Introduction

Discontinuation models the dropout of patients on study treatment.

Notes

Specification of discontinuations can occur using sentences or using visit action discontinue. If visit action table is used in the specification, then the ability to declare discontinuation specification using sentences is ignored.

If different discontinuation rates should be modeled per region or study phase, visit action discontinue must be used.

If using a visit action table, and a global discontinuation rate is needed, the user will need to determine the percentage drop they would like to see across the entire visit schedule and then divide that evenly across all visits.

• To compute this, the user can use this formula:
  per_visit_rate = 1 - ((1 - global_rate) ^ (1/n_visit))

• If the global rate is 5% and there are 15 visits, the formula will read:
  per_visit_rate = 1 - (0.95 ^ (1/15)) = 0.0034 = 0.34%

Discontinuation specification using sentences

Syntax

In cohort [cohort1, cohort 2, … and cohort n], treatment arm [treatment arm 1, treatment arm 2, … and treatment arm n], on titration level [titration level 1, titration level 2, … and titration level n] at visit [visit 1, visit 2, … and visit n], the dropout rate is [dropout rate in percent]%.

Declaring a global dropout rate evenly spread across all visits: ‘Discontinuation rate for the study is 5% spread across all visits.’

Example

In cohort CO_01, treatment arm TA, on titration level DL_L, at visit V2, V3 and V5, the dropout rate is 1%.

Discontinuation events

Aliases

Dropout events.

Definition

Defines at which visit and for which patients a discontinuation can occur. Discontinuation events are characterized by

• cohort,

• treatment arm,

• titration level and

• visit.

In forecast calculations with RTSM data extract, if a discontinuation event is specified in 4C Supply® then the corresponding dropout rate will be considered in the forecast calculation for existing and forecasted patients.

Rules

Cohorts specified for discontinuation events must match a cohort specified in the cohorts table. If an invalid entry is made, no error will be raised, but the discontinuation specification will apply to all cohorts.

Treatment arms specified for discontinuation events must match a treatment specified in the randomization specification. If an invalid entry is made, no error will be raised, but the discontinuation specification will apply to all treatment arms.

Titration levels specified for discontinuation events must match a titration level specified in the titration specification. If an invalid entry is made, no error will be raised, but the discontinuation specification will apply to all titration levels.

Visits specified for discontinuation events must match a visit code specified in the visit schedule. If an invalid entry is made, no error will be raised, but the discontinuation specification will apply to all visits.

In forecast calculations with RTSM data extract, if the dropout events specified in 4C Supply® do not match the real future dropout events (for which the RTSM extract often contains valuable data), the demand and supply forecasts can be incorrect.

Dropout rate

Definition

Defines the percentage of patients forecasted to discontinue at a dropout event.

In forecast calculations with RTSM data extract, the dropout rate specified in 4C Supply® is the assumed dropout rate of existing and forecasted patients which is considered in the forecast calculation.

Rules

Must be a valid percentage value. If an invalid entry is made, an error with the following message is shown:

Must be a value between 0% and 100%. If an out-of-range entry is made, an error with the following message is shown:

If the dropout rate specified in 4C Supply® does not match the real future dropout rate (for which the RTSM extract often contains valuable data), the demand and supply forecasts can be incorrect.