Dosing and toxicity assessment windows

Specify schedules toxicity and activity

Define toxicity and activity ascertainment and their windows before enrollment. Delayed outcomes and dose modifications affect decision readiness; missing follow-up must not be mistaken for absence of toxicity.

Flow diagram

Dosing and toxicity assessment windowsF1.S1Specify permissible dose levelsF1.S2Define toxicity and activityendpointsF1.S3Define assessment windowsF1.S4Handle incomplete follow-upF1.S5Track dose modifications and safetyF1.N1Dose and assessment specificationElementDefinitionWindowAssessmentAuthorityDose levelsDLTActivityDelayedtoxicityIncompletefollow-upF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowDosing and toxicity assessmentwindowsF1.S999 End flowEnd flow

Steps

Specify permissible dose levels

Record dose, schedule and escalation constraints from the protocol.

Define toxicity and activity endpoints

Specify dose-limiting toxicity criteria, attribution and activity measures.

Define assessment windows

Record follow-up durations, delayed toxicity and relevant exposure.

Handle incomplete follow-up

Prespecify waiting, accrual holds or a justified time-to-event method.

Track dose modifications and safety

Document interruptions, reductions and review triggers.

Dosing and toxicity assessment windows

End flow

Tables and supporting information

Dose and assessment specification

Dose and assessment specificationElementDefinitionWindowAssessmentAuthorityDose levelsDLTActivityDelayedtoxicityIncompletefollow-up

Enter protocol-approved definitions; leave doses and thresholds blank.

Assumptions and rationale

Pending toxicity is not equivalent to absence of toxicity, and activity and tolerability answer different questions.

Method and protocol evidence

Attach the protocol, methodological sources and versioned software specification supporting these decisions. Record citations and provenance; do not enter participant identifiers.

Sources