myCSG © |Area: ADaM| Concept: C1013 : Time to event related variables | Lesson: L101 : Time to first rescue medication |

  • Let us assume that we are working on a diabetes study, testing a particular medication against placebo
  • There can be cases where the glucose levels are not controlled adequately while on study
  • Let us assume again for this example that , if glucose levels are not adequately controlled, they can be injected with insulin as a rescue medication
  • For analysis purposes, we want to identify the time from treatment start to first administration of this rescue medication after study treatment start
  • There will be subjects who never need rescue medication, and for these subjects we want to indicate that the rescue medication was not needed until study treatment end date
  • We want to differentiate the subjects who needed the rescue medication and who did not
  • We do that in a variable called CNSR (Censor)
  • For the subjects who needed rescue medication, we will populate as 0 and for the ones who did not, we populate it as 1
VARIABLE_NAMEVARIABLE_LABELDERIVATION
STARTDT Time-to-Event Origin Date for Subject Set to TRTSDT
PARAM Parameter Create a parameter named 'Time to first Rescure Medication' for each subject all safety subjects present in ADSL.
See AVAL for derivation logic.
PARAMCD Parameter Code Set to 'T2RESMED when PARAM="Time to first Rescue Medication"
ADT Analysis Date For PARAM="Time to first Rescue Medication"
     A. For subjects who took atleast dose of Insulin after treatment start:
     Get earliest CMSTDTC (after converting to numeric format) for each subject where CMDECOD="Insulin".
     B. For subjects who did not take insulin after treatment start
     Populate with TRTEDT.
CNSR Censor For PARAM="Time to first Rescue Medication"
     A. For subjects who took atleast dose of Insulin after treatment start:
     Set to 0
     B. For subjects who did not take insulin after treatment start
     Set to 1
AVAL Analysis Value Set to ADT-STARTDT+1.
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