg 1-Donor Positive 2-Donor Negative 3-Donor Unknown 1-Recipient Positive 2-Recipient Negative 3-Recipient Unknown 1-Donor Positive 2-Donor Negative 3-Donor Unknown 1-Recipient Positive 2-Recipient Negative 3-Recipient Unknown (xxxxxxxxxx.x) (xxxxxxxxxx.x)

10 Page 10 of Thymoglobulin 2-Anti -ILR2 3-Anti -CD52 4-Polyclonal Antibodies, If other specify *Additional Options Listed Below If "Other", Specify: Average Daily Dose: Total Dose Administered: (xxxxxxx.xx) mg/kg (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, 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, 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)

11 Page 11 of 35 COMMENT:

12 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for EB1 Page 12 of 35 Induction Antibody Therapy at Transplant: 99-None

13 Page 13 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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)

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17 Page 17 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$sitecode] User: TRANSA (ENR) Web Version: 1.0; 1.0; Enter the initial Date of Transplant to enroll participant into the Transplant Registry: 2. Enter the initial Date of Transplant to enroll participant into the Transplant Registry: (mm/dd/yyyy) (mm/dd/yyyy)

18 Page 18 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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: 1-Patient returning to regular course of maintenance dialysis 2-Patient receiving an additional transplant, 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: 01-Primary non-function 02-Vascular thrombosis 03-Other technical 04-Hyperacute rejection (< 24 hours after transplant) 05-Accelerated acute rejection (2-7 days after transplant) *Additional Options Listed Below 4. Tissue confirmation of cause: 5. Was failure to comply with maintenance therapy considered to be a contributing cause? 1-No 2-Yes 9-Unknown 1-No 2-Yes 6. Comments:

19 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for GRA Page 19 of 35 Cause of graft failure: 06-Acute rejection 07-Chronic rejection 08-Recurrence of original kidney disease 09-Renal artery stenosis 10-Bacterial/viral infection required discontinuation of immunosuppression 11-Cyclosporine toxicity 12-De novo kidney disease 13-Patient discontinued medications 14-Malignancy 15-Death with function 98-Administrative closure 9, specify

20 Page 20 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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: 1-Patient moved to nonparticpating center 2-Unable to locate patient 3-Patient refused further follow up 4-Parent refused further follow up 5-Patient transferred to adult program *Additional Options Listed Below 1-Functioning 2-Non-functioning 3-Not applicable

21 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for LTF Page 21 of 35 Reason for loss: 8-Administrative Closure

22 Page 22 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$sitecode] User: Malignancy date: Malignancy Form (MAL) Web Version: 1.0; 2.0; Type of malignancy: 2. Specify malignancy: 1-Hematologic/Lymphoietic 2-Solid tumor 3-Skin (non-melanoma) 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: 1-Polymorphic 2-Monomorphic 9-Unknown 1-Polyclonal 2-Monoclonal 9-Unknown 8. Cell type: 1-T-Cell 2-B-Cell, specify a. If "Other", specify: b. PTLD pathology Epstein-Barr virus stain (EBER or LMP): 1-Positive 2-Negative 9-Unknown/Not done c. PTLD pathology CD 20 stain: 1-Positive 2-Negative 9-Unknown/Not done 9. Location of PTLD: 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:

23 Page 23 of 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 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 Cyclosporine Tacrolimus Sirolimus Mycophenolate mofetil Azathioprine (xx.x) (xxx.x) (xxx.x) (xx.x) (xxxx.x) (xxx.x) 27. Retransplant after PTLD: 1-No 2-Yes a.

24 Page 24 of 35 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:

25 Page 25 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$sitecode] User: Registry Sequence: Date of Treatment: Acute Rejection (REJ) Web Version: 1.0; 1.3; Allograft biopsy performed? 1-No 2-Yes, fine needle aspiration 3-Yes, tissue 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 1-Pulse 2-Tapered 3-Pulse + tapered Methylprednisolone-oral 1-Pulse 2-Tapered 3-Pulse + tapered Methylprednisolone-IV 1-Pulse 2-Tapered 3-Pulse + tapered Cyclosporine 1-Sandimmune 2-Neoral 3-Study 4-Generic Tacrolimus Azathioprine Mycophenolate mofetil ATG/ALG Sirolimus Monoclonal antibody 1-OKT3 2-Basiliximab (Simulect) 3-Daclizumab (Zenapax) 4-Alemtuzamab (Campath) 5-Rituximab (Rituxam) *Additional Options Listed Below

26 Page 26 of Calcineurin trough level: (xxxx.x) a. Calcineurin assay: 1-HPLC 2-TDx 3-Polyclonal RIA 4-Monoclonal RIA-specific 5-Monoclonal RIA-nonspecific *Additional Options Listed Below 4. Sirolimus trough level: (xxxx.x) a. Sirolimus assay: 5. Were other non-maintenance immunosuppressive treatments applied? Specify other immunosuppressive medication: 1-HPLC 2-Liquid chrom/mass spect. 3-Immuno assay 1-No 2-Yes 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. 1-Complete reversal of rejection 2-Partial reversal of rejection 3-Graft failure 4-Patient death Check to unlock and change unit of measurement: 8. CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l 9. Was dialysis used during anti-rejection therapy? 1-No 2-Yes 10. Comments:

27 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for REJ Page 27 of 35 Mono. AB formulation 8-Other 9-Unknown Calcineurin assay: 6-EMIT 7-ELISA 8-IMx

28 Page 28 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$sitecode] User: Registry Sequence: Visit Number: Transplantation Status (STA) Web Version: 1.0; 2.0; Transplant date: 1. Graft status: 1-Functioning 2-Non-functioning 2. Height: (xxx.x) cm 3. Weight: (xxx.x) kg 4. Date height obtained: (mm/dd/yyyy) 5. Tanner stage: Pubic Testicular hair: *Additional Options Listed Below Breast: *Additional Options Listed Below size: 1-Pre-puberty (<=3 cc) 2-Early-puberty (>3-6 cc) 3-Mid-puberty (>6-10 cc) 4-Late puberty (>10-15 cc) 5-Adult (>15 cc) *Additional Options Listed Below Check to unlock and change unit of measurement. 6. CU SI Units Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l 7. Creatinine date: (mm/dd/yyyy) 8. Number of acute rejection episodes since last report: (x) Document each acute rejection episode on an Acute Rejection form. 9. Number of episodes of acute cyclosporine nephrotoxicity: (x) 10. IMMUNOSUPPRESSIVE TREATMENT (Maintenance Only) Medication Daily Maintenance Dose as of Report Date Alternate Day Schedule Formulation Prednisone 1-No 2-Yes Cyclosporine 1-Sandimmune 2-Neoral 3-Study 4-Generic Tacrolimus Azathioprine

29 Page 29 of 35 Mycophenolate mofetil Sirolimus 11. Calcineurin trough level: 12. Sirolimus trough level: (xxxx.x) (xxxx.x) Assay: Assay: 1-HPLC 2-TDx 3-Polyclonal RIA 4-Monoclonal RIA-specific 5-Monoclonal RIA-nonspecific *Additional Options Listed Below 1-HPLC 2-Liquid chrom/mass spect. 3-Immuno assay 13. Were other immunosuppressive agents given? 1-No 2-Yes If Yes, specify: 14. CONCOMITANT DRUG THERAPY Anticonvulsant: 1-No 2-Yes Anti-hypertensive: 1-No 2-Yes Antibiotics: 1-No 2-Yes Growth hormone: 1-No 2-Yes 15. 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 16. Was a malignancy diagnosed during this report period? 1-No 2-Yes If Yes, submit a Targeted Adverse Event form. 17. Comments:

30 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for STA Page 30 of 35 Tanner stage public hair 6-Unknown Tanner stage testicular 6-Unknown Assay: 6-EMIT 7-ELISA 8-IMx

31 Page 31 of 35 North American Pediatric Renal Trials Collaborative Studies Production Release 5.0 [$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? 1-No 2-Yes, hemodialysis 3-Yes, peritoneal dialysis 4-Yes, both 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: 1-Live donor/parent 2-Live donor/sibling 3-Live donor/other related 4-Live donor/unrelated 5-Cadaver 8. Donor age: (xx) 9. Donor sex: 1-Male 2-Female 10. HISTOCOMPATIBILITY DATA OF DONOR HLA-A: HLA-B: HLA-DR: A (xx) A (xx) B (xx) B (xx) 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 1-No 2-Yes 9-Unknown 1-No 2-Yes, Collins 3-Yes, Wisconsin 4-Yes, Unknown 9-Unknown c. Total cold time (xxx) Hours + (xx) Minutes PRE-TRANSPLANT BLOOD TRANSFUSION DATA FOR THIS TRANSPLANT 12.

32 Page 32 of 35 Was donor specific transfusion performed? 13. Specify life-time TOTAL NUMBER of RANDOM TRANSFUSIONS given: 1-No 2-Yes, with immunosuppressive coverage 3-Yes, without immunosuppressive coverage 0-Zero 1-One to five 2-More than five 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 Medication Prednisone Day Post Op Initiated Dose # of Days Formulation Day 30 Dose Methylprednisolone Cyclosporine 1-Sandimmune 2-Neoral 3-Study 4-Generic Tacrolimus Azathioprine Mycophenolate mofetil ATG/ALG Sirolimus Monoclonal Ab 1-OKT3 2-Basiliximab (Simulect) 3-Daclizumab (Zenapax) 4-Alemtuzamab (Campath) 5-Rituximab (Rituxam) *Additional Options Listed Below 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. Anticonvulsant: 1-No 2-Yes 19. Anti-hypertensive: 1-No 2-Yes 20. Antibiotics: 1-No 2-Yes (excluding perioperative)

33 Page 33 of 35 Check to unlock and change unit of measurement: CU SI Units 21. Day 30 Serum creatinine: (xx.x) (xxxx.x) mg/dl µmol/l 22. Day 30 Calcineurin blood level (Cyclosporine or Tacrolimus): 23. Day 30 Sirolimus blood level: POST TRANSPLANT DIALYSIS USE (xxxx.x) (xxxx.x) Assay: Assay: 1-HPLC 2-TDx 3-Polyclonal RIA 4-Monoclonal RIA-specific 5-Monoclonal RIA-nonspecific *Additional Options Listed Below 1-HPLC 2-Liquid chrom/mass spect. 3-Immuno assay 24. Week 1: 1-No 2-Yes 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:

34 Protocol: 1st Transplant Sequence (TRANSA) Additional Selection Options for TRA Page 34 of 35 MaB formulation 8-Other 9-Unknown Assay: 6-EMIT 7-ELISA 8-IMx

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