dd15-1507 supporting documentation.pdf

Centers for Disease Control and Prevention, National Center on Birth Defects and

Developmental Disabilities

Public Health Surveillance for the Prevention of Complications of Bleeding Disorders

CDC-RFA-DD15-1507

Supporting Information

Table of Contents

Division of Blood Disorders Acceptance Testing for External Data Collection and Transfer Systems

CDC-RFA-DD15-1507: Strategy 2, Activity 2 (Annual Minimal Patient-Level Data Elements)

CDC-RFA-DD15-1507: Data Elements Currently Collected under DD11-1103/DD14-1409 for Strategy 2, Activity 3

(Longitudinal, Patient-Level Health Indicator Data)

CDC-RFA-DD15-1507: Strategy 2, Activity 4 (Patient-Level Mortality Data Elements)

CDC-RFA-DD15-1507: Regional Organization of the United States Hemophilia Treatment Center Network

(USHTCN)

CDC-RFA-DD15-1507: Strategy 3, Activity 1 and 2 (Specimen Form Elements)

Division of Blood Disorders Acceptance Testing for External Data Collection and Transfer

Systems

CDC’s Division of Blood Disorders (DBD) will work with collaborators who wish to submit data for DBD-sponsored surveillance projects. In most instances DBD will provide a data collection and submission system. Collaborators who wish to submit data via another route will be required to provide documentation about their system and participate in testing to ensure accuracy and completeness of data transfer (acceptance testing). DBD will initiate the acceptance testing procedure after the collaborator has provided documentation and indicated that they are ready to transfer records to DBD.

This is an outline of the major components of DBD’s acceptance testing process:

DBD will request the collaborator to train DBD personnel on the use of their system.

The collaborator will set up user accounts for DBD personnel that will be exactly like the user accounts set up for data entry by collaborators.

The collaborator will provide, at a minimum, data dictionaries, edit checks and business rules, and mapping algorithms for generated variables, and quality assurance/quality control documentation.

DBD will enter sample records into the collaborator’s system and maintain a separate record of the data values entered into the collaborator’s system.

The collaborator will process the data entered by DBD and provide electronic records in a mutually agreeable, nonproprietary format (such as a comma-separated file) to DBD.

DBD will compare the provided electronic records to the DBD record of data entered.

The system will be considered to have met acceptance criteria if no data value discrepancies are detected between the electronic records and the DBD records except for key entry errors.

CDC-RFA-DD15-1507: Strategy 2, Activity 2 (Annual Minimal Patient-Level Data Elements)

GENERAL INFORMATION

Form completed by

Form submitted date

HTC ID

Subject ID

Year of visit at which information was collected

PATIENT INFORMATION

1. Year of Birth

2. Gender

3. Ethnicity

4. Race

5. Zip code of residence at time of visit (first 3 digits only)

6. Health Insurance status at time of visit (Insured, Uninsured, Unknown)

7. Primary bleeding disorder diagnosis

8. Baseline factor activity

9. VWF:RCof

10. VWF:Ag

11. History of HCV infection?

12. History of HIV infection

CDC-RFA-DD15-1507: Data Elements Currently Collected under DD11-1103/DD14-1409 for Strategy 2, Activity 3 (Longitudinal, Patient-

Level Health Indicator Data)

Data Elements Collected About Each Participant upon Enrollment

ADMINISTRATIVE INFORMATION

Form completed by

HTC ID

Subject ID Date of visit

Did this participant give permission to store his/her blood specimens for future testing?

Yes/No

Did this patient participate in the Universal Data Collection (UDC) project?

Yes/No (skip to #1)/Unknown (skip to #ME1)

If your institution does NOT allow linkage to UDC data, skip to #ME1.

Did this participant give permission to link data from this project to his/her UDC data?

Yes/No (skip to #ME1)

If yes, is the CDC ID known? Yes/No (skip to #ME1)

If yes, then: CDC ID/Date of last UDC visit:

PATIENT INFORMATION

ME1. Date of Birth (M/Y or D/M/Y)

ME2. Gender (Sex): Male Female

ME3. Ethnicity (check one): Hispanic, Latino/a, or Spanish origin

Not Hispanic, Latino/a, or Spanish origin

Unknown

ME4. Race (check one or more): American Indian/Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Unknown

1. Weight (most recent): __ __kg/Date collected/ Weight unknown

2. Height (most recent): __ __ cm/Date collected/ Height unknown

ME5. Zipcode: __ __ __ __ __

3. Health insurance:

Commercial insurance ....................................................... Primary

Military Health Care (TRICARE/VA/Champ-VA) ................. Primary

Medicaid ............................................................................ Primary

Medicare ........................................................................... Primary

State programs .................................................................. Primary

Data Elements Collected About Each Participant in Subsequent Years of Participation

ADMINISTRATIVE INFORMATION

Form completed by

HTC ID

Date of visit

1. Weight (most recent): __ __kg/Date collected/ Weight unknown

2. Height (most recent): __ __ cm/Date collected/ Height unknown

3. Zipcode: __ __ __ __ __

4. Health insurance:

Commercial insurance ....................................................... Primary

Military Health Care (TRICARE/VA/Champ-VA) ................. Primary

Medicaid ............................................................................ Primary

Medicare ............................................................................ Primary

State programs .................................................................. Primary

Indian Health Service ........................................................ Primary

Other ................................................................................ Primary

Uninsured

Unknown

4. Patient education level: check the highest education level completed by the patient.

None Some college

Pre-elementary 2-year college degree (Associates)

Primary / Secondary 4-year college degree (Bachelors)

5. Enter grade 1-12 __ __ Advanced degree (Masters, Doctorate or professional)

GED or equivalent Other

Technical school Unknown

Patients <18 years old only; otherwise skip to #8.

6. Parental education level: check the highest education level completed by either parent.

None Some college

Pre-elementary 2-year college degree (Associates)

Primary / Secondary 4-year college degree (Bachelors)

7. Enter grade 1-12 __ __ Advanced degree (Masters, Doctorate or professional)

GED or equivalent Other

Technical school Unknown

Patients >/= 18 years old only; otherwise skip to #10.

8. Patient employment status (check one):

Employed full-time (skip to #10)

Employed part-time (skip to #10)

Not employed

Unknown employment status (skip to #10)

9. If not employed, check one of the following:

Child or student Retired

Homemaker Other

Able, but not currently working Unknown

Disabled

10. Diagnosis (check all that apply) Clotting Factor Deficiency Baseline clotting factor activity Age or Date diagnosed

VIII (8) ................................. __ __ __.__ __% .. <1% ....... Activity unknown ... __ __/Unk

IX (9) ................................... __ __ __.__ __% .. <1% ....... Activity unknown ... __ __/Unk

I (afibrinogenemia) (1) ........ __ __ __.__ __ mg/dL ............ Activity unknown ... __ __/Unk

I (dysfibrinogenemia) (1) .... __ __ __.__ __ mg/dL ............ Activity unknown ... __ __/Unk

I (hypofibrinogenemia) (1) . __ __ __.__ __ mg/dL ............ Activity unknown ... __ __/Unk

I (Factor 1, hereditary, ........ __ __ __.__ __% .. <1% ....... Activity unknown ... __ __/Unk unspecified)

II (prothrombin) (2) ............ __ __ __.__ __% .. <1% ....... Activity unknown ... __ __/Unk

Indian Health Service ........................................................ Primary

Other ................................................................................. Primary

Uninsured

Unknown

5. Patient education level: check the highest education level completed by the patient.

None Some college

Pre-elementary 2-year college degree (Associates)

Primary / Secondary 4-year college degree (Bachelors)

6. Enter grade 1-12 __ __ Advanced degree (Masters, Doctorate or professional)

GED or equivalent Other

Technical school Unknown

Patients >/= 18 years old only; otherwise skip to #10.

7. Patient employment status (check one):

Employed full-time (skip to #9)

Employed part-time (skip to #9)

Not employed

Unknown employment status (skip to #9)

8. If not employed, check one of the following:

Child or student Retired

Homemaker Other

Able, but not currently working Unknown

Disabled

V (5) .................................... __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk

V-VIII ................................... __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk (Combination 5 and 8)

VII (7) .................................. __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk

X (10) .................................. __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk

XI (11) ................................. __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk

XIII (13) ............................... __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk

PAI-1 deficiency .................. .__ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk (plasminogen activator inhibitor-1 deficiency) α2anti-plasmin deficiency . __ __ __.__ __% <1% ....... Activity unknown ... __ __/Unk (α2-AP)

Von Willebrand disease (VWD) Age or Date diagnosed

VWD Type 1 ................................................................................................... __ __/Unknown

VWD Type 1C ................................................................................................. __ __/Unknown

VWD Type 2A ................................................................................................ __ __/Unknown

VWD Type 2B ................................................................................................. __ __/Unknown

VWD Type 2M ............................................................................................... __ __/Unknown

VWD Type 2N ................................................................................................ __ __/Unknown

VWD Type 2, type unknown .......................................................................... __ __/Unknown

VWD Type 3 ................................................................................................... __ __/Unknown

VWD type unknown ...................................................................................... __ __/Unknown

VWD Other .................................................................................................... __ __/Unknown

VWF activity (lowest ever):

__ __ __.__ __% OR <lower limit of detection Unknown

VWF:Ag (same date as VWF activity above or lowest ever if VWF activity is unknown):

__ __ __.__ __% OR <lower limit of detection Unknown/Not collected on same date

FVIII Level (same date as VWF activity above or same date as VWF:Ag if VWF is unknown):

__ __ __.__ __% OR <1% Unknown/Not collected on same date

Inherited or Functional Platelet Disorder Age or Date diagnosed

Bernard Soulier .............................................................................................. __ __/Unknown

Glanzmann’s thrombasthenia ....................................................................... __ __/Unknown

Grey platelet syndrome ................................................................................. __ __/Unknown

Hermansky-Pudlak syndrome ....................................................................... __ __/Unknown

Inherited thrombocytopenia ......................................................................... __ __/Unknown

Release defect ............................................................................................... __ __/Unknown

Storage pool defect ....................................................................................... __ __/Unknown

Hereditary platelet function disorder............................................................ __ __/Unknown

Bleeding Disorder, no laboratory diagnosis

Blood coagulation disorder with prolonged coagulation time ...................... __ __/Unknown

Blood coagulation disorder with prolonged bleeding time ........................... __ __/Unknown

Blood coagulation disorder with impaired clot retraction time .................... __ __/Unknown

11. Age or Date of first bleed: Date/Date unknown/NA - has never had a bleed

12. Date of first treatment for bleeding with any source of clotting factor (including clotting factor concentrates, plasma or cryoprecipitate) or non-factor replacements such as Stimate (DDAVP) or an antifibrinolytic:

Date/Date unknown/NA - has never received treatment for bleeding

Patients <2 years of age only; otherwise skip to #14.

13. Method of delivery (check all that apply):

Vaginal, unassisted C-Section, Elective

Vaginal with forceps C-Section, Emergent/Non-elective

Vaginal with vacuum C-Section, type unknown

Vaginal, assistance unknown Unknown

14. Is there a history of this congenital bleeding disorder (including a known carrier) in any blood relative of this patient?

Yes/No/Unknown

15. Is the specific genetic mutation causing this patient’s bleeding disorder known?

Yes/No/Unknown

16. In the past 12 months, where has the patient received services from the HTC (mark all that apply)?

HTC’s primary location

HTC outreach clinic

HTC telemedicine session or telemedicine clinic

If the patient has been diagnosed with a clotting factor deficiency, including VWD, answer question 17; otherwise, skip to question #28.

17. Most recent available inhibitor titer result:

. BU/mL Not detected Date drawn (MM/DD/YY)

No results available

18. Has the patient ever had a positive inhibitor titer? Yes (skip to #20)/No/Unknown

19. In the absence of a Bethesda assay, has the patient ever been diagnosed with or suspected to have an inhibitor based on clinical evidence?

Yes/No (skip to #28)/Unknown (skip to #28)

If yes, then If the patient has more than one clotting factor deficiency, or vWD, answer question #20; otherwise, skip to #21.

20. To which factor was an inhibitor detected (mark all that apply)?

FVIII (8) FXI (11)

FIX (9) FXIII (13)

FI (fibrinogen) VWF

FII (2) PAI-1 deficiency

FV (5) α2anti-plasmin deficiency

FVII (7) Unknown

FX (10)

9. Since the last surveillance visit, have any blood relative(s) of the patient been diagnosed with any of the same congenital bleeding disorder(s) as this patient (including new carrier diagnosis)? Yes/No/Unknown

10. Since the last surveillance visit, has the specific genetic mutation causing this patient’s bleeding disorder been determined? Yes/No/Unknown

11. Since the last surveillance visit, where has the patient received services from the HTC (mark all that apply)?

HTC’s primary location

HTC outreach clinic

HTC telemedicine session or telemedicine clinic

If the patient has been diagnosed with a clotting factor deficiency including VWD, answer question #12 otherwise skip to question # 19.

12. Most recent inhibitor titer result:

. (BU/mL) Not detected Date Drawn: (MM/DD/YY)

No results available

21. Date inhibitor was first detected: Date/Date unknown

If the inhibitor was to FVIII or FIX answer #22; otherwise, skip to #28.

22. What was the highest historic inhibitor titer ever?

. BU/mL Unknown

23. Does the patient have a history of immune tolerance induction (ITI)?

Yes/No (skip to #26)/Unknown (skip to #26)

If yes,

24. Has the patient undergone more than one course of ITI?

Yes/No/Unknown

25. What was the highest historic inhibitor titer prior to initiation of the first course of ITI?

. BU/mL Unknown

26. Does the patient have a history of immune modulation therapy for treatment of an inhibitor? Yes/No/Unknown

27. For bleeding events requiring treatment, which of the following is/are currently used by this patient? Mark all that apply. If the patient is currently undergoing ITI, do not consider doses that are part of the ITI regimen; consider only doses used to treat bleeding events.

FVIII or FIX concentrates If FVIII or FIX concentrates, then:

Routine doses and frequency

Increased doses or frequency or both

Unknown whether dose or frequency is routine or increased

Bypassing agents

Antifibrinolytics

Corticosteroids

Other

Unknown

28. Treatment regimen currently practiced by patient (check one):

Prophylaxis- Continuous

Prophylaxis- Continuous with by-passing agents plus ITI

Prophylaxis- Menstrual bleeding

Prophylaxis- Event-based, short-term or intermittent (skip to #35)

Immune tolerance induction without continuous prophylaxis with a by-passing agent (skip to #35)

Episodic (on-demand) (skip to #35)

If patient does NOT use clotting factor concentrate for prophylaxis, skip to #35.

If the patient has ever had a positive inhibitor titer, or been clinically diagnosed with an inhibitor, to FVIII or FIX, answer question #13; otherwise, skip to #19.

13. Since the last surveillance visit, what was the highest inhibitor titer?

. BU/mL Unknown

14. Since the last surveillance visit, has the patient been on immune tolerance therapy (ITI) at any time? Yes/No (Skip to #17)/Unknown (Skip to #17)

If yes,

15. Please describe the patient’s use of ITI since the last surveillance visit (mark all that apply):

The patient began ITI for the first time ever

16. What was the highest historic inhibitor titer prior to the initiation of the first course of ITI?

. BU/mL Unknown

The patient continued a course of ITI begun at or before the last surveillance visit

The patient began a new course of ITI following previous ITI

17. Since the last surveillance visit, has the patient been on immune modulation therapy for treatment of an inhibitor at any time? Yes/No/Unknown

18. Currently, for bleeding events requiring treatment, which of the following is/are used by this patient? Mark all that apply. If the patient is currently undergoing ITI, do not consider doses that are part of the ITI regimen; consider only doses used to treat bleeding events.

FVIII or FIX concentrates If FVIII or FIX concentrates, then:

Routine doses and frequency

Increased doses or frequency or both

Unknown whether dose or frequency is routine or increased

Bypassing agents

Antifibrinolytics

Corticosteriods

Other

Unknown

19. Treatment regimen currently practiced by patient (check one):

Prophylaxis-Continuous

Prophylaxis-Continuous with by-passing agents plus ITI

Prophylaxis- Menstrual bleeding

Prophylaxis- Event based, short-term or intermittent (skip to #27)

Immune tolerance induction without continuous prophylaxis with a by-passing agent (skip to #27)

Episodic (on demand) (skip to #27)

If patient does NOT use clotting factor concentrate for prophylaxis, skip to #27

If on continuous prophylaxis or prophylaxis for menstrual bleeding then,

29. Date or age at which continuous prophylaxis or prophylaxis for menstrual bleeding was first started:

Date : //

OR

Age: Days/ mos/ years (check one) or Approximate age (if specific age unknown):

<3 years of age

3-6 years of age

> 6 years of age

OR

Date or age unknown

30. History of joint bleeds prior to first beginning continuous prophylaxis or prophylaxis for menstrual bleeding (check one):

Fewer than 2 bleeds total (that is, 0 or 1 bleed total) into the large joints (ankle, knee, hip, elbow or shoulder)

2 or more bleeds total into the large joints (ankle, knee, hip, elbow or shoulder)

Unknown

31. Current clotting factor product used for continuous prophylaxis or prophylaxis for menstrual bleeding (check all that apply):

Advate Hemofil M Profilnine SD

Alphanate Humate-P Proplex T

AlphaNine SD Hyate:C Recombinate

Autoplex T Koate-DVI ReFacto

Bebulin VH Kogenate RiaSTAP (fibrinogen, FI)

BeneFIX Kogenate FS Wilate

Bioclate Konyne 80 Xyntha

Corifact (FXIII) Monarc-M

FEIBA NF Monoclate-P Unknown

FEIBA VH Immuno Mononine Other, specify ____________

Fibrogammin P (FXIII) NovoSeven (FVIIa)

Helixate Novoseven RT (FVIIa)

Helixate FS Novo13 (rXIII-A2)

32. Current prescribed clotting factor dose for continuous prophylaxis or prophylaxis for menstrual bleeding:

Dose 1: ,. Units or mg/dose

Dose 2: ,. Units or mg/dose N/A- no second dose

If on continuous prophylaxis or prophylaxis for menstrual bleeding then:

20. Since the last surveillance visit, has the patient started continuous prophylaxis or prophylaxis for menstrual bleeding for the first time ever?

Yes/No (skip to # 23)/Unknown (skip to # 23)

21. Date or age at which continuous prophylaxis or prophylaxis for menstrual bleeding was first started:

Date: //

OR

Age: Days/ mos/ years (check one) or Approximate age (if specific age unknown):

<3 years of age

3-6 years of age

> 6 years of age

OR

Date or age unknown

22. History of joint bleeds prior to first beginning continuous prophylaxis or prophylaxis for menstrual bleeding (check one):

Fewer than 2 bleeds total (that is, 0 or 1 bleed total) into the large joints (ankle, knee, hip, elbow or shoulder)

2 or more bleeds total into the large joints (ankle, knee, hip, elbow or shoulder)

Unknown

23. Current clotting factor product used for continuous prophylaxis or prophylaxis for menstrual bleeding (check all that apply):

Advate Hemofil M Profilnine SD

Alphanate Humate-P Proplex T

AlphaNine SD Hyate:C Recombinate

Autoplex T Koate-DVI ReFacto

Bebulin VH Kogenate RiaSTAP (fibrinogen, FI)

BeneFIX Kogenate FS Wilate

Bioclate Konyne 80 Xyntha

Corifact (FXIII) Monarc-M

FEIBA NF Monoclate-P Unknown

FEIBA VH Immuno Mononine Other, specify ____________

Fibrogammin P (FXIII) NovoSeven (FVIIa)

Helixate Novoseven RT (FVIIa)

Helixate FS Novo13 (rXIII-A2)

24. Current prescribed clotting factor dose for continuous prophylaxis or prophylaxis for menstrual bleeding:

Dose 1: ,. Units or mg/dose

Dose 2: ,. Units or mg/dose N/A- no second dose

33. Current prescribed infusion frequency for continuous prophylaxis or prophylaxis for menstrual bleeding:

Frequency for Dose 1: . time(s)/week

OR . time(s)/month Unknown

Frequency for Dose 2: . time(s)/week

OR . time(s)/month Unknown

N/A- no second dose

34. Approximate percent of doses for continuous prophylaxis or prophylaxis for menstrual bleeding missed in the last 12 months:

<10% >50%

10-20% Unknown

21-50%

35. Treatment product(s) used since the last UDC visit (if applicable; otherwise, in the last 12 months) (check all that apply):

Advate Konyne 80

Alphanate Monarc-M

AlphaNine SD Monoclate-P

Autoplex T Mononine

Amicar Syrup (Aminocaproic acid) NovoSeven (FVIIa)

Amicar Tablet (Aminocaproic acid) Novoseven RT (FVIIa)

Bebulin VH Novo13 (rXIII-A2)

BeneFIX Packed RBCs

Bioclate Platelets

FEIBA VH Immuno Profilnine SD

Corifact (FXIII) Proplex T

Cryoprecipitated AHF (Cryoprecipitate) Recombinate

DDVAP (desmopressin IV or SQ) ReFacto

FEIBA NF RiaSTAP (fibrinogen, FI)

Fibrin glue (Tissell, Artiss) Stimate (Nasal desmopressin)

Fibrogammin P (FXIII) Topical thrombin (Evithrom, Thrombin-JMI)

Fresh-frozen plasma Tranexamic acid (Cyclokapron, Lysteda)

Helixate Whole blood

Helixate FS Wilate

Hemofil M Xyntha

Humate-P

Hyate:C None (skip to #38)

Koate-DVI Unknown

Kogenate Other, specify ____________

36. Has the patient experienced an anaphylactic or allergic reaction to clotting factor concentrate since the last UDC visit (if applicable; otherwise, in the last 12 months)?

Yes/No (skip to #38)/Unknown (skip to #38)/None used (skip to #38)

25. Current prescribed infusion frequency for continuous prophylaxis or prophylaxis for menstrual bleeding:

Frequency for Dose 1: . time(s)/week

OR . time(s)/month Unknown

Frequency for Dose 2: . time(s)/week

OR . time(s)/month Unknown

N/A- no second dose

26. Approximate percent of doses for continuous prophylaxis or prophylaxis for menstrual bleeding missed in the last 12 months:

<10% >50%

10-20% Unknown

21-50%

27. Since the last surveillance visit, which treatment product(s) has the patient used? (check all that apply)

Advate Konyne 80

Alphanate Monarc-M

AlphaNine SD Monoclate-P

Autoplex T Mononine

Amicar Syrup (Aminocaproic acid) NovoSeven (FVIIa)

Amicar Tablet (Aminocaproic acid) Novoseven RT (FVIIa)

Bebulin VH Novo13 (rXIII-A2)

BeneFIX Packed RBCs

Bioclate Platelets

FEIBA VH Immuno Profilnine SD

Corifact (FXIII) Proplex T

Cryoprecipitated AHF (Cryoprecipitate) Recombinate

DDVAP (desmopressin IV or SQ) ReFacto

FEIBA NF RiaSTAP (fibrinogen, FI)

Fibrin glue (Tissell, Artiss) Stimate (Nasal desmopressin)

Fibrogammin P (FXIII) Topical thrombin (Evithrom, Thrombin-JMI)

Fresh-frozen plasma Tranexamic acid (Cyclokapron, Lysteda)

Helixate Whole blood

Helixate FS Wilate

Hemofil M Xyntha

Humate-P

Hyate:C None (skip to #38)

Koate-DVI Unknown

Kogenate Other, specify ____________

28. Has the patient experienced an anaphylactic or allergic reaction to clotting factor concentrate since the last UDC visit (if applicable; otherwise, in the last 12 months)?

Yes/No (skip to #30)/Unknown (skip to #38)/None used (skip to #30)

37. If yes, to which product was this reaction attributed (check all that apply)?

Advate Hemofil M Profilnine SD

Alphanate Humate-P Proplex T

AlphaNine SD Hyate:C Recombinate

Autoplex T Koate-DVI ReFacto

Bebulin VH Kogenate RiaSTAP (fibrinogen, FI)

BeneFIX Kogenate FS Wilate

Bioclate Konyne 80 Xyntha

Corifact (FXIII) Monarc-M

FEIBA NF Monoclate-P Unknown

FEIBA VH Immuno Mononine Other, specify ____________

Fibrogammin P (FXIII) NovoSeven (FVIIa)

Helixate Novoseven RT (FVIIa)

Helixate FS Novo13 (rXIII-A2)

38. Has the patient ever had a central venous access device (CVAD) placed?

Yes/No (skip to #42)/Unknown (skip to #42)

If yes, then

39. Did the patient have a CVAD in place at any time since the last UDC visit (if applicable; otherwise, in the last 12 months)? Yes/No (skip to #42)/Unknown (skip to #42)

40. Has the patient had a CVAD complication since the last UDC visit (if applicable;

otherwise, in the last 12 months)? This includes complications from CVADs removed previous to this timeframe, such as post-thrombotic syndrome. Yes/No (skip to #42)/Unknown (skip to #42)

41. If yes, what kind of complication(s) (mark all that apply):

Bleeding Thrombosis

Infection Unknown

Mechanical Other

42. Does the patient have a history of intracranial hemorrhage (ICH)?

Yes/No (skip to #49)/Unknown (skip to #49)

43. How many ICHs has the patient ever experienced?

__ __ Number/Unknown

44. Please provide the date or year of occurrence for each ICH.

ICH#1: Date/Date unknown ICH#2: Date/Date unknown ICH#3: Date/Date unknown

For ICH(s) that have occurred since the last UDC visit (if applicable; otherwise, in the last 12 months), complete the following for each:

29. If yes, to which product was this reaction attributed (check all that apply)?

Advate Hemofil M Profilnine SD

Alphanate Humate-P Proplex T

AlphaNine SD Hyate:C Recombinate

Autoplex T Koate-DVI ReFacto

Bebulin VH Kogenate RiaSTAP (fibrinogen, FI)

BeneFIX Kogenate FS Wilate

Bioclate Konyne 80 Xyntha

Corifact (FXIII) Monarc-M

FEIBA NF Monoclate-P Unknown

FEIBA VH Immuno Mononine Other, specify ____________

Fibrogammin P (FXIII) NovoSeven (FVIIa)

Helixate Novoseven RT (FVIIa)

Helixate FS Novo13 (rXIII-A2)

30. Since the last surveillance visit, has the patient had a central venous access device (CVAD) in place at any time?

Yes/No/Unknown

31. Since the last surveillance visit, has the patient had a CVAD complication? This includes complications from CVADs removed previous to the last surveillance visit such as post-thrombotic syndrome.

Yes/No (Skip to #33)/Unknown (Skip to #33)

32. If yes, what kind of complication(s) (mark all that apply)?

Bleeding Thrombosis

Infection Unknown

Mechanical Other

33. Since the last surveillance visit, has the patient had an intracranial hemorrhage (ICH)?

Yes/No (Skip to #39)/Unknown (Skip to #39)

If yes, then

34. Since the last surveillance visit, how many ICHs has the patient experienced?

__ __ Number/Unknown

For ICH(s) that have occurred since the last surveillance visit, complete the following for each:

45. Date of occurrence:

ICH#i:

ICH#ii:

ICH#iii:

46. Was this ICH preceded by an episode of head trauma?

ICH#i: Yes/No/Unknown ICH#ii: Yes/No/Unknown ICH#iii: Yes/No/Unknown

47. Was the patient on continuous prophylaxis when the ICH occurred?

ICH#i: Yes/No/Unknown ICH#ii: Yes/No/Unknown ICH#iii: Yes/No/Unknown

48. When was the last infusion of factor given prior to onset of the ICH?

ICH#i: __ __ Days/ hours/ minutes More than 7 days Unknown

ICH#ii: __ __ Days/ hours/ minutes More than 7 days Unknown

ICH#iii: __ __ Days/ hours/ minutes More than 7 days Unknown

Patients <2 years of age only; otherwise skip to #52.

49. Did the patient undergo head imaging within 30 days of birth?

Yes/No (skip to #51)/Unknown (skip to #51)

50. If yes, what type of imaging was done (mark all that apply)?

CT (computed tomography) Other

MRI (magnetic resonance imaging) Imaging type unknown

US (ultrasound)

51. Other than ICH, at what site(s) did the patient experience bleeding within 30 days of birth (mark all that apply and indicate what the bleed was associated with or if spontaneous: mark spontaneous. See definitions for more complete instructions):

Bleed Sites Bleed was associated with:

Gastrointestinal Associated With Circumcision Thrombocytopenia

Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Lancet stick Other

Surgery Spontaneous

Genitourinary, Associated With Circumcision Thrombocytopenia

Hematuria Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Lancet stick Other

Surgery Spontaneous

35. Date of occurrence:

ICH#i:

ICH#ii:

ICH#iii:

36. Was this ICH preceded by an episode of head trauma?

ICH#i: Yes/No/Unknown ICH#ii: Yes/No/Unknown ICH#iii: Yes/No/Unknown

37. Was the patient on continuous prophylaxis when the ICH occurred?

ICH#i: Yes/No/Unknown ICH#ii: Yes/No/Unknown ICH#iii: Yes/No/Unknown

38. When was the last infusion of factor given prior to onset of the ICH?

ICH#i: __ __ Days/ hours/ minutes More than 7 days Unknown

ICH#ii: __ __ Days/ hours/ minutes More than 7 days Unknown

ICH#iii: __ __ Days/ hours/ minutes More than 7 days Unknown

Bleed Sites Bleed was associated with:

Genitourinary, Associated With Circumcision Thrombocytopenia

Other Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Lancet stick Other

Surgery Spontaneous

Head- Extracranial Associated With Circumcision Thrombocytopenia

Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Joint Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Muscle Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Nasal Mucosa Associated With Circumcision Thrombocytopenia

(including Epistaxis) Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Oral Associated With Circumcision Thrombocytopenia

Delivery Trauma

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Soft tissue Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Spine Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Umbilicus Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

Other Site Associated With Circumcision Thrombocytopenia

Dental procedure Venipuncture

Iatrogenic Other med procedure

Injection site

None

52. Does the patient have a history of joint bleeds ever? Yes/No (skip to #56)/Unknown (skip to #56)

53. If yes, Date or age at first joint bleed:

Date: MM/DD/YYYY

OR

Age: Days/ mos/ years (check one) or Approximate age (if specific age unknown):

<3 years of age

3-6 years of age

> 6 years of age

OR

Date or age unknown

54. If yes, indicate which joints have a history of bleeds ever and the cumulative number of bleeds into each:

Ankle, left #bleeds: 1-3 4-19 >/=20 Unknown

Ankle, right #bleeds: 1-3 4-19 >/=20 Unknown

Elbow, left #bleeds: 1-3 4-19 >/=20 Unknown

Elbow, right #bleeds: 1-3 4-19 >/=20 Unknown

Hip, left #bleeds: 1-3 4-19 >/=20 Unknown

Hip, right #bleeds: 1-3 4-19 >/=20 Unknown

Knee, left #bleeds: 1-3 4-19 >/=20 Unknown

Knee, right #bleeds: 1-3 4-19 >/=20 Unknown

Shoulder, left #bleeds: 1-3 4-19 >/=20 Unknown

Shoulder, right #bleeds: 1-3 4-19 >/=20 Unknown

55. Method of ascertainment (mark all that apply):

Paper logs Medical Chart

Electronic logs Other

Factor Dispensing Records Unknown

Routine Patient contact (non-contemporaneous patient verbal report)

56. How many treated bleeding events has the patient had since the last UDC visit (if applicable; otherwise, in the last 12 months)?

__ __ __ Number/Unknown

57. Method of ascertainment (mark all that apply):

Paper logs Medical Chart

Electronic logs Other

Factor Dispensing Records Unknown

Routine Patient contact (non-contemporaneous patient verbal report)

39. Since the last surveillance visit, has the patient experienced any joint bleeds?

Yes/No (Skip to #44)/Unknown (Skip to #44)

If yes,

40. Since the last surveillance visit, has the patient experienced his/her first joint bleed ever?

Yes/No (Skip to #44)/Unknown (Skip to #44)

41. If yes, Date or age at first joint bleed:

Date: MM/DD/YYYY

OR

Age: Days/ mos/ years (check one) or Approximate age (if specific age unknown):

<3 years of age

3-6 years of age

> 6 years of age

OR

Date or age unknown

42. Indicate which joints have experienced bleeds since the last surveillance visit and the total number of bleeds into each joint since the last surveillance visit:

Location of Bleed Number of Bleeds

Ankle, left __ __ bleeds # unknown

Ankle, right __ __ bleeds # unknown

Elbow, left __ __ bleeds # unknown

Elbow, right __ __ bleeds # unknown

Hip, left __ __ bleeds # unknown

Hip, right __ __ bleeds # unknown

Knee, left __ __ bleeds # unknown

Knee, right __ __ bleeds # unknown

Shoulder, left __ __ bleeds # unknown

Shoulder, right __ __ bleeds # unknown

43. Method of ascertainment (mark all that apply):

Paper logs Medical Chart

Electronic logs Other

Factor Dispensing Records Unknown

Routine Patient contact (non-contemporaneous patient verbal report)

44. Since the last surveillance visit, how many treated bleeding events has the patient had?

__ __ __ Number/Unknown

45. Method of ascertainment (mark all that apply):

Paper logs Medical Chart

Electronic logs Other

Factor Dispensing Records Unknown

Routine Patient contact (non-contemporaneous patient verbal report)

58. Other than ICH and joint bleeds, at what site(s) has the patient experienced bleeding in excess of that expected for a person without a bleeding disorder since the last UDC visit (if applicable; otherwise, in the last 12 months)? Mark all that apply and indicate what the bleed was associated with or if spontaneous: mark spontaneous. See definitions for more complete instructions):

Bleed Sites Bleed was associated with:

Gastrointestinal Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Genitourinary, Associated With Circumcision Surgery

Hematuria Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Inject ion site Other med procedure

Lancet stick

Other Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Inject ion site Other med procedure

Lancet stick

Head- Extracranial Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

46. Other than ICH and joint bleeds, since the last surveillance visit, at what site(s) has the patient experienced bleeding in excess of that expected for a person without a bleeding disorder? Mark all that apply and what the bleed was associated with or if spontaneous:

mark spontaneous. See definitions for more complete instructions.

Gastrointestinal Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Hematuria Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Inject ion site Other med procedure

Lancet stick

Other Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Inject ion site Other med procedure

Lancet stick

Head- Extracranial Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Joint Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Muscle Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Nasal Mucosa Associated With Circumcision Surgery

(including Epistaxis) Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Oral Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Soft tissue Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Bleed Sites Bleed was associated with:

Joint Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Muscle Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Nasal Mucosa Associated With Circumcision Surgery

(including Epistaxis) Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Oral Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Soft tissue Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Spine Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Other Site Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

59. Does the patient have a history of any invasive joint procedure(s)?

Yes/No (skip to #61)/Unknown (skip to #61)

60. If yes, mark all procedures performed and the joint(s) on which each was performed:

Ankle Elbow Hip Knee Shoulder left right left right left right left right left right

Synovectomy, arthroscopic open radioisotopic type unknown

Surgical fusion/ arthrodesis

Joint replace-ment/arthroplasty

Other invasive joint procedure

Spine Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

Menses Other

Post-partum Spontaneous

Other Site Associated With Circumcision Surgery

Delivery Thrombocytopenia

Dental procedure Trauma

Iatrogenic Venipuncture

Injection site Other med procedure

Lancet stick

47. Since the last surveillance visit, has the patient had an invasive joint procedure due to his/her bleeding disorder? Yes/No (Skip to #49)/Unknown (Skip to #49)

48. If yes, mark all procedures performed since the last surveillance visit and the joint(s) on which each was performed:

Ankle Elbow Hip Knee Shoulder left right left right left right left right left right arthroscopic open radioisotopic type unknown

Surgical fusion/ arthrodesis

Joint replace-ment/arthroplasty

Other invasive joint procedure

61. Check the statement which best describes how pain, loss of motion or weakness due to joint disease affects the patient’s current overall activity level:

Unrestricted school or work and unrestricted recreational activities

Unrestricted school or work with limited recreational activity levels

Limited school or work and limited recreational activity levels

Limited school or work, limited recreational activity levels, and limited self-care activity levels

Requires assistance from another person for school or work or self-care, and unable to participate in recreation

Unknown

62. In the last 12 months, has the patient experienced chronic pain related to his/her bleeding disorder? Yes/No (skip to #66)/Unknown (skip to #66)

63. If yes, about how often in the last 12 months did the patient experience chronic pain related to his/her bleeding disorder?

Every day/Most days/Some days/Unknown

64. In the last 12 months, has the patient been prescribed or used opioids for the treatment of chronic pain related to his/her bleeding disorder in the outpatient setting? Yes/No (skip to #66)/Unknown (skip to #66)

65. If yes, about how often in the last 12 months did the patient use opioids for chronic pain related to his/her bleeding disorder?

Every day/Most days/Some days/Never/Unknown

66. In the last 12 months, has the patient visited a hospital emergency room for a bleed or other complication of his/her bleeding disorder?

Yes/No (skip to #68)/Unknown (skip to #68)

67. If yes, how many emergency room visits did the patient have due to his/her bleeding disorder in the last 12 months?

__ __ (Number)/Unknown

68. In the last 12 months, has the patient been admitted to a hospital as an inpatient due to a bleed or other complication of his/her bleeding disorder?

Yes/No (skip to #71)/Unknown (skip to #71)

69. If yes, how many inpatient admissions did the patient have due to his/her bleeding disorder in the last 12 months?

__ __ (Number)/Unknown

70. How many nights total did the patient spend as an inpatient due to his/her bleeding disorder in the last 12 months?

__ __ (Number nights)/Unknown

71. In the last 12 months, how many days has the patient missed from school or work due to his/her bleeding disorder?

__ __ __.__ __ (Number)/Unknown/NA

49. Check the statement which best describes how pain, loss of motion or weakness due to joint disease affects the patient’s current overall activity level:

Unrestricted school or work and unrestricted recreational activities

Unrestricted school or work with limited recreational activity levels

Limited school or work and limited recreational activity levels

Limited school or work, limited recreational activity levels, and limited self-care activity levels

Requires assistance from another person for school or work or self-care, and unable to participate in recreation

Unknown

50. Since the last surveillance visit, has the patient experienced chronic pain related to his/her bleeding disorder? Yes/No (skip to #54)/Unknown (skip to #54)

51. If yes, since the last surveillance visit, about how often has the patient experienced chronic pain related to his/her bleeding disorder?

Every day/Most days/Some days/Unknown

52. Since the last surveillance visit, has the patient been prescribed or used opioids for the treatment of chronic pain related to his/her bleeding disorder in the outpatient setting?

Yes/No (skip to #54)/Unknown (skip to #54)

53. If yes, since the last surveillance visit, about how often has the patient used opioids for chronic pain related to his/her bleeding disorder?

Every day/Most days/Some days/Never/Unknown

54. Since the last surveillance visit, has the patient visited a hospital emergency room for a bleed or other complication of his/her bleeding disorder?

Yes/No (skip to #56)/Unknown (skip to #56)

55. If yes, since the last surveillance visit, how many emergency room visits has the patient had due to his/her bleeding disorder?

__ __ (Number)/Unknown

56. Since the last surveillance visit, has the patient been admitted to a hospital as an inpatient due to a bleed or other complication of his/her bleeding disorder?

Yes/No (skip to #59)/Unknown (skip to #59)

57. If yes, since the last surveillance visit, how many inpatient admissions has the patient had due to his/her bleeding disorder?

__ __ (Number)/Unknown

58. Since the last surveillance visit, how many nights total did the patient spend as an inpatient due to his/her bleeding disorder?

__ __ (Number nights)/Unknown

59. Since the last surveillance visit, how many days has the patient missed from school, or work due to his/her bleeding disorder?

__ __ __.__ __ (Number)/Unknown/N/A

72. Does the patient have a history of HBV (hepatitis B virus) infection (active or resolved)?

Yes/No/Unknown

ME8. Does the patient have a history of HCV infection (active or resolved)? Yes/No/Unknown

ME9. Does the patient have a history of HIV infection? Yes/No/Unknown

73. Does the patient have a history of vaccination for hepatitis A?

Yes/No (skip to #75)/Unknown (skip to #75)

74. If yes, what is the status of vaccination?

Completed basic vaccine series/Incompletely vaccinated/Unknown

75. Does the patient have a history of vaccination for hepatitis B?

Yes/No (skip to #77)/Unknown (skip to #77)

76. If yes, what is the status of vaccination?

If patient is female, skip to #80.

77. If male, has the patient undergone circumcision?

Yes/No (skip to #84)/Unknown (skip to #84)

78. Did excessive bleeding occur with the circumcision? Yes/No/Unknown

79. Was the circumcision performed under clotting factor concentrate coverage?

If patient is male, skip to #84.

80. If female, in the last 12 months, has the patient been prescribed iron replacement treatment (other than in pregnancy)? Yes/No/Unknown

81. If female, in the last 12 months has the patient experienced menstrual bleeding requiring a change in hygiene protection every 2 hours or more frequently?

82. If female, has the patient undergone a hysterectomy?

Yes/No (skip to #84)/Unknown (skip to #84)

83. If yes, then age or date hysterectomy was performed:

__ __ Age/Date/Date unknown

60. Since the last surveillance visit, has the patient received any doses of hepatitis A vaccine?

Yes/No (skip to #62)/Unknown (skip to #62)

61. If yes, what is the status of the vaccination?

62. Since the last surveillance visit, has the patient received any doses of hepatitis B vaccine?

Yes/No (skip to #64)/Unknown (skip to #64)

63. If yes, what is the status of the vaccination?

If patient is female skip to # 67.

64. If male, since the last surveillance visit, has the patient been circumcised?

Yes/No (skip to #71)/Unknown (skip to #71)

If yes then,

65. Did excessive bleeding occur with the circumcision? Yes/No/Unknown

66. Was the circumcision performed under clotting factor concentrate coverage?

If patient is male skip to # 71.

67. If female, since the last surveillance visit, has the patient been prescribed iron replacement treatment (other than in pregnancy)? Yes/No/Unknown

68. If female, since the last surveillance visit, has the patient experienced menstrual bleeding requiring a change in hygiene protection every 2 hours or more frequently?

69. If female, since the last surveillance visit, has the patient undergone a hysterectomy?

Yes/No (skip to # 71)/Unknown (skip to #71)

70. If yes, what was the age or date that the hysterectomy was performed?

__ __ Age/Date/Date unknown

84. Has the patient ever been diagnosed with any of the following conditions?

Cancer 84i. Hepatocellular carcinoma (HCC) Yes/No history of/Unknown

84ii. Leukemia (any type) Yes/No history of/Unknown

84iii. Cancer other than HCC and leukemia Yes/No history of/Unknown

Bone disease 84iv. Fracture of a bone Yes/No history of/Unknown

84v. Osteopenia Yes/No history of/Unknown

84vi. Osteoporosis Yes/No history of/Unknown

Cardiovascular disease 84vii. Acute ischemic stroke (AIS) Yes/No history of/Unknown

84viii. Atrial fibrillation Yes/No history of/Unknown

84ix. Coronary artery disease Yes/No history of/Unknown

84x. Congestive heart failure Yes/No history of/Unknown

84xi. Myocardial infarction Yes/No history of/Unknown

84xii. Transient ischemic attack (TIA) Yes/No history of/Unknown

Kidney disease 84xiii. Chronic kidney disease/CKD Yes/No history of/Unknown

84xiv. Kidney stones Yes/No history of/Unknown

(renal urolith, nephrolith, nephrolithiasis)

84xv. Nephrotic syndrome Yes/No history of/Unknown

Liver disease or failure 84xvi. Ascites Yes/No history of/Unknown

84xvii. Cirrhosis Yes/No history of/Unknown

84xviii. Hepatic fibrosis or Yes/No history of/Unknown

84xix. Splenomegaly Yes/No history of/Unknown

84xx. Varices (esophageal or gastric) Yes/No history of/Unknown

Thrombosis 84xxi. Deep vein thrombosis (DVT) Yes/No history of/Unknown

84xxii. Pulmonary embolism (PE) Yes/No history of/Unknown

Other 84xxiii. Anxiety Yes/No history of/Unknown

84xxiv. Depression Yes/No history of/Unknown

84xxv. Diabetes mellitus Yes/No history of/Unknown

(other than gestational diabetes)

84xxvi. Hypertension Yes/No history of/Unknown

84xxvii. Iron deficiency anemia Yes/No history of/Unknown

84xxviii. Pseudotumor Yes/No history of/Unknown

71. Since the last surveillance visit, has the patient been diagnosed with any of the following conditions?

Cancer 84i. Hepatocellular carcinoma (HCC) Yes/No history of/Unknown

84ii. Leukemia (any type) Yes/No history of/Unknown

84iii. Cancer other than HCC and leukemia Yes/No history of/Unknown

Bone disease 84iv. Fracture of a bone Yes/No history of/Unknown

84v. Osteopenia Yes/No history of/Unknown

84vi. Osteoporosis Yes/No history of/Unknown

Cardiovascular disease 84vii. Acute ischemic stroke (AIS) Yes/No history of/Unknown

84viii. Atrial fibrillation Yes/No history of/Unknown

84ix. Coronary artery disease Yes/No history of/Unknown

84x. Congestive heart failure Yes/No history of/Unknown

84xi. Myocardial infarction Yes/No history of/Unknown

84xii. Transient ischemic attack (TIA) Yes/No history of/Unknown

Kidney disease 84xiii. Chronic kidney disease/CKD Yes/No history of/Unknown

84xiv. Kidney stones Yes/No history of/Unknown

(renal urolith, nephrolith, nephrolithiasis)

84xv. Nephrotic syndrome Yes/No history of/Unknown

Liver disease or failure 84xvi. Ascites Yes/No history of/Unknown

84xvii. Cirrhosis Yes/No history of/Unknown

84xviii. Hepatic fibrosis or Yes/No history of/Unknown

84xix. Splenomegaly Yes/No…