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* |
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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 |