Henke 2003.
Methods | randomized controlled trial, placebo‐controlled | |
Participants | n = 351, head and neck cancer (advanced, stage III, IV); concomitant treatment: radiotherapy | |
Interventions | drug = Epoetin beta dose = 300 IU/kg sc TIW hb‐target = 12‐14 g/dL (women), 13‐15 g/dL (men) planned ESA duration = during radiotherapy |
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Outcomes | Primary: efficacy of radiotherapy, measured as local progression free survival; secondary: survival, progression free survival, Hb, safety, tolerability | |
Notes | study number = 58106 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Each center had numbered packages per stratum, once randomized the lowest number had to be assigned. There was a randomization list only the statistics center had access to. In addition, there were sealed envelopes for emergencies. |
Allocation concealment? | Low risk | coded drug packs of identical appearance |