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Of note, relative to other lymphomas, a higher than anticipated incidence of Hodgkin's disease was seen in our series.
The most common AEs were primarily gastrointestinal and asthenia, and the AEs observed did not lead to a higher than anticipated incidence of treatment-related withdrawal.
The phase II study of this regimen was conducted in previously untreated nonsquamous NSCLC (clinicaltrials.gov identifier: NCT00794417) and results will be reported separately, but it is noted that the study was discontinued early owing to a higher than anticipated incidence of RPLS.
With a sample of at least 6500 patients, we will have over 80% power to detect at least a 20% relative risk reduction in AKI with aspirin versus placebo should it exist (anticipated incidence of AKI of ∼12% in the placebo group, two-tailed α=0.05, χ test; table 1).
To calculate required sample size for adequate power, we anticipated at least a 10% greater reduction in proliferation index (Ki-67) between the EXE COXIB and EXE arms in COX2-expressing cases (anticipated incidence of COX-2 expression being 60% (Bundred et al, 2010) of all cases).
We will have over 90% power to detect at least a 10% RRR in AKI with methylprednisolone versus placebo should it exist (anticipated incidence of AKI in the placebo group in SIRS, which has enrolled a group at high risk of postoperative complications, is about 38%, two-tailed α 0.05, χ test; table 1).
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Based on the prevalence to incidence ratio of 2.4 observed in the Roddy study, we anticipated an incidence of 5 per 100 WY among placebo users in our trial.
As would be anticipated, the incidence of non-CNS pathology is dramatically reduced in this model.
As anticipated, the incidence of neutropaenia was higher than that observed with single-agent dacarbazine, affecting 10 patients and in 9 of these, the severity was ⩾grade 3. Two patients died within 30 days of receiving study drug.
Challenges experienced were high baseline HIV-prevalence, lower than anticipated HIV-incidence and difficulties retaining participants.
Based on our pilot data, we anticipate the incidence of the primary composite outcome to be 35%% pre-EASE (cohorts (i) and (iii)) [ 55– 55].
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Justyna Jupowicz-Kozak
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