PEXIVAS CDA Form
Version 2.1, February 27th 2014
Confidential once completed
PEXIVAS – COMBINED DAMAGE ASSESSMENT (CDA) INDEX FORM 20
Participant Initials:
iiFii iMi iiLii
Evaluation Date:
Study ID:
Ii ii I i ii i
Investigator:
iDi iDi / Mi iMi / Yii iYii iYii iYii
Please select Assessment Point below:
Baseline
Assessment
Week 12
Assessment
Week 26
Assessment
Week 52
Assessment
6 monthly
Assessment
Instructions: This is for recording organ damage that has occurred in patients since the onset of vasculitis. Co-morbidity that exists
before the onset of vasculitis must not be scored. A new patient should have a CDA of zero unless he has had vasculitis for at least 6
months, and the damage has developed or become worse since the onset of vasculitis. A finding must be present for 6 months to be
scored. Damage is irreversible, and only rarely should a scored item not be carried forward. Where applicable, please include the
primary data values, in addition to marking the relevant box
Musculoskeletal
None:
No
Yes
No
Yes
Osteoporosis/vertebral collapse
Bone fracture:
Due to renal dystrophy
Due to osteoporosis
Due to both
Muscle atrophy due to glucocorticoids:
Normal strength, atrophy on exam
Weak on examination, normal ADLs
Weak and has difficulty with ADLs
Avascular necrosis
Deforming/erosive arthritis
Osteomyelitis
Skin/Membranes
None:
Alopecia
Mouth ulcers
Cutaneous scarring
Cutaneous ulcers
Striae
Gangrene with permanent tissue loss
Easy bruising
Ocular
None:
No
Proptosis
Pseudotumor
Scleral thinning
Scleral perforation
Optic nerve edema
Optic nerve atrophy
Retinal changes
Retinal artery occlusion
Retinal vein occlusion
Yes
Please circle one
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
Right
Right
Right
Right
Right
Right
Right
Right
Right
Both
Both
Both
Both
Both
Both
Both
Both
Both
PTO
ISRCTN07757494
EudraCT: 2009-013220-24
ClinicalTrials.gov: NCT00987389
Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS or return form to: PEXIVAS Office, Birmingham Clinical Trials
Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Page 1 of 5
PEXIVAS CDA Form
Version 2.1, February 27th 2014
Confidential once completed
Ocular Continued
Low vision
Diplopia
Blindness
Cataracts
Glaucoma
Orbital wall destruction
Ear
No
No
Sensorineural hearing loss
Conductive hearing loss
Tympanic membrane perforation or scarring
Tinnitus
Eustachian tube dysfunction
Auricular cartilage deformity
Cholesteatoma
Nose
Yes
Yes
Please circle one
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
Right
Right
Right
Right
Right
Right
Both
Both
Both
Both
Both
Both
None:
Please circle one
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
If Yes, Left
Right
Right
Right
Right
Right
Right
Right
Both
Both
Both
Both
Both
Both
Both
None:
No
Yes
No
Yes
No
Yes
No
Yes
Chronic rhinitis/crusting
Nasolacrimal duct obstruction
Nasal bridge collapse/saddle nose
Nasal septal perforation
Anosmia
Ageusia
Sinuses
None:
Chronic sinusitis
Neo-ossification of sinuses
Subglottic stenosis
None:
No intervention required
Intervention required
Pulmonary
None:
Irreversible loss of lung function
Fixed large airway obstruction
Pulmonary hypertension
Pulmonary fibrosis
Pulmonary embolism
Pulmonary infarction
Vena caval filter
Continuous oxygen dependency
Chronic asthma
Pleural fibrosis
Chronic breathlessness
Forced Vital Capacity (FVC) (litres)
Forced Expiratory Volume in 1 Second (FEV1) (litres)
Right Ventricular Systolic Pressure (RVSP) (mmHg)
PTO
ISRCTN07757494
EudraCT: 2009-013220-24
ClinicalTrials.gov: NCT00987389
Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS or return form to: PEXIVAS Office, Birmingham Clinical Trials
Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Page 2 of 5
PEXIVAS CDA Form
Confidential once completed
Version 2.1, February 27th 2014
Cardiac
None:
No
Yes
No
Yes
No
Yes
No
Yes
Hypertension (defined as BP 142 / 90):
Pre-HTN: SBP 130-139 or DBP 80-89
Stage I: SBP 140-149 or DBP 90-99
Stage II: SBP >149 or DBP >99
Angina
Myocardial infarction
Percutaneous coronary intervention
Coronary artery bypass graft
LV dysfunction: EF: ____ ____ %
NYHA Class I/II
NYHA Class III/IV
Third degree AV block
Valvular disease:
Specify:
Pericarditis or pericardectomy
Vascular Disease
None:
Absent pulses in 1 limb
nd
2 episode of absent pulses in 1 limb
Major vessel stenosis
Claudication > 3 months
Minor tissue loss
Major tissue loss
Subsequent major tissue loss
Deep venous thrombosis
Complicated venous thrombosis
Cartoid artery disease
Renal artery stenosis
Arterial thrombosis/occlusion
Specify:
Gastrointestinal
None:
Gut infarction/resection
Hepatic fibrosis
Mesenteric insufficiency/pancreatitis
Esophageal stricture/surgery
Chronic peritonitis
Renal
None:
Estimated/measured GFR<50%
Chronic kidney disease
End-stage renal disease
Dialysis
Renal transplant
Proteinuria:
<3g/24h
>3g/24h
PTO
ISRCTN07757494
EudraCT: 2009-013220-24
ClinicalTrials.gov: NCT00987389
Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS or return form to: PEXIVAS Office, Birmingham Clinical Trials
Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Page 3 of 5
PEXIVAS CDA Form
Confidential once completed
Version 2.1, February 27th 2014
Neurologic
None:
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Seizures
Transverse myelitis
Sensory polyneuropathy:
Mild
Moderate
Severe
Motor neuropathy (mononeuritis)
Neuropathic pain
Cerebrovascular accident
nd
2 cerebrovascular accident
Cranial nerve lesion:
Specify:
Psychiatric
None:
Cognitive impairment
Anxiety disorder due to vasculitis
Mood disorder due to vasculitis
Major pyschosis
Endocrine
None:
Diabetes insipidus
Premature ovarian failure
Azoospermia
Impaired fasting glucose
Diabetes mellitus
Hematology/Oncology
None:
Bladder cancer
Cervical cancer
Hematopoetic malignancy
Solid tumor malignancy:
Specify:
Refractory cytopenia
Myelodysplastic syndrome
Other
None:
Weight gain > 10lbs/4.4kg
Fibromyalgia
Drug-induced cystitis:
with microscopic hematuria
with gross hematuria
requiring transfusion
requiring cystectomy
Damage requiring surgical intervention:
Specify:
Medications to manage side effect s of
immunosuppressive agents
Specify:
Hypogammaglobulinemia
ISRCTN07757494
EudraCT: 2009-013220-24
ClinicalTrials.gov: NCT00987389
Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS or return form to: PEXIVAS Office, Birmingham Clinical Trials
Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Page 4 of 5
PEXIVAS CDA Form
Confidential once completed
Version 2.1, February 27th 2014
Physician Global Assessment: mark line to indicate the total burden of damage in
this patient:
NONE
0 – 1 – 2 – 3 – 4 – 5 – 6 – 7 – 8 – 9 – 10
MAXIMUM
Thank you for completing the PEXIVAS CDA Form 20. Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS, or Fax to:
0121 415 9135, or Email scanned copy to: [email protected].
ISRCTN07757494
EudraCT: 2009-013220-24
ClinicalTrials.gov: NCT00987389
Please enter data online at https://www.trials.bham.ac.uk/PEXIVAS or return form to: PEXIVAS Office, Birmingham Clinical Trials
Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
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