Vora 2006

Methods	Prospective cohort study (originally developed as a RCT; a selected group of patients was followed up for hepatic late adverse effects)
Participants	N of patients original cohort: nm; N of patients described study group: 43 with splenomegaly during chemotherapy; N of patients study group of interest: 43; N of patients with liver function tests: 43 Tumour: lymphoblastic leukaemia; Time period diagnosis/treatment: 1997‐2002; Age at diagnosis: 1.0‐18.0 yr; Age at follow‐up: nm; F/M%: nm; BMI: nm N of patients hepatitis virus infection: nm N of patients acute liver disease: 0/43 (0.0%) abnormal liver function tests <1 yr after end chemotherapy Follow‐up duration: mean 3.3 (0.0‐5.4) yr after end of treatment; Completion of follow‐up: 100%
Interventions	N of patients chemotherapy: 43/43 (100%); Chemotherapy type: 6‐thioguanine, 6‐mercaptopurine, vincristine, methotrexate, L‐asparaginase, prednisolone, dexamethasone (other chemotherapeutic regimens not mentioned); Chemotherapy dose: 40 mg/m2/day 6‐thioguanine, 75 mg/m2/day 6‐mercaptopurine (dose other chemotherapeutic regimens not mentioned) N of patients radiotherapy involving the liver: nm; Radiotherapy field: nm; Radiotherapy dose: nm N of patients hepatectomy: nm N of patients BMT: nm N of patients blood transfusion: nm
Outcomes	Method of detection of hepatic late adverse effects: aminotransferases, liver biopsy (n=10) (frequency of testing nm) Definition of hepatic late adverse effects: elevated aminotransferases N of patients hepatic late adverse effects at end of follow‐up: aminotransferases: 6/43 (14.0%); liver biopsy: 10/10 (100%) portal fibrosis or nodular regenerative hyperplasia Risk factors: not evaluated
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Representative study group	Unclear risk	Unclear if described study group consisted of more than 90% of the original cohort or if it was a random sample with respect to cancer treatment
Complete follow‐up assessment	Low risk	Outcome was assessed for more than 90% of the study group of interest
Blinded outcome assessor	Unclear risk	Unclear if outcome assessors were blinded to the investigated determinant
Well defined study group	High risk	Number of patients with hepatitis virus infection was not mentioned
Well defined follow‐up	Low risk	Length of follow‐up was mentioned
Well defined outcome	High risk	Outcome definition was not objective and precise