Skip to contents

Pre-Defined Response Event Objects

Source: R/response_sources.R
event_objects.Rd

These pre-defined event() and event_joined() objects can be used as input to admiral::derive_extreme_event().

Usage

rsp_y

no_data_n

cb_y

bor_cr

bor_pr

bor_sd

bor_non_crpd

bor_pd

bor_ne

no_data_missing

crsp_y_cr

crsp_y_pr

cbor_cr

cbor_pr

Details

To see the definition of the various objects simply print the object in the R console, e.g. bor_sd. For details of how to use these objects please refer to admiral::derive_extreme_event().

It is assumed that dataset_name = "ovr" refers to the dataset of the only overall response assessments at each visit which should be considered for the parameter derivations. For example the dataset should include only post-baseline assessments up to first PD and before start of anti-cancer therapy.

See also

admiral::derive_extreme_event(), admiral::event(), admiral::event_joined()

Examples

# This shows the definition of all pre-defined `event` objects that ship
# with {admiralonco}
exports <- sort(getNamespaceExports("admiralonco"))
for (obj_name in exports) {
  obj <- getExportedValue("admiralonco", obj_name)
  if (inherits(obj, "event_def")) {
    cat("\n", obj_name, ":\n", sep = "")
    print(obj, indent = 2)
  }
}
#> 
#> bor_cr:
#>   <event> object
#>   description: "Define complete response (CR) for best overall response (BOR)"
#>   dataset_name: "ovr"
#>   condition: AVALC == "CR"
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "CR"
#>   keep_source_vars: NULL
#> 
#> bor_ne:
#>   <event> object
#>   description: "Define not evaluable (NE) for best overall response (BOR) as CR, PR, SD, NON-CR/NON-PD, or NE (should be specified after bor_sd and bor_non_crpd)"
#>   dataset_name: "ovr"
#>   condition: AVALC %in% c("CR", "PR", "SD", "NON-CR/NON-PD", "NE")
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "NE"
#>   keep_source_vars: NULL
#> 
#> bor_non_crpd:
#>   <event> object
#>   description: "Define NON-CR/NON-PD for best overall response (BOR) as NON-CR/NON-PD occuring at least 42 days after randomization"
#>   dataset_name: "ovr"
#>   condition: AVALC == "NON-CR/NON-PD" & ADT >= RANDDT + 42
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "NON-CR/NON-PD"
#>   keep_source_vars: NULL
#> 
#> bor_pd:
#>   <event> object
#>   description: "Define progressive disease (PD) for best overall response (BOR)"
#>   dataset_name: "ovr"
#>   condition: AVALC == "PD"
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "PD"
#>   keep_source_vars: NULL
#> 
#> bor_pr:
#>   <event> object
#>   description: "Define partial response (PR) for best overall response (BOR)"
#>   dataset_name: "ovr"
#>   condition: AVALC == "PR"
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "PR"
#>   keep_source_vars: NULL
#> 
#> bor_sd:
#>   <event> object
#>   description: "Define stable disease (SD) for best overall respone (BOR) as CR, PR, or SD occurring at least 42 days after randomization"
#>   dataset_name: "ovr"
#>   condition: AVALC %in% c("CR", "PR", "SD") & ADT >= RANDDT + 42
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "SD"
#>   keep_source_vars: NULL
#> 
#> cb_y:
#>   <event> object
#>   description: "Define CR, PR, SD, or NON-CR/NON-PD occuring at least 42 days after randomization as clinical benefit"
#>   dataset_name: "ovr"
#>   condition: AVALC %in% c("CR", "PR", "SD", "NON-CR/NON-PD") & ADT >= RANDDT + 
#>     42
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "Y"
#>   keep_source_vars: NULL
#> 
#> cbor_cr:
#>   <event_joined> object
#>   description: "Define complete response (CR) for confirmed best overall response (CBOR) as CR followed by CR at least 28 days later and at most one NE in between"
#>   dataset_name: "ovr"
#>   condition: AVALC == "CR" & all(AVALC.join %in% c("CR", "NE")) & count_vals(var = AVALC.join, 
#>     val = "NE") <= 1
#>   order: NULL
#>   join_vars:
#>     AVALC
#>     ADT
#>   join_type: "after"
#>   first_cond_lower: NULL
#>   first_cond_upper: AVALC.join == "CR" & ADT.join >= ADT + 28
#>   set_values_to:
#>     AVALC: "CR"
#>   keep_source_vars: NULL
#> 
#> cbor_pr:
#>   <event_joined> object
#>   description: "Define partial response (PR) for confirmed best overall response (CBOR) as PR followed by CR or PR at least 28 days later, at most one NE in between, and no PR after CR"
#>   dataset_name: "ovr"
#>   condition: AVALC == "PR" & all(AVALC.join %in% c("CR", "PR", "NE")) & count_vals(var = AVALC.join, 
#>     val = "NE") <= 1 & (min_cond(var = ADT.join, cond = AVALC.join == 
#>     "CR") > max_cond(var = ADT.join, cond = AVALC.join == "PR") | 
#>     count_vals(var = AVALC.join, val = "CR") == 0 | count_vals(var = AVALC.join, 
#>     val = "PR") == 0)
#>   order: NULL
#>   join_vars:
#>     AVALC
#>     ADT
#>   join_type: "after"
#>   first_cond_lower: NULL
#>   first_cond_upper: AVALC.join %in% c("CR", "PR") & ADT.join >= ADT + 28
#>   set_values_to:
#>     AVALC: "PR"
#>   keep_source_vars: NULL
#> 
#> crsp_y_cr:
#>   <event_joined> object
#>   description: "Define confirmed response as CR followed by CR at least 28 days later and at most one NE in between"
#>   dataset_name: "ovr"
#>   condition: AVALC == "CR" & all(AVALC.join %in% c("CR", "NE")) & count_vals(var = AVALC.join, 
#>     val = "NE") <= 1
#>   order:
#>     ADT
#>   join_vars:
#>     AVALC
#>     ADT
#>   join_type: "after"
#>   first_cond_lower: NULL
#>   first_cond_upper: AVALC.join == "CR" & ADT.join >= ADT + days(28)
#>   set_values_to:
#>     AVALC: "Y"
#>   keep_source_vars: NULL
#> 
#> crsp_y_pr:
#>   <event_joined> object
#>   description: "Define confirmed response as PR followed by CR or PR at least 28 days later, at most one NE in between, and no PR after CR"
#>   dataset_name: "ovr"
#>   condition: AVALC == "PR" & all(AVALC.join %in% c("CR", "PR", "NE")) & count_vals(var = AVALC.join, 
#>     val = "NE") <= 1 & (min_cond(var = ADT.join, cond = AVALC.join == 
#>     "CR") > max_cond(var = ADT.join, cond = AVALC.join == "PR") | 
#>     count_vals(var = AVALC.join, val = "CR") == 0 | count_vals(var = AVALC.join, 
#>     val = "PR") == 0)
#>   order:
#>     ADT
#>   join_vars:
#>     AVALC
#>     ADT
#>   join_type: "after"
#>   first_cond_lower: NULL
#>   first_cond_upper: AVALC.join %in% c("CR", "PR") & ADT.join >= ADT + days(28)
#>   set_values_to:
#>     AVALC: "Y"
#>   keep_source_vars: NULL
#> 
#> no_data_missing:
#>   <event> object
#>   description: "Define missing response (MISSING) for all subjects in adsl in your population who has no post baseline response (should be used as last event)"
#>   dataset_name: "adsl"
#>   condition: TRUE
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "MISSING"
#>   keep_source_vars:
#>     RANDDT
#> 
#> no_data_n:
#>   <event> object
#>   description: "Define no response for all patients in adsl (should be used as last event)"
#>   dataset_name: "adsl"
#>   condition: TRUE
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "N"
#>   keep_source_vars:
#>     RANDDT
#> 
#> rsp_y:
#>   <event> object
#>   description: "Define CR or PR as (unconfirmed) response"
#>   dataset_name: "ovr"
#>   condition: AVALC %in% c("CR", "PR")
#>   mode: NULL
#>   order: NULL
#>   set_values_to:
#>     AVALC: "Y"
#>   keep_source_vars: NULL