Allocation and treatment received

Assigned population → allocated arms → treatment received or not received

Flow diagram

Allocation and treatment receivedAllocation and treatment receivedF1.S1Assigned populationF1.S2Allocated to arm AF1.S3Allocated to arm BF1.S4Received assigned strategy AF1.S5Received assigned strategy BF1.S6Did not receive assignedstrategy AF1.S7Did not receive assignedstrategy BF1.N1Treatment receipt reasonsArmStatusReasonCountObservationcutoffArm AArm BF1.N2Assignment and receipt definitions

Steps

Assigned population

Define unique participants assigned at cutoff.

Allocated to arm A

Rename for the assigned strategy.

Allocated to arm B

Remove or duplicate arms to match the study.

Received assigned strategy A

Define treatment receipt and minimum exposure if applicable.

Received assigned strategy B

Define treatment receipt consistently.

Did not receive assigned strategy A

Record nonreceipt at cutoff.

Did not receive assigned strategy B

Record nonreceipt at cutoff.

Tables and supporting information

Treatment receipt reasons

Treatment receipt reasonsArmStatusReasonCountObservationcutoffArm AArm B

Crossovers do not change original assignment; record received treatment separately.

Assignment and receipt definitions

Define how pending treatment at cutoff is classified. Update count rules when adding arms.

Sources