Aglietta 2000.

Methods	RCT, 1991‐94, allocation concealed*
Participants	56 patients randomised, age 18‐77, gender m/f: 33/23, country: Italy Hodgkin's disease, biopsy proven*, untreated, stage II‐IV
Interventions	1. CT Mechlorethamine 6 mg/m², iv, d1 Vincristine 1.4 mg/m², max 2.0 mg/m², iv, d1 Procarbazine 100 mg/m², po, d1‐7 Prednisone 40 mg/m², po, d1‐7 Doxorubicin 25 mg/m², iv, d15 Bleomycin 10 mg/m², iv, d15 Vinblastine 6 mg/m², iv, d15 Dacarbazine 375 mg/m², iv, d15 this regimen was repeated every 28 days times 6 2. GM‐CSF (5 µg /kg/day s.c. prior to each chemotherapy cycle), used d7‐4 before first cycle, d8‐11 and d22‐25 each subsequent cycle 3. no placebo given 4. no AB prophylaxis given*
Outcomes	primary endpoints: adherence to the planned delivery rate of planned CT secondary endpoints: nadir neutrophil counts, total duration of neutropenia, total number of days of antibiotic or antifungal treatment, additional outcomes: adverse effects, tumour response
Notes	funding: Italian Association for Cancer Research and Novartis Farma, S.p.A., Italy
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate