Prepare datasets for AE specific analysis
Usage
prepare_ae_specific(
meta,
population,
observation,
parameter,
components = c("soc", "par"),
reference_group = NULL
)
Arguments
- meta
A metadata object created by metalite.
- population
A character value of population term name. The term name is used as key to link information.
- observation
A character value of observation term name. The term name is used as key to link information.
- parameter
A character value of parameter term name. The term name is used as key to link information.
- components
A character vector of components name.
- reference_group
An integer to indicate reference group. Default is 2 if there are 2 groups, otherwise, the default is 1.
Examples
meta <- meta_ae_example()
str(prepare_ae_specific(meta, "apat", "wk12", "rel"))
#> List of 15
#> $ meta :List of 7
#> ..$ data_population :'data.frame': 254 obs. of 49 variables:
#> .. ..$ STUDYID : chr [1:254] "CDISCPILOT01" "CDISCPILOT01" "CDISCPILOT01" "CDISCPILOT01" ...
#> .. .. ..- attr(*, "label")= chr "Study Identifier"
#> .. ..$ USUBJID : chr [1:254] "01-701-1015" "01-701-1023" "01-701-1028" "01-701-1033" ...
#> .. .. ..- attr(*, "label")= chr "Unique Subject Identifier"
#> .. ..$ SUBJID : chr [1:254] "1015" "1023" "1028" "1033" ...
#> .. .. ..- attr(*, "label")= chr "Subject Identifier for the Study"
#> .. ..$ SITEID : chr [1:254] "701" "701" "701" "701" ...
#> .. .. ..- attr(*, "label")= chr "Study Site Identifier"
#> .. ..$ SITEGR1 : chr [1:254] "701" "701" "701" "701" ...
#> .. .. ..- attr(*, "label")= chr "Pooled Site Group 1"
#> .. ..$ ARM : chr [1:254] "Placebo" "Placebo" "Xanomeline High Dose" "Xanomeline Low Dose" ...
#> .. .. ..- attr(*, "label")= chr "Description of Planned Arm"
#> .. ..$ TRT01P : chr [1:254] "Placebo" "Placebo" "Xanomeline High Dose" "Xanomeline Low Dose" ...
#> .. .. ..- attr(*, "label")= chr "Planned Treatment for Period 01"
#> .. ..$ TRT01PN : num [1:254] 0 0 81 54 81 0 54 54 54 0 ...
#> .. .. ..- attr(*, "label")= chr "Planned Treatment for Period 01 (N)"
#> .. ..$ TRT01A : chr [1:254] "Placebo" "Placebo" "Xanomeline High Dose" "Xanomeline Low Dose" ...
#> .. .. ..- attr(*, "label")= chr "Actual Treatment for Period 01"
#> .. ..$ TRT01AN : num [1:254] 0 0 81 54 81 0 54 54 54 0 ...
#> .. .. ..- attr(*, "label")= chr "Actual Treatment for Period 01 (N)"
#> .. ..$ TRTSDT : Date[1:254], format: "2014-01-02" "2012-08-05" ...
#> .. ..$ TRTEDT : Date[1:254], format: "2014-07-02" "2012-09-01" ...
#> .. ..$ TRTDUR : num [1:254] 182 28 180 14 183 26 190 10 55 182 ...
#> .. .. ..- attr(*, "label")= chr "Duration of Treatment (days)"
#> .. ..$ AVGDD : num [1:254] 0 0 77.7 54 76.9 0 54 54 54 0 ...
#> .. .. ..- attr(*, "label")= chr "Avg Daily Dose (as planned)"
#> .. ..$ CUMDOSE : num [1:254] 0 0 13986 756 14067 ...
#> .. .. ..- attr(*, "label")= chr "Cumulative Dose (as planned)"
#> .. ..$ AGE : num [1:254] 63 64 71 74 77 85 68 81 84 52 ...
#> .. .. ..- attr(*, "label")= chr "Age"
#> .. ..$ AGEGR1 : chr [1:254] "<65" "<65" "65-80" "65-80" ...
#> .. .. ..- attr(*, "label")= chr "Pooled Age Group 1"
#> .. ..$ AGEGR1N : num [1:254] 1 1 2 2 2 3 2 3 3 1 ...
#> .. .. ..- attr(*, "label")= chr "Pooled Age Group 1 (N)"
#> .. ..$ AGEU : chr [1:254] "YEARS" "YEARS" "YEARS" "YEARS" ...
#> .. .. ..- attr(*, "label")= chr "Age Units"
#> .. ..$ RACE : chr [1:254] "WHITE" "WHITE" "WHITE" "WHITE" ...
#> .. ..$ RACEN : num [1:254] 1 1 1 1 1 1 1 1 1 1 ...
#> .. .. ..- attr(*, "label")= chr "Race (N)"
#> .. ..$ SEX : chr [1:254] "F" "M" "M" "M" ...
#> .. .. ..- attr(*, "label")= chr "Sex"
#> .. ..$ ETHNIC : chr [1:254] "HISPANIC OR LATINO" "HISPANIC OR LATINO" "NOT HISPANIC OR LATINO" "NOT HISPANIC OR LATINO" ...
#> .. .. ..- attr(*, "label")= chr "Ethnicity"
#> .. ..$ SAFFL : chr [1:254] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Safety Population Flag"
#> .. ..$ ITTFL : chr [1:254] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Intent-To-Treat Population Flag"
#> .. ..$ EFFFL : chr [1:254] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Efficacy Population Flag"
#> .. ..$ COMP8FL : chr [1:254] "Y" "N" "Y" "N" ...
#> .. .. ..- attr(*, "label")= chr "Completers of Week 8 Population Flag"
#> .. ..$ COMP16FL: chr [1:254] "Y" "N" "Y" "N" ...
#> .. .. ..- attr(*, "label")= chr "Completers of Week 16 Population Flag"
#> .. ..$ COMP24FL: chr [1:254] "Y" "N" "Y" "N" ...
#> .. .. ..- attr(*, "label")= chr "Completers of Week 24 Population Flag"
#> .. ..$ DISCONFL: chr [1:254] "" "Y" "" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Did the Subject Discontinue the Study?"
#> .. ..$ DSRAEFL : chr [1:254] "" "Y" "" "" ...
#> .. .. ..- attr(*, "label")= chr "Discontinued due to AE?"
#> .. ..$ DTHFL : chr [1:254] "" "" "" "" ...
#> .. .. ..- attr(*, "label")= chr "Subject Died?"
#> .. ..$ BMIBL : num [1:254] 25.1 30.4 31.4 28.8 26.1 30.4 27.3 23.9 23.9 21.9 ...
#> .. .. ..- attr(*, "label")= chr "Baseline BMI (kg/m^2)"
#> .. ..$ BMIBLGR1: chr [1:254] "25-<30" ">=30" ">=30" "25-<30" ...
#> .. .. ..- attr(*, "label")= chr "Pooled Baseline BMI Group 1"
#> .. ..$ HEIGHTBL: num [1:254] 147 163 178 175 155 ...
#> .. .. ..- attr(*, "label")= chr "Baseline Height (cm)"
#> .. ..$ WEIGHTBL: num [1:254] 54.4 80.3 99.3 88.5 62.6 67.1 78 59.9 78.9 71.2 ...
#> .. .. ..- attr(*, "label")= chr "Baseline Weight (kg)"
#> .. ..$ EDUCLVL : num [1:254] 16 14 16 12 9 8 18 22 12 14 ...
#> .. .. ..- attr(*, "label")= chr "Years of Education"
#> .. ..$ DISONSDT: Date[1:254], format: "2010-04-30" "2006-03-11" ...
#> .. ..$ DURDIS : num [1:254] 43.9 76.4 42.8 55.3 32.9 ...
#> .. .. ..- attr(*, "label")= chr "Duration of Disease (Months)"
#> .. ..$ DURDSGR1: chr [1:254] ">=12" ">=12" ">=12" ">=12" ...
#> .. .. ..- attr(*, "label")= chr "Pooled Disease Duration Group 1"
#> .. ..$ VISIT1DT: Date[1:254], format: "2013-12-26" "2012-07-22" ...
#> .. ..$ RFSTDTC : chr [1:254] "2014-01-02" "2012-08-05" "2013-07-19" "2014-03-18" ...
#> .. .. ..- attr(*, "label")= chr "Subject Reference Start Date/Time"
#> .. ..$ RFENDTC : chr [1:254] "2014-07-02" "2012-09-02" "2014-01-14" "2014-04-14" ...
#> .. .. ..- attr(*, "label")= chr "Subject Reference End Date/Time"
#> .. ..$ VISNUMEN: num [1:254] 12 5 12 5 12 6 12 4 8 12 ...
#> .. .. ..- attr(*, "label")= chr "End of Trt Visit (Vis 12 or Early Term.)"
#> .. ..$ RFENDT : Date[1:254], format: "2014-07-02" "2012-09-02" ...
#> .. ..$ DCDECOD : chr [1:254] "COMPLETED" "ADVERSE EVENT" "COMPLETED" "STUDY TERMINATED BY SPONSOR" ...
#> .. .. ..- attr(*, "label")= chr "Standardized Disposition Term"
#> .. ..$ DCREASCD: chr [1:254] "Completed" "Adverse Event" "Completed" "Sponsor Decision" ...
#> .. .. ..- attr(*, "label")= chr "Reason for Discontinuation"
#> .. ..$ MMSETOT : num [1:254] 23 23 23 23 21 23 10 23 20 20 ...
#> .. .. ..- attr(*, "label")= chr "MMSE Total"
#> .. ..$ TRTA : Factor w/ 3 levels "Placebo","Low Dose",..: 1 1 3 2 3 1 2 2 2 1 ...
#> .. ..- attr(*, "data_name")= chr "adsl"
#> ..$ data_observation:'data.frame': 1191 obs. of 60 variables:
#> .. ..$ STUDYID : chr [1:1191] "CDISCPILOT01" "CDISCPILOT01" "CDISCPILOT01" "CDISCPILOT01" ...
#> .. .. ..- attr(*, "label")= chr "Study Identifier"
#> .. ..$ SITEID : chr [1:1191] "701" "701" "701" "701" ...
#> .. .. ..- attr(*, "label")= chr "Study Site Identifier"
#> .. ..$ USUBJID : chr [1:1191] "01-701-1015" "01-701-1015" "01-701-1015" "01-701-1023" ...
#> .. .. ..- attr(*, "label")= chr "Unique Subject Identifier"
#> .. ..$ TRTA : Factor w/ 3 levels "Placebo","Low Dose",..: 1 1 1 1 1 1 1 3 3 3 ...
#> .. ..$ TRTAN : num [1:1191] 0 0 0 0 0 0 0 81 81 81 ...
#> .. .. ..- attr(*, "label")= chr "Actual Treatment (N)"
#> .. ..$ AGE : num [1:1191] 63 63 63 64 64 64 64 71 71 77 ...
#> .. .. ..- attr(*, "label")= chr "Age"
#> .. ..$ AGEGR1 : chr [1:1191] "<65" "<65" "<65" "<65" ...
#> .. .. ..- attr(*, "label")= chr "Pooled Age Group 1"
#> .. ..$ AGEGR1N : num [1:1191] 1 1 1 1 1 1 1 2 2 2 ...
#> .. .. ..- attr(*, "label")= chr "Pooled Age Group 1 (N)"
#> .. ..$ RACE : chr [1:1191] "WHITE" "WHITE" "WHITE" "WHITE" ...
#> .. ..$ RACEN : num [1:1191] 1 1 1 1 1 1 1 1 1 1 ...
#> .. .. ..- attr(*, "label")= chr "Race (N)"
#> .. ..$ SEX : chr [1:1191] "F" "F" "F" "M" ...
#> .. .. ..- attr(*, "label")= chr "Sex"
#> .. ..$ SAFFL : chr [1:1191] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Safety Population Flag"
#> .. ..$ TRTSDT : Date[1:1191], format: "2014-01-02" "2014-01-02" ...
#> .. ..$ TRTEDT : Date[1:1191], format: "2014-07-02" "2014-07-02" ...
#> .. ..$ ASTDT : Date[1:1191], format: "2014-01-03" "2014-01-03" ...
#> .. ..$ ASTDTF : chr [1:1191] "" "" "" "" ...
#> .. .. ..- attr(*, "label")= chr "Analysis Start Date Imputation Flag"
#> .. ..$ ASTDY : num [1:1191] 2 2 8 3 3 22 3 3 21 58 ...
#> .. .. ..- attr(*, "label")= chr "Analysis Start Relative Day"
#> .. ..$ AENDT : Date[1:1191], format: NA NA ...
#> .. ..$ AENDY : num [1:1191] NA NA 10 26 NA NA 26 NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "Analysis End Relative Day"
#> .. ..$ ADURN : num [1:1191] NA NA 3 24 NA NA 24 NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "AE Duration (N)"
#> .. ..$ ADURU : chr [1:1191] "" "" "DAY" "DAY" ...
#> .. .. ..- attr(*, "label")= chr "AE Duration Units"
#> .. ..$ AETERM : chr [1:1191] "APPLICATION SITE ERYTHEMA" "APPLICATION SITE PRURITUS" "DIARRHOEA" "ERYTHEMA" ...
#> .. .. ..- attr(*, "label")= chr "Reported Term for the Adverse Event"
#> .. ..$ AELLT : chr [1:1191] "APPLICATION SITE REDNESS" "APPLICATION SITE ITCHING" "DIARRHEA" "ERYTHEMA" ...
#> .. .. ..- attr(*, "label")= chr "Lowest Level Term"
#> .. ..$ AELLTCD : num [1:1191] NA NA NA NA NA NA NA NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "Lowest Level Term Code"
#> .. ..$ AEDECOD : chr [1:1191] "APPLICATION SITE ERYTHEMA" "APPLICATION SITE PRURITUS" "DIARRHOEA" "ERYTHEMA" ...
#> .. .. ..- attr(*, "label")= chr "Adverse Event"
#> .. ..$ AEPTCD : num [1:1191] NA NA NA NA NA NA NA NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "Preferred Term Code"
#> .. ..$ AEHLT : chr [1:1191] "HLT_0617" "HLT_0317" "HLT_0148" "HLT_0284" ...
#> .. .. ..- attr(*, "label")= chr "High Level Term"
#> .. ..$ AEHLTCD : num [1:1191] NA NA NA NA NA NA NA NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "High Level Term Code"
#> .. ..$ AEHLGT : chr [1:1191] "HLGT_0152" "HLGT_0338" "HLGT_0588" "HLGT_0192" ...
#> .. .. ..- attr(*, "label")= chr "High Level Group Term"
#> .. ..$ AEHLGTCD : num [1:1191] NA NA NA NA NA NA NA NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "High Level Group Term Code"
#> .. ..$ AEBODSYS : chr [1:1191] "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" "GASTROINTESTINAL DISORDERS" "SKIN AND SUBCUTANEOUS TISSUE DISORDERS" ...
#> .. .. ..- attr(*, "label")= chr "Body System or Organ Class"
#> .. ..$ AESOC : chr [1:1191] "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" "GASTROINTESTINAL DISORDERS" "SKIN AND SUBCUTANEOUS TISSUE DISORDERS" ...
#> .. .. ..- attr(*, "label")= chr "Primary System Organ Class"
#> .. ..$ AESOCCD : num [1:1191] NA NA NA NA NA NA NA NA NA NA ...
#> .. .. ..- attr(*, "label")= chr "Primary System Organ Class Code"
#> .. ..$ AESEV : chr [1:1191] "MILD" "MILD" "MILD" "MILD" ...
#> .. .. ..- attr(*, "label")= chr "Intensity"
#> .. ..$ AESER : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Serious"
#> .. ..$ AESCAN : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Involves Cancer"
#> .. ..$ AESCONG : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Congenital Anomaly or Birth Defect"
#> .. ..$ AESDISAB : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Persist or Signif Disability/Incapacity"
#> .. ..$ AESDTH : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Results in Death"
#> .. ..$ AESHOSP : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Requires or Prolongs Hospitalization"
#> .. ..$ AESLIFE : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Is Life Threatening"
#> .. ..$ AESOD : chr [1:1191] "N" "N" "N" "N" ...
#> .. .. ..- attr(*, "label")= chr "Occurred with Overdose"
#> .. ..$ AEREL : chr [1:1191] "PROBABLE" "PROBABLE" "REMOTE" "POSSIBLE" ...
#> .. .. ..- attr(*, "label")= chr "Causality"
#> .. ..$ AEACN : chr [1:1191] "DOSE NOT CHANGED" "DOSE NOT CHANGED" "DOSE NOT CHANGED" "DOSE NOT CHANGED" ...
#> .. .. ..- attr(*, "label")= chr "Action Taken with Study Treatment"
#> .. ..$ AEOUT : chr [1:1191] "NOT RECOVERED/NOT RESOLVED" "NOT RECOVERED/NOT RESOLVED" "RECOVERED/RESOLVED" "NOT RECOVERED/NOT RESOLVED" ...
#> .. .. ..- attr(*, "label")= chr "Outcome of Adverse Event"
#> .. ..$ AESEQ : num [1:1191] 1 2 3 1 2 3 4 1 2 1 ...
#> .. .. ..- attr(*, "label")= chr "Sequence Number"
#> .. ..$ TRTEMFL : chr [1:1191] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "Treatment Emergent Analysis Flag"
#> .. ..$ AOCCFL : chr [1:1191] "Y" "" "" "Y" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence of Any AE Flag"
#> .. ..$ AOCCSFL : chr [1:1191] "Y" "" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence of SOC Flag"
#> .. ..$ AOCCPFL : chr [1:1191] "Y" "Y" "Y" "Y" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence of Preferred Term Flag"
#> .. ..$ AOCC02FL : chr [1:1191] "" "" "" "" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence 02 Flag for Serious"
#> .. ..$ AOCC03FL : chr [1:1191] "" "" "" "" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence 03 Flag for Serious SOC"
#> .. ..$ AOCC04FL : chr [1:1191] "" "" "" "" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence 04 Flag for Serious PT"
#> .. ..$ CQ01NAM : chr [1:1191] "DERMATOLOGIC EVENTS" "DERMATOLOGIC EVENTS" "" "DERMATOLOGIC EVENTS" ...
#> .. .. ..- attr(*, "label")= chr "Customized Query 01 Name"
#> .. ..$ AOCC01FL : chr [1:1191] "Y" "" "" "Y" ...
#> .. .. ..- attr(*, "label")= chr "1st Occurrence 01 Flag for CQ01"
#> .. ..$ related : chr [1:1191] "Probable" "Probable" "Remote" "Possible" ...
#> .. .. ..- attr(*, "label")= chr "Related"
#> .. ..$ outcome : chr [1:1191] "Resolved" "Resolved" "Resolved" "Resolved" ...
#> .. .. ..- attr(*, "label")= chr "Outcome"
#> .. ..$ action_taken: chr [1:1191] "None" "None" "None" "None" ...
#> .. .. ..- attr(*, "label")= chr "Action Taken"
#> .. ..$ duration : chr [1:1191] "Continuing" "Continuing" "3 Day" "24 Day" ...
#> .. .. ..- attr(*, "label")= chr "Duration"
#> .. ..$ subline : chr [1:1191] "Subject ID = 01-701-1015, Gender = F, Race = WHITE, AGE = 63 Years, TRT = Placebo" "Subject ID = 01-701-1015, Gender = F, Race = WHITE, AGE = 63 Years, TRT = Placebo" "Subject ID = 01-701-1015, Gender = F, Race = WHITE, AGE = 63 Years, TRT = Placebo" "Subject ID = 01-701-1023, Gender = M, Race = WHITE, AGE = 64 Years, TRT = Placebo" ...
#> .. ..- attr(*, "data_name")= chr "adae"
#> ..$ plan :Classes ‘meta_plan’ and 'data.frame': 18 obs. of 5 variables:
#> .. ..$ mock : num [1:18] 1 1 2 2 2 2 2 2 2 2 ...
#> .. ..$ analysis : chr [1:18] "ae_summary" "ae_summary" "ae_specific" "ae_specific" ...
#> .. ..$ population : chr [1:18] "apat" "apat" "apat" "apat" ...
#> .. ..$ observation: chr [1:18] "wk12" "wk24" "wk12" "wk24" ...
#> .. ..$ parameter : chr [1:18] "any;rel;ser" "any;rel;ser" "any" "any" ...
#> .. ..- attr(*, "out.attrs")=List of 2
#> .. .. ..$ dim : Named int [1:5] 1 1 1 2 1
#> .. .. .. ..- attr(*, "names")= chr [1:5] "mock" "analysis" "population" "observation" ...
#> .. .. ..$ dimnames:List of 5
#> .. .. .. ..$ mock : chr "mock=1"
#> .. .. .. ..$ analysis : chr "analysis=ae_summary"
#> .. .. .. ..$ population : chr "population=apat"
#> .. .. .. ..$ observation: chr [1:2] "observation=wk12" "observation=wk24"
#> .. .. .. ..$ parameter : chr "parameter=any;rel;ser"
#> ..$ observation :List of 2
#> .. ..$ wk12:List of 6
#> .. .. ..$ name : chr "wk12"
#> .. .. ..$ id : chr "USUBJID"
#> .. .. ..$ group : chr "TRTA"
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: language SAFFL == "Y"
#> .. .. ..$ label : chr "Weeks 0 to 12"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ wk24:List of 6
#> .. .. ..$ name : chr "wk24"
#> .. .. ..$ id : chr "USUBJID"
#> .. .. ..$ group : chr "TRTA"
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: language AOCC01FL == "Y"
#> .. .. ..$ label : chr "Weeks 0 to 24"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> ..$ population :List of 1
#> .. ..$ apat:List of 6
#> .. .. ..$ name : chr "apat"
#> .. .. ..$ id : chr "USUBJID"
#> .. .. ..$ group : chr "TRTA"
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: language SAFFL == "Y"
#> .. .. ..$ label : chr "All Participants as Treated"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> ..$ parameter :List of 4
#> .. ..$ rel :List of 12
#> .. .. ..$ name : chr "rel"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : chr "AEDECOD"
#> .. .. ..$ subset : language AEREL %in% c("POSSIBLE", "PROBABLE")
#> .. .. ..$ label : chr "drug-related adverse events"
#> .. .. ..$ soc : chr "AEBODSYS"
#> .. .. ..$ seq : num 200
#> .. .. ..$ term1 : chr "Drug-Related"
#> .. .. ..$ term2 : chr ""
#> .. .. ..$ summ_row : chr "with drug-related{^a} adverse events"
#> .. .. ..$ summ_foot: chr "{^a}Determined by the investigator to be related to the drug."
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ aeosi:List of 9
#> .. .. ..$ name : chr "aeosi"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : chr "AEDECOD"
#> .. .. ..$ subset: language AEOSI == "Y"
#> .. .. ..$ label : chr "adverse events of special interest"
#> .. .. ..$ soc : chr "AEBODSYS"
#> .. .. ..$ term1 : chr ""
#> .. .. ..$ term2 : chr "of special interest"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ any :List of 11
#> .. .. ..$ name : chr "any"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : chr "AEDECOD"
#> .. .. ..$ subset : NULL
#> .. .. ..$ label : chr "any adverse events"
#> .. .. ..$ soc : chr "AEBODSYS"
#> .. .. ..$ seq : num 100
#> .. .. ..$ term1 : chr ""
#> .. .. ..$ term2 : chr ""
#> .. .. ..$ summ_row: chr "with one or more adverse events"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ ser :List of 11
#> .. .. ..$ name : chr "ser"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : chr "AEDECOD"
#> .. .. ..$ subset : language AESER == "Y"
#> .. .. ..$ label : chr "serious adverse events"
#> .. .. ..$ soc : chr "AEBODSYS"
#> .. .. ..$ seq : num 401
#> .. .. ..$ term1 : chr "Serious"
#> .. .. ..$ term2 : chr ""
#> .. .. ..$ summ_row: chr "with serious adverse events"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> ..$ analysis :List of 4
#> .. ..$ ae_summary :List of 7
#> .. .. ..$ name : chr "ae_summary"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: NULL
#> .. .. ..$ label : chr "Table: adverse event summary"
#> .. .. ..$ title : chr "Summary of Adverse Events"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ ae_listing :List of 11
#> .. .. ..$ name : chr "ae_listing"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : NULL
#> .. .. ..$ subset : NULL
#> .. .. ..$ label : chr "Listing: adverse event"
#> .. .. ..$ var_name : chr [1:9] "USUBJID" "ASTDY" "AEDECOD" "duration" ...
#> .. .. ..$ subline_by: NULL
#> .. .. ..$ group_by : chr [1:2] "USUBJID" "ASTDY"
#> .. .. ..$ page_by : chr [1:2] "TRTA" "subline"
#> .. .. ..$ title : chr "Listing of Participants With {term1} Adverse Events {term2}"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ ae_exp_adj :List of 7
#> .. .. ..$ name : chr "ae_exp_adj"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: NULL
#> .. .. ..$ label : chr "Exposure Adjusted Incident Rate"
#> .. .. ..$ title : chr "Exposure-Adjusted Adverse Event Summary"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> .. ..$ ae_specific:List of 7
#> .. .. ..$ name : chr "ae_specific"
#> .. .. ..$ id : NULL
#> .. .. ..$ group : NULL
#> .. .. ..$ var : NULL
#> .. .. ..$ subset: NULL
#> .. .. ..$ label : chr "Table: specific adverse event"
#> .. .. ..$ title : chr "Participants With {term1} Adverse Events {term2}"
#> .. .. ..- attr(*, "class")= chr "adam_mapping"
#> ..- attr(*, "class")= chr "meta_adam"
#> $ population : chr "apat"
#> $ observation : chr "wk12"
#> $ parameter : chr "rel"
#> $ n :'data.frame': 138 obs. of 4 variables:
#> ..$ n_1: int [1:138] 86 44 42 NA 6 1 0 1 1 1 ...
#> ..$ n_2: int [1:138] 84 73 11 NA 7 0 1 0 0 0 ...
#> ..$ n_3: int [1:138] 84 70 14 NA 4 2 0 0 0 0 ...
#> ..$ n_4: int [1:138] 254 187 67 NA 17 3 1 1 1 1 ...
#> $ order : num [1:138] 1 100 200 900 1000 ...
#> $ group : chr [1:4] "Placebo" "Low Dose" "High Dose" "Total"
#> $ reference_group: num 1
#> $ prop :'data.frame': 138 obs. of 4 variables:
#> ..$ prop_1: num [1:138] NA 51.16 48.84 NA 6.98 ...
#> ..$ prop_2: num [1:138] NA 86.9 13.1 NA 8.33 ...
#> ..$ prop_3: num [1:138] NA 83.33 16.67 NA 4.76 ...
#> ..$ prop_4: num [1:138] NA 73.62 26.38 NA 6.69 ...
#> $ diff :'data.frame': 138 obs. of 2 variables:
#> ..$ diff_2: num [1:138] NA 35.74 -35.74 NA 1.36 ...
#> ..$ diff_3: num [1:138] NA 32.17 -32.17 NA -2.21 ...
#> $ n_pop :'data.frame': 1 obs. of 4 variables:
#> ..$ n_1: int 86
#> ..$ n_2: int 84
#> ..$ n_3: int 84
#> ..$ n_4: int 254
#> $ name : chr [1:138] "Participants in population" "with one or more drug-related adverse events" "with no drug-related adverse events" "" ...
#> $ soc_name : chr [1:138] NA NA NA NA ...
#> $ components : chr [1:2] "soc" "par"
#> $ prepare_call : language prepare_ae_specific(meta = meta, population = "apat", observation = "wk12", parameter = "rel")
#> - attr(*, "class")= chr "outdata"
# Allow to extract each components
prepare_ae_specific(meta, "apat", "wk12", "rel", components = NULL)$data
#> NULL
prepare_ae_specific(meta, "apat", "wk12", "rel", components = "soc")$data
#> NULL
prepare_ae_specific(meta, "apat", "wk12", "rel", components = "par")$data
#> NULL