8/19/2019 Blood Dyscrasias Checklist_PPH2016PH026219 (1)

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Central (CTSO or PMSO) #:_________________________

Manufacture Receipt Date  (dd/mm/yyyy): CPO (or SINA) #:______PPH2016PH026219 ___________ _____/_____/________ 

Targeted Follow-up ChecklistBlood Dyscrasias and Myelosuppression

In addition to collecting routine information for this aderse eent! "lease ensure the follo#ing additional information is "roidedand/or confirmed$

Event Description:%id the "atient "resent #ith any of the follo#ing signs or sym"toms& Check all that apply

 'nemia Polycythemia 'granulocytosis

 euco"enia euocytosis Hemolytic

 *hrom+ocyto"enia Pancyto"enia anemia / hemolysis

 ,eutro"enia *hrom+ocythemia ,one of the a+oe

-ere there any sym"toms to suggest that the "atient may hae +een anemic! neutro"enic or throm+ocyto"enic +efore thesus"ect drug #as receied& (e$g$ dys"nea! fatigue! "allor! une."lained feer! +ruising! nose +leeds! +leeding gums! etc$)

  Yes (please specify)  No  nknown

-ere there any clinical sym"toms or signs associated #ith the eent& (e$g$ s"lenomegaly! lym"hadeno"athy! recurrentinfections! hemorrhaging! etc$)  Yes (please specify)  No (how was the event etecte!)

-ere any of the follo#ing diagnostic tests "erformed& Check all that applyIf yes! "lease s"ecify #hich test(s) and include reference range and "re and "ost treatment alues and dates

 om"lete +lood count () 3itamin 12 'ntinuclear anti+odies

 4erum iron 5olate 'ntineutro"hil anti+odies

 Platelet count 5erritin HI3 serology

 oom+s test/Indirect oom+s test reatinine clearance leeding time

 'ntidrug anti+ody tests ier function tests Prothrom+in time (P*)

 Partial throm+o"lastin time (P**) 4erum "rotein electro"horesis 4edimentation rate

 7rinalysis Iinternational normali8ed ratio (I,)  Iron +inding ca"acity

lood urea nitrogen 4erum creatinine ,one of the a+oe

If yes! "lease descri+e or "roide the results

 one marro# +io"sy/*re"hine agnetic resonance imaging *scanone marro# as"iration ,one of the a+oe

!atient "istory:

Has the "atient +een e."osed to to.ic drugs (e$g$! +en8ene! insecticides)! chemicals! radiation! or other su+stances (e$g$organo"hos"hates! anticonulsants! heay metals! anticoagulants! nonsteroidal antiinflammatory agents! as"irin! sulfa drugs!diuretics)&

  Yes (please escri"e)  No  nknown

%oes the "atient concurrently use any drugs that may su""ress the immune system (e$g$! chemothera"y agents! cytoto.ics)&

  Yes (please escri"e)  No  nknown

%oes the "atient hae a history of any of the follo#ing "rior to the start of the sus"ect drug& Check all that apply

 lood loss (e$g$ ;I +leeding) Pregnancy 3iral infection

 yelofi+rosis / myelodys"lastic syndrome *ransfusion of +lood ulti"le myeloma

3itamin 12 deficiency ead "oisoning etastatic cancer  

 'utoimmune disease (e$g$ 4

sarcoidosis) alnutrition ongenital dyseratosis