International IBD Genetics Consortium Thiopurine Induced Leucopaenia Case Report Form On completion, please return to: Thiopurine Induced Leucopaenia Introduction
Please complete all boxes where indicated and in black ball point pen.
If you make a mistake please put a line through the box, initial and date and write answer to the side.
The patient identification number is the bar code on the front of the CRF. Please transcribe this on to the top of the page in each relevant section.
For study inclusion participants must meet all the major criteria and any number of the additional minor criteria. *Drug causes of leucopaenia
Antithyroid drugs (thionamides - Methimazole, Carbimazole, Propylthiouracil)
Anti-inflammatory drugs (Sulfasalazine, Nonsteroidal anti-inflammatory drugs [NSAIDs], Penicillamine)
Psychotropic drugs (Clozapine, Phenothiazines, Tricyclic and tetracyclic antidepressant)
Gastrointestinal drugs (Sulfasalazine, Histamine H2- receptor antagonists)
Cardiovascular drugs (Antiarrhythmic agents (tocainide, procainamide, flecainide), ACE inhibitors (enalapril, captopril), Propranolol, Dipyridamole, Digoxin)
Dermatologic drugs (Dapsone, Isotretinoin)
Antibacterial drugs (Macrolides including minocycline, Trimethoprim-sulfamethoxazole, Chloramphenicol, Sulfonamides, Vancomycin, Cephalosporin)
Antifungal agents (Amphotericin B, Flucytosine)
Anticonvulsants (Carbamazepine, Phenytoin, Ethosuximide, Valproate, lamotrigine)
Diuretics (Thiazides, Acetazolamide, Frusemide, Spironolactone)
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)Thiopurine Induced Leucopaenia Section 1 - Inclusion Criteria Study code 1.1 Major criteria (all must be met)
History of thiopurine exposure in the previous 7 days
Normal total white cell count and/or neutrophil count at baseline
Fall in total white cell count to ≤2.5x109/L, or reduction in neutrophil count to
Medical opinion implicating thiopurine leads to dose reduction or drug withdrawal (even if temporary)
1.2 Other risk factor(s) or potential causes for leucopaenia (see page 2)*
Symptoms suggestive of recent viral infection
1.3 Minor criteria (sum number of criteria):
Fall in total white cell count or neutrophil count within 12 months of introduction of thiopurines
White cell count and neutrophil count returns to normal range after dose reduction or drug withdrawal
Recurrence (defined as total white cell count ≤3.5x109/L or neutrophil count ≤2.0x109/L)
on re-challenge with either Azathioprine or Mercaptopurine
1.4 Number of minor criteria 1.5 Participant's eligibility Investigator sign-off Is the participant eligible to take part in the clinical trial?
If no, please give reason(s) for screen failure:
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)Thiopurine Induced Leucopaenia Section 2 - Patient Details Study code 2.1 Patient details
Weight at time of leucopaenia (or nearest estimate) kg
2.2 Ethnicity - Please tick as appropriate Black or Black British Chinese or Other Ethnic Group
Any other ethnic group (please specify)
Asian or Asian background 2.3 Participant informed consent
Date participant signed written consent form
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September2011)Thiopurine Induced Leucopaenia Section 3 - Medical History Study code 3.1 Hospital Details 3.1.1 Consultant Gastroenterologist 3.1.2 Consultant Haematologist 3.2 Other significant medical history International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)Thiopurine Induced Leucopaenia Section 4 - Diagnosis & Classification of IBD Study code 4.1 Diagnosis and classification of IBD 4.2 Smoking history
4.2.3 Maximum number of cigarettes per day
4.3 Ulcerative colitis 4.3.1 The extent of ulcerative colitis can be classified as:
E1 Ulcerative proctitis - inflammation is limited to the rectum (proximal extent of inflammation is distal to the rectosigmoid junction)
E2 Left sided UC (distal UC) - inflammation limited to a proportion of the colorectum up to the splenic flexure
E3 Extensive UC (pancolitis) - inflammation extends beyond the splenic flexure
4.3.2 Disease severity in 2 years prior to development of leucopaenia
DS0 Clinical remission. Asymptomatic; no escalation of treatment
DS1 Mild relapses - managed with oral or rectal aminosalicylates and/or rectal steroids: no oral steroids required
DS2 Moderate relapses requiring oral steroids and/or addition of immunomodulator
DS3 Severe or refractory disease requiring inpatient admission or colectomy
4.4 Crohn's disease 4.4.1 Location 4.4.2 Behaviour - the behaviour can be defined by looking at reports from Barium enema, International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September2011)Thiopurine Induced Leucopaenia Section 5 - Leucopaenia History Study code 5.1 Which thiopurine was suspected of causing leucopaenia? 5.2 Date thiopurine first commenced 5.3 Maximum dose of thiopurine in 8 weeks prior
to episode of leucopaenia 5.3.1 Date when this maximum dose of thiopurine started 5.4 Were TGN levels measured within 2 months of detecting the leucopaenia
If yes, what was the level (pmol/8 x 108 RBC)?
5.6 Leucopaenia Total white Neutrophil Haemoglobin Platelet cell count
commencing thiopurineFirst blood test demonstrating leucopaenia
(below normal range for your lab)Blood test demonstrating
lowest total white cell countBlood test demonstrating
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)Thiopurine Induced Leucopaenia Section 5 - Leucopaenia History Study code 5.7 Recovered cell counts Cell count
Best recovered total white cell count within 8
weeks of dose reduction/withdrwalBest recovered neutrophil count within 8 weeks
Time to best recovered total white cell count/neutrophil count (days)
5.8 Did the patient require hospital admission at any stage due to leucopaenia 5.9 Complications 5.10 Was the individual ever re-challenged with a thiopurine?
If yes, what was the outcome of the re-challenge?
5.11 Was a bone marrow biopsy done? 5.12 Was the patient ever treated with G-CSF?
Did the patient receive any other treatment for leucopaenia?
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September2011)Thiopurine Induced Leucopaenia Section 6 - Supplementary Information Study code 6.1 What is the individual's thiopurine methytransferase (TPMT) genotype/
activity ? 6.2 Has the individual experienced any other adverse effects attributable to azathioprine/mercaptopurine? 6.2.1 Abnormal LFTs (please give peak ALT/AST and laboratory reference range) 6.2.2 Pancreatitis (please state peak serum amylase/lipase and laboratory reference) 6.2.3 Other (please state): 6.3 Family history
Family history of thiopurine induced leucopaenia
International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)Thiopurine Induced Leucopaenia Section 7 - Other Drug History Study code 7.1 Did the patient receive steroids in the 3 months prior to recognition of leucopaenia? 7.2 Other drugs in 3 months prior to development of leucopaenia International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September2011)Thiopurine Induced Leucopaenia Section 8 - Principal Investigator Statement Study code
I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant. All entries were made either by myself or by a person under my supervision who has signed the Delegation and Signature Log.
ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF WITHOUT A SIGNED DATA QUERY FORM International IBD Genetics Consortium Thiopurine Induced Leucopaenia in IBD CRF v2.0 (20 September 2011)
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