Comments (1)
Issue has been resolved in v1.0.2 by enabling the user to determine the type of outcome in the OutcomeDist object. If the user specify "event", the observation could be censored if a Design object is define. The lenght of the outcome.type argument must corresponds to the number of endpoints.
Example:
# Outcome parameters
median.time.placebo = 6
rate.placebo = log(2)/median.time.placebo
outcome.placebo = parameters(rate = rate.placebo)
median.time.treatment = 9
rate.treatment = log(2)/median.time.treatment
outcome.treatment = parameters(rate = rate.treatment)
# Dropout parameters
dropout.par = parameters(rate = 0.0115)
# Data model
case.study1.data.model = DataModel() +
OutcomeDist(outcome.dist = "ExpoDist", outcome.type = "event") +
SampleSize(350) +
Design(enroll.period = 9,
study.duration = 21,
enroll.dist = "UniformDist",
dropout.dist = "ExpoDist",
dropout.dist.par = dropout.par) +
Sample(id = "Placebo",
outcome.par = parameters(outcome.placebo)) +
Sample(id = "Treatment",
outcome.par = parameters(outcome.treatment))
# Analysis model
case.study1.analysis.model = AnalysisModel() +
Test(id = "Placebo vs treatment",
samples = samples("Placebo", "Treatment"),
method = "LogrankTest") +
Statistic(id = "Events Placebo",
samples = samples("Placebo"),
method = "EventCountStat") +
Statistic(id = "Events Treatment",
samples = samples("Treatment"),
method = "EventCountStat") +
Statistic(id = "Patients Placebo",
samples = samples("Placebo"),
method = "PatientCountStat") +
Statistic(id = "Patients Treatment",
samples = samples("Treatment"),
method = "PatientCountStat")
# Evaluation model
case.study1.evaluation.model = EvaluationModel() +
Criterion(id = "Marginal power",
method = "MarginalPower",
tests = tests("Placebo vs treatment"),
labels = c("Placebo vs treatment"),
par = parameters(alpha = 0.025)) +
Criterion(id = "Mean Events Placebo",
method = "MeanSumm",
statistics = statistics("Events Placebo"),
labels = c("Mean Events")) +
Criterion(id = "Mean Events Treatment ",
method = "MeanSumm",
statistics = statistics("Events Treatment"),
labels = c("Mean Events")) +
Criterion(id = "Mean Patients Placebo",
method = "MeanSumm",
statistics = statistics("Patients Placebo"),
labels = c("Mean Patients")) +
Criterion(id = "Mean Patients Treatment",
method = "MeanSumm",
statistics = statistics("Patients Treatment"),
labels = c("Mean Patients"))
# Simulation Parameters
case.study1.sim.parameters = SimParameters(n.sims = 1000,
proc.load = "full",
seed = 42938001)
# Perform clinical scenario evaluation
case.study1.results = CSE(case.study1.data.model,
case.study1.analysis.model,
case.study1.evaluation.model,
case.study1.sim.parameters)
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Related Issues (8)
- Marginal power calculation with sample size higher than 1000 in survival HOT 2
- Anova/Ancova HOT 4
- Enrollment distribution and mean events
- Integer overflow HOT 3
- [Question] Could you, please, cross-validate the calculation gMCP vs. Mediana in this scenario? HOT 2
- Restricted mean survival time HOT 1
- Survival models result in simular number of events per arm regardless of rate HOT 3
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