North American Pediatric Renal T rials Collaborative Studies
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User:
Targeted Adverse Event (ADV)
Web V ersion: 1 .0; 2.0 ; 06-2 0-13
Adve rse Ev e nt:
Adv e rse Ev ent Date :
1.
If m alignancy , ple ase specify dia gnosis:
2. If av asc ular ne cros is or slippe d capital fe m ora l epiphy se s, re co rd the following :
On set:
1-Ini tial
X-ray con firmation:
1-No
2-Ye s
Bo ne scan confirmation:
1-No
2-Ye s
2-Recurr ing
3. If intrac ranial hy pe rte ns ion, record the foll owing:
Op ening CSF p ressu re:
4.
(xxx) mmH2O
Heada ch e:
1-No
2-Ye s
Pa pillede ma:
1-No
2-Ye s
Nausea & vo miting:
1-No
2-Ye s
Visual ch anges:
1-No
2-Ye s
If S erious adv erse e v e nt, please specify:
5.
If O the r a dv e rse e v ent, p lease spe cify:
6.
Intensity:
7.
Ou tcome :
8.
Tre atment re quire d?
1-No
2-Ye s
Hospitalization:
1-No
2-Ye s
Medication:
1-No
2-Ye s
Sur gery:
1-No
2-Ye s
Other treatment:
1-No
2-Ye s
1-No
2-Ye s
If O the r treatment, specify:
9.
Was p ati ent receiving gr owth hor mone at the time of ad ve rse even t?
If receivi ng growth h ormone, record th e fol lo wi ng:
a.
Type:
b.
Route
c.
Freque ncy:
d.
Dose:
(xx.xx) mg/d ose
e.
Dosage of g rowth hor mone was:
f.
If do se chan ged, p rovide date:
g.
(mm/d d/yyyy)
Did the adverse eve nt aba te ?
1-No
2-Ye s
Was g rowth hor mone rei ntro duced?
1-No
2-Ye s
1-No
2-Ye s
If Yes, did the adverse event recur ?
10.
Relationship to growth h ormon e:
11.
Comments:
If Y es, record date:
If Y es, when?
(mm/dd/yyyy)
(mm/dd /yyyy)
Additional Selection Options for ADV
Adve rse E ve nt (ke y field):
1- 1-Malign ancy
2- 2-Ava scular ne cro sis
3- 3-Slip ped ca pital femoral epiph yses
4- 4-Intracrania l h ype rte nsi on
5- 5-Other serious adverse event
6- 6-Other adverse event
Freque ncy :
6- 6-Every o the r wee k
7- 7-Monthly
9- 9-Other
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Chronic Kidney Disease T erm ination (CRI)
Web V ersion: 1 .0; 1.4 ; 06-2 0-13
Re gis try Se que nce :
1.
Date of ter mination:
2.
Patient heigh t at termin ati on:
(mm/dd/yyyy)
(xxx.x) cm
Ch eck to un lock and chang e u nit of measurements:
3.
CU
Ser um cre atinine:
4.
Reason fo r termination:
5.
Comme nts:
If Other , sp ecify:
SI
(xx.x)
Units
(xxxx.x)
mg /dL
µmol/L
Additional Selection Options for CRI
Re ason for te rm ination:
9- 9-Other
Production Release 14.0
North American Pediatric Renal T rials Collaborative Studies
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User:
Chronic Kidney Disease Status (CRS)
Web V ersion: 1 .0; 1.6 ; 06-2 0-13
Re gis try Se que nce :
V isit Numbe r:
1.
Date o f examination:
(mm/d d/yyyy)
PHY SICAL DATA
2.
Weigh t:
(xxx.x) kg
3.
Heigh t:
(xxx.x) cm
4. Tann er Sta ge:
Pubic hair:
5.
Brea st:
Testi cul ar size :
Are anthropo metric measures ava ilable ?
1-No
2-Y es
If Ye s, in dicate :
a.
b.
6.
Mid arm circumference:
(xx.x) cm
Tri cep skin fold thickn ess:
(xx.x) mm
Blo od pressure:
(xxx)
/
(xxx) mm Hg
Check to u nlock and chan ge units of measurement:
7.
CU
SI
Se rum creatinine :
(xx.x)
Hema tocrit:
(xx.x)
BUN:
CO2:
(xxx)
(xx)
Units
( xxxx.x)
mg/d L
µmol/L
(.xxx)
%
VF
(xx.x)
mg/d L
mmol/L
mEq/L
mmol/L
(xx)
Ino rgani c phosph orus:
(xx.x)
(x.xx)
mg/d L
mmol/L
Calcium:
(xx.x)
(x.xx)
mg/d L
mmol/L
Albumin:
(xx.x)
g/dL
g /L
Alkaline ph ophatase:
(xxxx)
IU/mL
µKat/L
g/dL
g /L
Hemo globin :
8.
(xx.xx)
( xxx)
(xx.xx)
(xxxx.xx)
Most recent parathyroid ho rmone :
Medication Data
9.
Is the patien t receiving erythropoi etin ?
a.
Type:
1-No
2-Y es
b.
Route:
c.
Frequ ency:
d.
10.
Units/dose:
Is the patien t receiving human growth h ormon e?
a.
Type:
b.
Frequ ency:
c.
1-No
2-Y es
Dose:
11. Concom ita nt Drug The ra py
a.
Antico nvu lsa nt:
1-No
2-Y es
b.
Antihypertensives:
1-No
2-Y es
c.
Pro phylactic antibiotics:
1-No
2-Y es
d.
Se vel amer hydrochlo ride:
1-No
2-Y es
e.
Alkali the rapy:
1-No
2-Y es
Immunosupp ressives:
1-No
2-Y es
f.
1.
Pre dnisone:
2.
Other immunosup pressi ves:
If Yes, number of dr ugs:
Dose:
g.
Lip id l owering age nts:
1-No
2-Y es
h.
1,25-d ihydroxy Vitamin D (oral ):
1-No
2-Y es
i.
Other Vitamin D comp ound s:
1-No
2-Y es
j.
Iron (o ral):
1-No
2-Y es
k.
l.
Iron (IV):
1-No
2-Y es
Pa renteral nutrition:
1-No
2-Y es
1-No
2-Y es
1-No
2-Y es
m.
Su pplemental e nte ral nutrition:
n.
Calcium carbon ate :
o.
Calcium acetate:
1-No
2-Y es
p.
Other calcium supple ments:
1-No
2-Y es
(x)
(xxx.x) mg/day
If Yes, specify:
Ev ents Data
If thi s i s the in itia l CRI Sta tus fo rm, has p ati ent ever h ad th e e ven t? If th is is n ot the in itia l CRI Sta tus fo rm, has the pati ent ha d the event si nce the l ast repo rt?
12.
Urolog ic surger y:
1-No
2-Y es
9-Unknown
13.
Orthop edic sur gery:
1-No
2-Y es
9-Unknown
14.
Urinar y tr act infection :
1-No
2-Y es
9-Unknown
15.
Hip x-ray:
1-No
2-Y es
9-Unknown
a.
If Y es, left hip:
b.
Right hip:
16.
Se izures:
1-No
2-Y es
9-Unknown
17.
Renal bio psy:
1-No
2-Y es
9-Unknown
18.
Fluid and ele ctrolyte abnormalities:
1-No
2-Y es
9-Unknown
19.
Blo od tra nsfusions:
1-No
2-Y es
9-Unknown
If Y es, numb er of episod es:
(x)
Educ ation Da ta
20.
Has p atie nt compl ete d h igh schoo l e ducati on?
1-No
2-Y es
If No:
Hospitalization Data
Omit for i ni ti al CRI Status Form
21.
To tal days h ospita lized since l ast repor t:
22.
(xxx)
Numb er o f hospitaliza tio ns since last repor t:
(xx)
Reasons for hospi ta li zatio n:
23.
a.
Infecti on:
1-No
2-Y es
b.
Hypertension:
1-No
2-Y es
c.
Other cardio va scular :
1-No
2-Y es
Comments:
Additional Selection Options for CRS
Pubic hair:
6- 6-Unknown
Te sticular size :
6- 6-Unknown
Freque ncy :
6- 6-Every o the r wee k
7- 7-Monthly
9- 9-Other
O the r im m unosuppre ssive s:
6- 6-Tacroli mus
9- 9-Other
If No:
6- 6-Not of schoo l ag e
Production Release 14.0
North American Pediatric Renal T rials Collaborative Studies
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User:
Registration (DEM)
Web V ersion: 1 .0; 1.4 ; 06-2 0-13
1.
Does you r site partici pate in the NAP RT CS Regi stries?
2.
Date o f birth:
3.
Race/eth nicity:
4.
Ge nder:
5.
Pri mary r enal diag nosis:
1- No
2- Y es
(mm/d d/yyyy)
1-Male
2- Fe male
If O th er, specify diag nosis:
6.
Bio psy or neph rectomy confirmation of diagno sis:
7.
1-No
Maternal
2-Y es
9-Unknown
Paterna l
Ed ucatio n S co re:
8. Insurance Informa tio n:
9.
Does patient h ave Medi cai d?
1-No
2-Y es
9-Unknown
Does patient h ave supp lemen tal private insuran ce?
1-No
2-Y es
9-Unknown
Has p atie nt bee n tran sp lanted prior to r egistra tio n:
10.
To tal number of pr ior tra nsp lants:
11.
Has p atie nt ever received main te nance dialysis?
1-No
If Y es, sp eci fy d ate o f fir st maintenan ce dia lysis:
12.
(xx) Mo nth /
ABO (record for Tran spl ant an d Dial ysis pa rti cipa nts):
1-A
13. Histocompa tib ility data of recipie nt
Reco rd for transpl ant p articip ants:
HLA-A
A
(xx)
A
(xx)
HLA-B
B
(xx)
B
(xx)
HLA-DR
DR
(xx)
2-Y es
(x)
DR
(xx)
If a ssay performed
bu t an allele was not
de termined, enter '99 '
2-B
(xxxx) Ye ar
3-O
4- AB
Additional Selection Options for DEM
Prim ary re nal diagnosis:
06 -06-Familial neph ritis - Alpo rt's S ynd rome
07 -07-Cystino sis
08 -08-O xalosis
09 -09-Con genital neph roti c synd rome
10 -10-Focal segmen tal glo merul oscler osi s
11 -11-Membrano proliferative glome rulone phritis - Type I
12 -12-Membrano proliferative glome rulone phritis - Type II
13 -13-Membrano us ne phropa thy
14 -14-Id iopathic cre scentic g lomeru lonep hritis
15 -15-Chro nic gl omeru loneph riti s
16 -16-P yel oneph ritis/interstitial nep hritis
17 -17-Reflux nep hropa thy
18 -18-S ID w/S LE neph ritis
19 -19-S ID w/Hen och -Schonle in purpu ra n ephri tis
20 -20-S ID w/B erger 's n ephritis ( IgA)
21 -21-S ID w/Weg ener's gr anulo matosis
22 -22-S ID w/o the r
23 -23-Wilms' tumor
24 -24-Ren al in fa rct
25 -25-Diab etic glomerulon ephritis
26 -26-S ickle cell nephr opathy
27 -27-Hemolytic uremic synd rome
28 -28-Drash syn drome
30 -30-Unknown
99 -99-O the r, specify
Education Sc ore Mate rnal
5- 5-Some coll ege/ b usi ness/ vocationa l
6- 6-College de gree
7- 7-Gra duate wo rk
9- 9-Unknown
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Production Release 14.0
User:
Patient Death (DTH)
Web V ersion: 1 .0; 1.1 ; 06-2 0-13
1.
Date of death:
2.
Cause of dea th:
If other, sp eci fy cau se of d eath:
3.
Graft statu s at d eath:
4.
Comme nts:
(mm/dd/yyyy)
Additional Selection Options for DTH
Cause of dea th:
06 -06-Hemorrhag e
07 -07-Recurre nce o f origin al renal disease
08 -08-Dialysis-related compli cation s
09 -09-O the r, specify
10 -10-Unknown
North American Pediatric Renal T rials Collaborative Studies
Production Release 14.0
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CRIPRA (ENR)
Web V ersion: 1 .0; 1.4 ; 06-2 0-13
1.
E nter the date of CKD Initiation to reg ister this pa rticipa nt into th e CKD
Re gistry:
(mm/dd/yyyy)
2.
E nter the date of CKD Initiation to reg ister this pa rticipa nt into th e CKD
Re gistry:
(mm/dd/yyyy)
3.
P atient weigh t at e nrollment:
(xxx.x) kg
4.
P atient he ight a t enro llment:
(xxx.x) cm
Ch eck to un lock and chang e u nit of measurement:
5.
CU
Ser um Cr eatinine:
SI
(xx.x)
Units
(xxxx.x)
mg/dL
µmol/L
To qua li fy fo r the CKD Reg istr y patie nts must have a crea ti ni ne cl ear ance o f le ss tha n or e qual to 75 ml/ mi n /1 73 m3 , based on the Schwa rtz formul a:
Cre atinine Cle arance :
Patien ts who h ave re cei ved main ten ance dia lysis o r who ha ve bee n tran sp lan ted do no t qual i fy for the CKD Regi stry.
North American Pediatric Renal T rials Collaborative Studies
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Lost to Follow Up (LTF)
Web V ersion: 1 .0; 1.3 ; 06-2 0-13
1.
Date lo st to fo llow u p:
2.
Reason fo r lo ss:
If Other , sp ecify:
3.
Graft statu s at lo ss:
4.
Comme nts:
(mm/dd/yyyy)
Additional Selection Options for LTF
Re ason for loss:
8- 8-Admini strative Closure
9- 9-Other
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Malignancy Form (MAL)
Web V ersion: 1 .0; 2.0 ; 06-2 0-13
Ma lignancy da te :
1.
Type of malign ancy:
2.
Sp ecify maligna ncy:
3.
Is this malign ancy a PTL D?
1 -No
2 -Yes
If thi s mal ig nancy i s a "PTLD", p lea se compl ete the remai nde r of for m.
4.
Heigh t at dia gnosis o f PTLD:
(xxx.x) cms
5.
Weigh t at di agnosis o f PTL D:
(xxx.x) kg
6.
Type of P TLD:
7.
Clona lity:
8.
Cell type :
a.
b.
1 -T-Cell
2-B -Ce ll
9 -Other, spe cify
If "O th er", specify:
PT LD pa tho logy E pstein -Barr virus stain (EBE R or
LMP):
c.
PT LD pa tho logy CD 2 0 stain:
1 -Positive
2- Ne gative
9- Unkno wn /Not d one
1 -Positive
2- Ne gative
9- Unkno wn /Not d one
9. Location of PT LD:
a.
Allogra ft
1 -No
2 -Yes
b.
Lymph no de
1 -No
2 -Yes
c.
Central nervous syste m
1 -No
2 -Yes
d.
Other
1 -No
2 -Yes
1.
If "Other", sp eci fy
10. Pre-tran spl ant EB V serolo gy:
a.
Donor :
1 -Positive
2- Ne gative
9- Unkno wn /Not d one
b.
Recipient:
1 -Positive
2- Ne gative
9- Unkno wn /Not d one
11.
12.
Se rum cr eatinine at d iagno sis of PTL D:
Last p rior se rum creatinine value (3 mo nth s before
diagn osis):
13.
Date o f last prio r seru m cre atin ine va lue:
( xx.x) mg/dl OR
(xxxx.x) µmol/L
( xx.x) mg/dl OR
(xxxx.x) µmol/L
(mm/dd/yyyy)
Intervention Data
14.
Reduction of Immuno sup pression:
a.
15.
Anti-CD2 0 a ntib ody u se:
a.
If "Y es", number of do ses:
b.
Total dose administer ed:
16.
1 -No
2 -Yes
If "Y es", specify type( s) of re ductio n:
Alpha interferon use:
a.
If "Y es", number of do ses:
b.
Total dose administer ed:
1 -No
2 -Yes
(xxx)
(xxxx.xx) mg
1 -No
2 -Yes
(xxx)
(xxxx.xx) mg
17.
Chemoth erapy use d:
a.
1 -No
2 -Yes
If "Y es", regi men used:
b.
If "Y es", number of cycle s:
(xxx)
c.
If "Y es", dura tio n o f th erapy in months:
(xxx) Mon ths
18.
Anti-vi ral the rapy u se :
a.
b.
Dose a dmini stered :
c.
Duration of ther apy:
19.
1 -No
(xxxx.xx) mg/day
(xxx) Mon ths
Su rgical reduction of ma ss:
a.
20.
If "Y es", allog raft neph recto my:
Concomi tan t rejection tre atment:
a.
2 -Yes
If "Y es", age nt used:
1 -No
2 -Yes
1 -No
2 -Yes
1 -No
2 -Yes
1 -No
2 -Yes
If "Y es", age nt used:
Outcome Data
21.
Viral load by PCR:
a.
If "Y es", value at d iagnosis:
(xxxxxxxxxx.x)
b.
If "Y es", value at 1 mo nth after diagn osi s:
(xxxxxxxxxx.x)
c.
If "Y es", value at time of increase in
immu nosuppre ssion :
22.
Se rum cr eatinine afte r P TLD trea tme nt:
23.
Date o f serum creatinine after tre atment:
24.
Gra ft l oss:
a.
(xxxxxxxxxx.x)
( xx.x) mg/dl OR
(mm/dd/yyyy)
1 -No
If "Y es", date:
Date i mmun osu ppression increased ag ain:
26.
Immunosupp ressio n a fter PTL D resolution :
(mm/dd/yyyy)
( xxx.x)
Ta cr olimus
( xxx.x)
Si rolimu s
Myco pheno late mofe til
Azathiop rine
Retransplan t after PT LD:
28.
1 -No
2 -Yes
1 -No
2 -Yes
(xx.x)
(xxxx.x)
( xxx.x)
If "Y es", date of retran sp lant:
Recurren ce of PTLD in r etr ansplant:
a.
2 -Yes
(xx.x)
Cyclo sp orine
a.
1 -No
Dose
Pr ednisone
27.
If "Y es", date of recur rence:
Comments:
2 -Yes
(mm/dd/yyyy)
25.
Agent
Units
(mm/dd/yyyy)
(mm/dd/yyyy)
(xxxx.x) µmol/L