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

Transcription

1 Page 1 of 19 Targeted Adverse Event(ADV) Version: 1.1; Adverse Event: 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event 6-Other adverse event Adverse Event Date: _ 1. If malignancy, please specify diagnosis: 2. If avascular necrosis or slipped capital femoral epiphyses, record the following: Onset: gfedc 1-Initial gfedc 2-Recurring X-ray confirmation: gfedc 1-No gfedc 2-Yes Bone scan confirmation: gfedc 1-No gfedc 2-Yes 3. If intracranial hypertension, record the following: Opening CSF pressure: (xxx) mmh2o Headache: gfedc 1-No gfedc 2-Yes Papilledema: gfedc 1-No gfedc 2-Yes Nausea & vomiting: gfedc 1-No gfedc 2-Yes Visual changes: gfedc 1-No gfedc 2-Yes 4. If Serious adverse event, please specify: 5. If Other adverse event, please specify:

2 Page 2 of 19 Targeted Adverse Event(ADV Page 2) Adverse Event: 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event 6-Other adverse event Adverse Event Date: _ 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? gfedc 1-No gfedc 2-Yes Hospitalization: gfedc 1-No gfedc 2-Yes Medication: gfedc 1-No gfedc 2-Yes Surgery: gfedc 1-No gfedc 2-Yes Other treatment: gfedc 1-No gfedc 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 c. Frequency: gfedc 1-No gfedc 2-Yes 1-Nutropin 2-Protropin 3-Humatrope 4-Nutropin Depot 9-Other 1-Subcutaneous 2-Intraperitoneal 1-Daily 2-Every other day 3-Three times/week 4-Six times/week 5-Weekly 6-Every other week 7-Monthly 9-Other

3 Page 3 of 19 Targeted Adverse Event(ADV Page 3) Adverse Event: 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event 6-Other adverse event Adverse Event Date: _ d. Dose: (x.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? gfedc 1-No gfedc 2-Yes If Yes, record date: (mm/dd/yyyy) g. Was growth hormone reintroduced? gfedc 1-No gfedc 2-Yes If Yes, did the adverse event recur? gfedc 1-No gfedc 2-Yes If Yes, when? (mm/dd/yyyy) 10. Relationship to growth hormone: 1-Not related- never received 2-Not related 3-Possible 4-Probable 11. Comments:

4 Page 4 of 19 Targeted Adverse Event(ADV Page 4) Adverse Event: 1-Malignancy 2-Avascular necrosis 3-Slipped capital femoral epiphyses 4-Intracranial hypertension 5-Other serious adverse event 6-Other adverse event Adverse Event Date: _ Signature: Date:

5 Page 5 of 19 Chronic Renal Insufficiency Termination(CRI) Version: 1.1; Date of termination: (mm/dd/yyyy) 2. Patient height at termination: (xxx.x) cm 3. Check to unlock and change unit of measurements: Serum creatinine: CU SI Units gfedc gfedc mg/dl gfedc µmol/l 4. Reason for termination: If Other, specify: (xx.x) (xxxx.x) 1-Patient was transplanted 2-Patient initiated maintenance dialysis 3-Patient regained renal function 4-Patient died 9-Other 5. Comments:

6 Page 6 of 19 Chronic Renal Insufficiency Termination(CRI Page 2) Signature: Date:

7 Page 7 of 19 Chronic Renal Insufficiency Status(CRS) Version: 1.1; Visit Number: Date of examination: (mm/dd/yyyy) PHYSICAL DATA 2. Weight: (xxx.x) kg 3. Height: (xxx.x) cm 4. Tanner Stage: Pubic hair: Unknown Breast: 6-Unknown 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) Testicular size: 6-Unknown 5. Are anthropometric measures available? gfedc 1-No gfedc 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 7. Check to unlock and change units of measurement: Serum creatinine: CU SI Units gfedc gfedc mg/dl gfedc µmol/l (xx.x) (xxxx.x)

8 Page 8 of 19 Chronic Renal Insufficiency Status(CRS Page 2) Visit Number: Hematocrit: CU SI Units gfedc % gfedc VF BUN: CO 2 : Inorganic phosphorus: Calcium: Albumin: Alkaline phophatase: (xx.x) (.xxx) (xxx) (xx.x) (xx) (xx) (xx.x) (xx.x) (xx.x) (x.xx) (xx.x) (xx) (xxxx) (xx.xx) gfedc mg/dl gfedc mmol/l gfedc meq/l gfedc mmol/l gfedc mg/dl gfedc mmol/l gfedc mg/dl gfedc mmol/l gfedc g/dl gfedc g/l gfedc IU/mL gfedc µkat/l

9 Page 9 of 19 Chronic Renal Insufficiency Status(CRS Page 3) Visit Number: Hemoglobin: CU SI Units gfedc g/dl gfedc g/l (xx.xx) (xx.xx) 8. Most recent parathyroid hormone: 1-Less than 2x upper normal limit 2-Greater than 2x upper normal limit 9-Unknown Medication Data 9. Is the patient receiving erythropoietin? gfedc 1-No gfedc 2-Yes a. Type: 1-Epogen 2-Procrit 3-Aranesp 9-Other b. Route: 1-Subcutaneous 2-Intraperitoneal 3-Intravenous c. Frequency: 1-Daily 2-Every other day 3-Three times/week 4-Six times/week 5-Weekly 6-Every other week 7-Monthly 9-Other d. Units/dose: 10. Is the patient receiving human growth hormone? gfedc 1-No gfedc 2-Yes a. Type: 1-Nutropin 2-Protropin 3-Humatrope 4-Nutropin Depot 9-Other b. Frequency: 1-Daily 2-Three times/week 3-Two times/week 4-Weekly 5-> Weekly

10 Page 10 of 19 Chronic Renal Insufficiency Status(CRS Page 4) Visit Number: c. Dose: 11. Concomitant Drug Therapy a. Anticonvulsant: gfedc 1-No gfedc 2-Yes b. Antihypertensives: gfedc 1-No gfedc 2-Yes If Yes, number of drugs: (x) c. Prophylactic antibiotics: gfedc 1-No gfedc 2-Yes d. Sevelamer hydrochloride: gfedc 1-No gfedc 2-Yes e. Alkali therapy: gfedc 1-No gfedc 2-Yes f. Immunosuppressives: gfedc 1-No gfedc 2-Yes 1. Prednisone: 1-No 2-Yes, qd 3-Yes, qod Dose: (xxx.x) mg/day 2. Other immunosuppressives: 1-Cyclosporine 2-Cyclophosphamide 3-Mycophenolate mofetil 4-Sirolimus 5-Chlorambucil 6-Tacrolimus 9-Other g. Lipid lowering agents: gfedc 1-No gfedc 2-Yes h. 1,25-dihydroxy Vitamin D (oral): gfedc 1-No gfedc 2-Yes i. Other Vitamin D compounds: gfedc 1-No gfedc 2-Yes j. Iron (oral): gfedc 1-No gfedc 2-Yes k. Iron (IV): gfedc 1-No gfedc 2-Yes l. Parenteral nutrition: gfedc 1-No gfedc 2-Yes m. Supplemental enteral nutrition: 1-Oral gfedc 1-No gfedc 2-Yes 2-NG If Yes, specify: 3-Gastrostomy

11 Page 11 of 19 Chronic Renal Insufficiency Status(CRS Page 5) Visit Number: n. Calcium carbonate: gfedc 1-No gfedc 2-Yes o. Calcium acetate: gfedc 1-No gfedc 2-Yes p. Other calcium supplements: gfedc 1-No gfedc 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: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 13. Orthopedic surgery: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 14. Urinary tract infection: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 15. Hip x-ray: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown a. If Yes, left hip: 1-Normal 2-Slipped capital femoral epiphyses 3-Avascular necrosis 9-Other b. Right hip: 1-Normal 2-Slipped capital femoral epiphyses 3-Avascular necrosis 9-Other 16. Seizures: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 17. Renal biopsy: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 18. Fluid and electrolyte abnormalities: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 19. Blood transfusions: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown If Yes, number of episodes: (x) Education Data 20. Has patient completed high school education? gfedc 1-No gfedc 2-Yes If No: 1-Attends school full time 2-Attends school part-time 3-Receives home schooling only 4-Not attending school, medically capable 5-Not attending school, medically incapable 6-Not of school age

12 Page 12 of 19 Chronic Renal Insufficiency Status(CRS Page 6) Visit Number: 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: gfedc 1-No gfedc 2-Yes b. Hypertension: gfedc 1-No gfedc 2-Yes c. Other cardiovascular: gfedc 1-No gfedc 2-Yes 23. Comments: Signature: Date:

13 Page 13 of 19 Patient Death(DTH) Version: 1.1; Date of death: (mm/dd/yyyy) 2. Cause of death: 01-Infection, viral 02-Infection, bacterial 03-Infection, not specified 04-Cancer/malignancy 05-Cardiopulmonary 06-Hemorrhage 07-Recurrence of original renal disease 08-Dialysis-related complications *Additional Options Available If other, specify cause of death: 3. Graft status at death: 4. Comments: 1-Functioning 2-Non-functioning 3-Not applicable Signature: Date:

14 Page 14 of 19 Lost to Follow Up(LTF) Version: 1.1; Date lost to follow up: (mm/dd/yyyy) 2. Reason for loss: 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 9-Other If Other, specify: 3. Graft status at loss: 4. Comments: 1-Functioning 2-Non-functioning 3-Not applicable Signature: Date:

15 Page 15 of 19 CRIPRA(ENR) Version: 1.1; Enter the date of CRI Initiation to register this participant into the CRI Registry: (mm/dd/yyyy) 2. Patient weight at enrollment: (xxx.x) kg 3. Patient height at enrollment: (xxx.x) cm Check to unlock and change unit of measurement: gfedc 4. CU SI Units Serum Creatinine: gfedc mg/dl gfedc µmol/l (xx.x) (xxxx.x) To qualify for the CRI 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 CRI Registry.

16 Page 16 of 19 CRIPRA(ENR Page 2) Signature: Date:

17 Page 17 of 19 Registration(DEM) Version: 1.1; Date of birth: (mm/dd/yyyy) 2. Race/ethnicity: 1-White 2-Black 3-Hispanic 9-Other 3. Gender: gfedc 1-Male gfedc 2-Female 4. Primary renal 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 06-Familial nephritis - Alport's Syndrome 07-Cystinosis 08-Oxalosis *Additional Options Available If Other, specify diagnosis: 5. Biopsy or nephrectomy confirmation of diagnosis: gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 6. Maternal Paternal Education Score: 0-No formal education 1-Grade 6 or less 2-Grades Grades 10 or more without diploma 4-Grade 12 (High school graduate) 5-Some college/ business/ vocational 6-College degree 7-Graduate work *Additional Options Available 0-No formal education 1-Grade 6 or less 2-Grades Grades 10 or more without diploma 4-Grade 12 (High school graduate) 5-Some college/ business/ vocational 6-College degree 7-Graduate work *Additional Options Available 7. Insurance Information: Does patient have Medicaid? gfedc 1-No gfedc 2-Yes gfedc 9-Unknown Does patient have supplemental private insurance? gfedc 1-No gfedc 2-Yes gfedc 9-Unknown 8. Has patient been transplanted prior to registration: gfedc 1-No gfedc 2-Yes 9. Total number of prior transplants: (x) 10. 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

18 Page 18 of 19 Registration(DEM Page 2) 11. ABO (record for Transplant and Dialysis participants): 1-A 2-B 3-O 4-AB gfedc gfedc gfedc gfedc 12. Histocompatibility data of recipient Record for transplant participants: HLA-A A (xx) A (xx) HLA-B HLA-DR B (xx) B (xx) DR (xx) DR (xx) If assay performed but an allele was not determined, enter '99' Signature: Date:

19 Additional Selection Options Page 19 of 19 DTH: Cause of death: 09-Other, specify 10-Unknown DEM: Primary renal diagnosis: 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 99-Other, specify DEM: Education Score Maternal 9-Unknown