SafetyWindowSize-class: Safety window length based on cohort size. This class is used...

Description Details Slots Examples

Description

patientGap is to be used as follows. If for example, the cohort size is 4 and we want to specify three time intervals between these four patients: The interval between the 1st and 2nd patient = 7 units of time , the interval between the 2nd and 3rd patient = 5 units of time, the interval between the 3rd and 4th patient = 3 units of time, then we specify patientGap to be c(7,5,3). Sometimes, we only think the interval between the 1st and 2nd patient should be increased for the safety consideration , and the rest time intervals can be the same, whatever the cohort size is, then we specify patientGap to be c(7,3). The package will automatically repeat the last element of the vector for the rest time intervals.

Details

Note that sizeIntervals is to be read as follows. For instance, When we want to change the patientGap based on the cohort size, i.e. the time interval between the 1st and 2nd patient = 9 units of time and the rest time intervals are 5 units of time when the cohort size is equal or larger than 4. And the time interval between the 1st and 2nd patient = 7 units of time and the rest time intervals are 3 units of time when the cohort size is smaller than 4, then we specify sizeIntervals to be c(0, 4). That means, the right bound of the intervals are exclusive to the interval, and the last interval goes from the last value until infinity.

Slots

patientGap

Observed period of the previous patient before the next patient can be dosed

sizeIntervals

An integer vector with the left bounds of the relevant cohort size intervals

patientFollow

The period of time that each patient in the cohort needs to be followed before the next cohort open

patientFollowMin

At least one patient in the cohort needs to be followed at the minimal follow up time

Examples

1
2
3
4
5
6
7
8
# As example, here is the rule for: 
#   having patientGap as (7,3,3,3,...) for cohort size <4
#   and having patientGap as (9,5,5,5...) for cohort size >=4

myWindowLength <- SafetyWindowSize(patientGap = list(c(7,3),c(9,5)),
                                   sizeIntervals = c(1,4),
                                   patientFollow = 7,
                                   patientFollowMin = 14)

0liver0815/onc-crmpack-test documentation built on Feb. 19, 2022, 12:25 a.m.