{ "cells": [ { "cell_type": "markdown", "metadata": { "id": "view-in-github", "colab_type": "text" }, "source": [ "\"Open" ] }, { "cell_type": "code", "execution_count": null, "id": "42bec6b2-e96a-4412-8c6c-045478bc8e2f", "metadata": { "id": "42bec6b2-e96a-4412-8c6c-045478bc8e2f" }, "outputs": [], "source": [ "library(glue)\n", "library(tidyverse)\n", "library(haven)\n", "library(assertthat)\n", "library(huxtable)\n", "library(data.table)\n", "library(lubridate)\n", "library(pharmaRTF)" ] }, { "cell_type": "code", "execution_count": null, "id": "e52840d8-7edf-4160-8e51-6ac128559425", "metadata": { "id": "e52840d8-7edf-4160-8e51-6ac128559425", "outputId": "cb8e95d3-32fb-47c4-cdb3-b79610fabebb" }, "outputs": [ { "data": { "text/html": [ "\n", "
  1. 'dm'
  2. 'ds'
  3. 'suppdm'
  4. 'vs'
\n" ], "text/latex": [ "\\begin{enumerate*}\n", "\\item 'dm'\n", "\\item 'ds'\n", "\\item 'suppdm'\n", "\\item 'vs'\n", "\\end{enumerate*}\n" ], "text/markdown": [ "1. 'dm'\n", "2. 'ds'\n", "3. 'suppdm'\n", "4. 'vs'\n", "\n", "\n" ], "text/plain": [ "[1] \"dm\" \"ds\" \"suppdm\" \"vs\" " ] }, "metadata": {}, "output_type": "display_data" } ], "source": [ "load(\"Data_Need_forADSL.RData\")\n", "ls()" ] }, { "cell_type": "markdown", "id": "20b970f1-2da2-4cfd-9ec8-d56e60e69800", "metadata": { "id": "20b970f1-2da2-4cfd-9ec8-d56e60e69800" }, "source": [ "**Merge DM and SUPPDM**" ] }, { "cell_type": "markdown", "id": "179db65b-1676-4343-a56c-d1176e58b25b", "metadata": { "id": "179db65b-1676-4343-a56c-d1176e58b25b" }, "source": [ "Transponse SUPPDM data such that each QNAM becomes a variable" ] }, { "cell_type": "code", "execution_count": null, "id": "ec81c37c-fb8c-487a-9bd8-ab893e046aaf", "metadata": { "id": "ec81c37c-fb8c-487a-9bd8-ab893e046aaf" }, "outputs": [], "source": [ "suppdm01 <- suppdm %>%\n", " mutate(qnam=str_to_lower(qnam)) %>%\n", " group_by(studyid, usubjid) %>%\n", " pivot_wider(id_cols=c(studyid,usubjid),names_from = qnam, values_from = qval)\n", "\n", "dm01 <- left_join(dm, suppdm01, by = c(\"studyid\", \"usubjid\"))" ] }, { "cell_type": "code", "execution_count": null, "id": "6a50d26f-5fae-41e2-9798-cc1564661e6f", "metadata": { "id": "6a50d26f-5fae-41e2-9798-cc1564661e6f" }, "outputs": [], "source": [ "dm01" ] }, { "cell_type": "markdown", "id": "f27bd7fd-c448-4ad3-8353-fb5cf30471f7", "metadata": { "id": "f27bd7fd-c448-4ad3-8353-fb5cf30471f7" }, "source": [ "**Create variables that are directly based on input variables**" ] }, { "cell_type": "code", "execution_count": null, "id": "96a0c3e9-9324-4200-9222-3ed032ebe04e", "metadata": { "id": "96a0c3e9-9324-4200-9222-3ed032ebe04e" }, "outputs": [], "source": [ "adsl01 <- dm01 %>%\n", "\n", " # Planned and actual treatment values;\n", "\n", "mutate(trt01p = if_else(armcd == \"PBO\", \"Placebo\", if_else(armcd == \"ACTIVE\", \"Active\", \"\")),\n", " trt01a = if_else(actarmcd == \"PBO\", \"Placebo\", if_else(actarmcd == \"ACTIVE\", \"Active\", \"\")),\n", " trt01pn = if_else(armcd == \"PBO\", 1, if_else(armcd == \"ACTIVE\", 2, NA)),\n", " trt01an = if_else(actarmcd == \"PBO\", 1, if_else(actarmcd == \"ACTIVE\", 2, NA))) %>%\n", "\n", " # Date conversions\n", "\n", "mutate(tr01sdt = as.Date(rfxstdtc),\n", "tr01edt = as.Date(rfxendtc),\n", "rficdt = as.Date(rficdtc),\n", "lstalvdt = as.Date(rfpendtc),\n", "dthdt = as.Date(dthdtc),\n", "trtsdt = tr01sdt,\n", "trtedt = tr01edt) %>%\n", "\n", " # Grouping variables\n", "mutate(agegr1 = if_else(!is.na(age) & age < 60, \"< 60 Years\",\n", "if_else(age >= 60, \">= 60 Years\", \"\")),\n", "agegr1n = if_else(!is.na(age) & age < 60, 1, if_else(age >= 60, 2,NA)))" ] }, { "cell_type": "code", "execution_count": null, "id": "641f2387-dbbd-465c-ba7a-9aa7195f51e4", "metadata": { "id": "641f2387-dbbd-465c-ba7a-9aa7195f51e4", "outputId": "b0e860ec-915c-47e5-eb8e-6efde632e385" }, "outputs": [ { "data": { "text/html": [ "\n", "\n", "\n", "\t\n", "\t\n", "\n", "\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\n", "
A tibble: 8 × 8
usubjidtrt01ptrt01atrt01pntrt01anagegr1agegr1nethnic
<chr><chr><chr><dbl><dbl><chr><dbl><chr>
CSG001-1001 NANA< 60 Years 1HISPANIC OR LATINO
CSG001-1002 NANA< 60 Years 1NOT HISPANIC OR LATINO
CSG001-1003Placebo 1NA< 60 Years 1HISPANIC OR LATINO
CSG001-1004Active Active 2 2< 60 Years 1HISPANIC OR LATINO
CSG001-1005Active Placebo 2 1>= 60 Years2NOT HISPANIC OR LATINO
CSG001-1006PlaceboPlacebo 1 1>= 60 Years2NOT HISPANIC OR LATINO
CSG001-1007PlaceboPlacebo 1 1< 60 Years 1NOT HISPANIC OR LATINO
CSG001-1008Active Active 2 2>= 60 Years2NOT HISPANIC OR LATINO
\n" ], "text/latex": [ "A tibble: 8 × 8\n", "\\begin{tabular}{llllllll}\n", " usubjid & trt01p & trt01a & trt01pn & trt01an & agegr1 & agegr1n & ethnic\\\\\n", " & & & & & & & \\\\\n", "\\hline\n", "\t CSG001-1001 & & & NA & NA & < 60 Years & 1 & HISPANIC OR LATINO \\\\\n", "\t CSG001-1002 & & & NA & NA & < 60 Years & 1 & NOT HISPANIC OR LATINO\\\\\n", "\t CSG001-1003 & Placebo & & 1 & NA & < 60 Years & 1 & HISPANIC OR LATINO \\\\\n", "\t CSG001-1004 & Active & Active & 2 & 2 & < 60 Years & 1 & HISPANIC OR LATINO \\\\\n", "\t CSG001-1005 & Active & Placebo & 2 & 1 & >= 60 Years & 2 & NOT HISPANIC OR LATINO\\\\\n", "\t CSG001-1006 & Placebo & Placebo & 1 & 1 & >= 60 Years & 2 & NOT HISPANIC OR LATINO\\\\\n", "\t CSG001-1007 & Placebo & Placebo & 1 & 1 & < 60 Years & 1 & NOT HISPANIC OR LATINO\\\\\n", "\t CSG001-1008 & Active & Active & 2 & 2 & >= 60 Years & 2 & NOT HISPANIC OR LATINO\\\\\n", "\\end{tabular}\n" ], "text/markdown": [ "\n", "A tibble: 8 × 8\n", "\n", "| usubjid <chr> | trt01p <chr> | trt01a <chr> | trt01pn <dbl> | trt01an <dbl> | agegr1 <chr> | agegr1n <dbl> | ethnic <chr> |\n", "|---|---|---|---|---|---|---|---|\n", "| CSG001-1001 | | | NA | NA | < 60 Years | 1 | HISPANIC OR LATINO |\n", "| CSG001-1002 | | | NA | NA | < 60 Years | 1 | NOT HISPANIC OR LATINO |\n", "| CSG001-1003 | Placebo | | 1 | NA | < 60 Years | 1 | HISPANIC OR LATINO |\n", "| CSG001-1004 | Active | Active | 2 | 2 | < 60 Years | 1 | HISPANIC OR LATINO |\n", "| CSG001-1005 | Active | Placebo | 2 | 1 | >= 60 Years | 2 | NOT HISPANIC OR LATINO |\n", "| CSG001-1006 | Placebo | Placebo | 1 | 1 | >= 60 Years | 2 | NOT HISPANIC OR LATINO |\n", "| CSG001-1007 | Placebo | Placebo | 1 | 1 | < 60 Years | 1 | NOT HISPANIC OR LATINO |\n", "| CSG001-1008 | Active | Active | 2 | 2 | >= 60 Years | 2 | NOT HISPANIC OR LATINO |\n", "\n" ], "text/plain": [ " usubjid trt01p trt01a trt01pn trt01an agegr1 agegr1n\n", "1 CSG001-1001 NA NA < 60 Years 1 \n", "2 CSG001-1002 NA NA < 60 Years 1 \n", "3 CSG001-1003 Placebo 1 NA < 60 Years 1 \n", "4 CSG001-1004 Active Active 2 2 < 60 Years 1 \n", "5 CSG001-1005 Active Placebo 2 1 >= 60 Years 2 \n", "6 CSG001-1006 Placebo Placebo 1 1 >= 60 Years 2 \n", "7 CSG001-1007 Placebo Placebo 1 1 < 60 Years 1 \n", "8 CSG001-1008 Active Active 2 2 >= 60 Years 2 \n", " ethnic \n", "1 HISPANIC OR LATINO \n", "2 NOT HISPANIC OR LATINO\n", "3 HISPANIC OR LATINO \n", "4 HISPANIC OR LATINO \n", "5 NOT HISPANIC OR LATINO\n", "6 NOT HISPANIC OR LATINO\n", "7 NOT HISPANIC OR LATINO\n", "8 NOT HISPANIC OR LATINO" ] }, "metadata": {}, "output_type": "display_data" } ], "source": [ " select(adsl01, c('usubjid', 'trt01p','trt01a','trt01pn', 'trt01an','agegr1','agegr1n', 'ethnic'))" ] }, { "cell_type": "markdown", "id": "2e96eea8-c316-4a60-8233-6e4da9e2c338", "metadata": { "id": "2e96eea8-c316-4a60-8233-6e4da9e2c338" }, "source": [ "**Process disposition data for treatment and study status** \n", " \n", "Enrollment" ] }, { "cell_type": "code", "execution_count": null, "id": "77d1ed95-3bbc-40e3-8710-03f382ab8b88", "metadata": { "id": "77d1ed95-3bbc-40e3-8710-03f382ab8b88" }, "outputs": [], "source": [ "enrl01 <- ds %>%\n", "filter(dsterm == \"ENROLLED\") %>%\n", "mutate(enrldt = as.Date(dsstdtc)) %>%\n", "select(studyid, usubjid, enrldt)" ] }, { "cell_type": "markdown", "id": "a71c2101-b71a-4a65-940b-5576b1df1016", "metadata": { "id": "a71c2101-b71a-4a65-940b-5576b1df1016" }, "source": [ "Randomization" ] }, { "cell_type": "code", "execution_count": null, "id": "d48626ca-f774-4e23-bb48-2b733d3405b0", "metadata": { "id": "d48626ca-f774-4e23-bb48-2b733d3405b0" }, "outputs": [], "source": [ "rand01 <- ds %>%\n", "filter(dsterm == \"RANDOMIZED\") %>%\n", "mutate(randdt = as.Date(dsstdtc)) %>%\n", "select(studyid, usubjid, randdt)" ] }, { "cell_type": "markdown", "id": "e2653a2f-1d0b-4013-b0fe-51e282d0a4f8", "metadata": { "id": "e2653a2f-1d0b-4013-b0fe-51e282d0a4f8" }, "source": [ "End of treatment" ] }, { "cell_type": "code", "execution_count": null, "id": "807bec6a-c087-495c-ae4e-dcac7c3b2004", "metadata": { "id": "807bec6a-c087-495c-ae4e-dcac7c3b2004" }, "outputs": [], "source": [ "eot01 <- ds %>%\n", " filter(dsscat == \"END OF TREATMENT\") %>%\n", " mutate(\n", " eotstt = case_when(\n", " dsdecod == \"COMPLETED\" ~ \"COMPLETED\",\n", " dsdecod != \"\" ~ \"DISCONTINUED\",\n", " TRUE ~ NA\n", " ),\n", " dctreas = if_else(dsdecod != \"COMPLETED\", dsdecod, NA),\n", " ineot = 1\n", " ) %>%\n", " select(studyid, usubjid, eotstt, dctreas, ineot)" ] }, { "cell_type": "markdown", "id": "5c1e78b2-3515-4ec2-8fa5-36bb86ad8c27", "metadata": { "id": "5c1e78b2-3515-4ec2-8fa5-36bb86ad8c27" }, "source": [ "\n", " \n", "End of study;" ] }, { "cell_type": "code", "execution_count": null, "id": "6ba40640-e39d-46a8-944a-a3a6b0b183b9", "metadata": { "id": "6ba40640-e39d-46a8-944a-a3a6b0b183b9" }, "outputs": [], "source": [ "eos01 <- ds %>%\n", " filter(dsscat == \"END OF STUDY\") %>%\n", " mutate(\n", " eosstt = case_when(\n", " dsdecod == \"COMPLETED\" ~ \"COMPLETED\",\n", " dsdecod != \"\" ~ \"DISCONTINUED\",\n", " TRUE ~ NA\n", " ),\n", " dcsreas = if_else(dsdecod != \"COMPLETED\", dsdecod, NA),\n", " eosdt = as.Date(dsstdtc),\n", " ineos = 1\n", " ) %>%\n", " select(studyid, usubjid, eosstt, dcsreas, eosdt, ineos)" ] }, { "cell_type": "markdown", "id": "0177671d-b0bc-4a47-b6d0-df116b70a45c", "metadata": { "id": "0177671d-b0bc-4a47-b6d0-df116b70a45c" }, "source": [ "Baseline variables from vital signs;" ] }, { "cell_type": "code", "execution_count": null, "id": "255179c5-e721-488b-a524-7b699f6a2c4a", "metadata": { "id": "255179c5-e721-488b-a524-7b699f6a2c4a" }, "outputs": [], "source": [ "heightbl <- vs %>%\n", " filter(vsblfl == \"Y\" & vstestcd == \"HEIGHT\") %>%\n", " select(studyid, usubjid, vsstresn) %>%\n", " rename(heightbl = vsstresn)\n", "\n", "weightbl <- vs %>%\n", " filter(vsblfl == \"Y\" & vstestcd == \"WEIGHT\") %>%\n", " select(studyid, usubjid, vsstresn) %>%\n", " rename(weightbl = vsstresn)\n", "\n" ] }, { "cell_type": "markdown", "id": "b7773791-11c1-432f-8739-c9ed8773230a", "metadata": { "id": "b7773791-11c1-432f-8739-c9ed8773230a" }, "source": [ "Bring disposition and vital signs related info into parent dataset;" ] }, { "cell_type": "code", "execution_count": null, "id": "15e8560f-20fd-41b8-83d3-eddd944368f7", "metadata": { "id": "15e8560f-20fd-41b8-83d3-eddd944368f7" }, "outputs": [], "source": [ "library(purrr)\n", "\n", "data_frames <- list(adsl01, eot01, eos01, enrl01, rand01, heightbl, weightbl)\n", "\n", "adsl02 <- reduce(data_frames, left_join, by = c(\"studyid\", \"usubjid\"))" ] }, { "cell_type": "markdown", "id": "5d1ce0f6-7ce7-4bf3-ad85-9b5d6104ae60", "metadata": { "id": "5d1ce0f6-7ce7-4bf3-ad85-9b5d6104ae60" }, "source": [ " " ] }, { "cell_type": "markdown", "id": "aad09e1a-495f-4b28-ba46-e071b6fd5b30", "metadata": { "id": "aad09e1a-495f-4b28-ba46-e071b6fd5b30" }, "source": [ "Create variables/assign values to existing variables which are dependent on their variables;" ] }, { "cell_type": "code", "execution_count": null, "id": "cfacf1ab-890f-48d8-961a-cd54e6b8fdc7", "metadata": { "id": "cfacf1ab-890f-48d8-961a-cd54e6b8fdc7" }, "outputs": [], "source": [ "\n", "adsl03 <- adsl02 %>%\n", " mutate(\n", " saffl = if_else(!is.na(trtsdt), \"Y\", \"N\"),\n", " randfl = if_else(!is.na(randdt), \"Y\", \"N\"),\n", " enrlfl = if_else(!is.na(enrldt), \"Y\", \"N\"),\n", " complfl = if_else(eosstt == \"COMPLETED\", \"Y\", \"N\", \"N\"),\n", " eotstt = if_else((eotstt == \"\" | is.na(eotstt)) & is.na(ineot) & saffl == \"Y\", \"ONGOING\", eotstt),\n", " eosstt = if_else((eosstt == \"\" | is.na(eosstt)) & is.na(ineos) & saffl == \"Y\", \"ONGOING\", eosstt),\n", " trtdurd = if_else(!is.na(trtsdt) & !is.na(trtedt), trtedt - trtsdt + 1, NA),\n", " trtdurd = as.numeric(trtdurd)\n", " )" ] }, { "cell_type": "code", "execution_count": null, "id": "b9ef2729-b997-4912-b362-9164f48ac4dd", "metadata": { "id": "b9ef2729-b997-4912-b362-9164f48ac4dd" }, "outputs": [], "source": [ "adsl03 <- adsl03 %>%\n", " mutate(across(where(is.character), ~if_else(is.na(.), \"\", .)))" ] }, { "cell_type": "markdown", "id": "4c54de88-3361-40a7-8988-7c656507505a", "metadata": { "id": "4c54de88-3361-40a7-8988-7c656507505a" }, "source": [ " " ] }, { "cell_type": "markdown", "id": "0b37712e-834c-425b-b9d0-a05aaa2d8718", "metadata": { "id": "0b37712e-834c-425b-b9d0-a05aaa2d8718" }, "source": [ "Keep only required variables;" ] }, { "cell_type": "code", "execution_count": null, "id": "e4c25775-82f5-4521-a9e7-72945ce6696f", "metadata": { "id": "e4c25775-82f5-4521-a9e7-72945ce6696f" }, "outputs": [], "source": [ "varlist <- c(\"STUDYID\", \"USUBJID\", \"SUBJID\", \"SITEID\", \"AGE\", \"AGEU\", \"AGEGR1\", \"AGEGR1N\", \"SEX\", \"RACE\", \"RACE1\", \"RACE2\", \"RACESP\", \"SAFFL\", \"COMPLFL\", \"RANDFL\", \"ENRLFL\", \"ARM\", \"ACTARM\", \"TRT01P\", \"TRT01PN\", \"TRT01A\", \"TRT01AN\", \"TRTSDT\", \"TRTEDT\", \"TR01SDT\", \"TR01EDT\", \"EOSSTT\", \"EOSDT\", \"DCSREAS\", \"EOTSTT\", \"DCTREAS\", \"RFICDT\", \"ENRLDT\", \"RANDDT\", \"LSTALVDT\", \"TRTDURD\", \"DTHDT\", \"HEIGHTBL\", \"WEIGHTBL\")\n", "\n", "adsl <- adsl03 %>%\n", " rename_all(toupper) %>%\n", " select(all_of(varlist))\n", "\n", "output<-adsl" ] }, { "cell_type": "code", "execution_count": null, "id": "d7fd1069-600e-4c71-acc1-7c39e789b554", "metadata": { "id": "d7fd1069-600e-4c71-acc1-7c39e789b554", "outputId": "1553963a-5865-4389-93bd-679664eba367" }, "outputs": [ { "data": { "text/html": [ "\n", "\n", "\n", "\t\n", "\t\n", "\n", "\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\t\n", "\n", "
A tibble: 8 × 40
STUDYIDUSUBJIDSUBJIDSITEIDAGEAGEUAGEGR1AGEGR1NSEXRACEEOTSTTDCTREASRFICDTENRLDTRANDDTLSTALVDTTRTDURDDTHDTHEIGHTBLWEIGHTBL
<chr><chr><chr><chr><dbl><chr><chr><dbl><chr><chr><chr><chr><date><date><date><date><dbl><date><dbl><dbl>
CSG001CSG001-100110011035YEARS< 60 Years 1MWHITE 2010-01-01NANA2010-01-01NANA NA NA
CSG001CSG001-100210021040YEARS< 60 Years 1FMULTIPLE 2010-01-012010-01-04NA2010-01-05NANA NA NA
CSG001CSG001-100310031040YEARS< 60 Years 1MOTHER 2010-01-012010-01-032010-01-032010-01-05NA2010-01-05 NA NA
CSG001CSG001-100410041038YEARS< 60 Years 1MWHITE COMPLETED 2010-01-012010-01-042010-01-052010-02-2821NA177.0087.3
CSG001CSG001-100510051064YEARS>= 60 Years2MAMERICAN INDIAN OR ALASKA NATIVE ONGOING 2010-01-152010-02-012010-02-052020-02-20 8NA 66.1476.1
CSG001CSG001-100610061075YEARS>= 60 Years2FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERDISCONTINUEDADVERSE EVENT 2010-02-182010-03-012010-03-012010-03-25 9NA160.0060.9
CSG001CSG001-100710071032YEARS< 60 Years 1MUNKNOWN COMPLETED 2010-04-042010-04-142010-04-142010-06-1222NA178.0085.4
CSG001CSG001-100810081083YEARS>= 60 Years2FNOT REPORTED DISCONTINUEDSUBJECT REQUEST2010-06-202010-06-262010-06-272010-08-1815NA NA NA
\n" ], "text/latex": [ "A tibble: 8 × 40\n", "\\begin{tabular}{lllllllllllllllllllll}\n", " STUDYID & USUBJID & SUBJID & SITEID & AGE & AGEU & AGEGR1 & AGEGR1N & SEX & RACE & ⋯ & EOTSTT & DCTREAS & RFICDT & ENRLDT & RANDDT & LSTALVDT & TRTDURD & DTHDT & HEIGHTBL & WEIGHTBL\\\\\n", " & & & & & & & & & & ⋯ & & & & & & & & & & \\\\\n", "\\hline\n", "\t CSG001 & CSG001-1001 & 1001 & 10 & 35 & YEARS & < 60 Years & 1 & M & WHITE & ⋯ & & & 2010-01-01 & NA & NA & 2010-01-01 & NA & NA & NA & NA\\\\\n", "\t CSG001 & CSG001-1002 & 1002 & 10 & 40 & YEARS & < 60 Years & 1 & F & MULTIPLE & ⋯ & & & 2010-01-01 & 2010-01-04 & NA & 2010-01-05 & NA & NA & NA & NA\\\\\n", "\t CSG001 & CSG001-1003 & 1003 & 10 & 40 & YEARS & < 60 Years & 1 & M & OTHER & ⋯ & & & 2010-01-01 & 2010-01-03 & 2010-01-03 & 2010-01-05 & NA & 2010-01-05 & NA & NA\\\\\n", "\t CSG001 & CSG001-1004 & 1004 & 10 & 38 & YEARS & < 60 Years & 1 & M & WHITE & ⋯ & COMPLETED & & 2010-01-01 & 2010-01-04 & 2010-01-05 & 2010-02-28 & 21 & NA & 177.00 & 87.3\\\\\n", "\t CSG001 & CSG001-1005 & 1005 & 10 & 64 & YEARS & >= 60 Years & 2 & M & AMERICAN INDIAN OR ALASKA NATIVE & ⋯ & ONGOING & & 2010-01-15 & 2010-02-01 & 2010-02-05 & 2020-02-20 & 8 & NA & 66.14 & 76.1\\\\\n", "\t CSG001 & CSG001-1006 & 1006 & 10 & 75 & YEARS & >= 60 Years & 2 & F & NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER & ⋯ & DISCONTINUED & ADVERSE EVENT & 2010-02-18 & 2010-03-01 & 2010-03-01 & 2010-03-25 & 9 & NA & 160.00 & 60.9\\\\\n", "\t CSG001 & CSG001-1007 & 1007 & 10 & 32 & YEARS & < 60 Years & 1 & M & UNKNOWN & ⋯ & COMPLETED & & 2010-04-04 & 2010-04-14 & 2010-04-14 & 2010-06-12 & 22 & NA & 178.00 & 85.4\\\\\n", "\t CSG001 & CSG001-1008 & 1008 & 10 & 83 & YEARS & >= 60 Years & 2 & F & NOT REPORTED & ⋯ & DISCONTINUED & SUBJECT REQUEST & 2010-06-20 & 2010-06-26 & 2010-06-27 & 2010-08-18 & 15 & NA & NA & NA\\\\\n", "\\end{tabular}\n" ], "text/markdown": [ "\n", "A tibble: 8 × 40\n", "\n", "| STUDYID <chr> | USUBJID <chr> | SUBJID <chr> | SITEID <chr> | AGE <dbl> | AGEU <chr> | AGEGR1 <chr> | AGEGR1N <dbl> | SEX <chr> | RACE <chr> | ⋯ ⋯ | EOTSTT <chr> | DCTREAS <chr> | RFICDT <date> | ENRLDT <date> | RANDDT <date> | LSTALVDT <date> | TRTDURD <dbl> | DTHDT <date> | HEIGHTBL <dbl> | WEIGHTBL <dbl> |\n", "|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|\n", "| CSG001 | CSG001-1001 | 1001 | 10 | 35 | YEARS | < 60 Years | 1 | M | WHITE | ⋯ | | | 2010-01-01 | NA | NA | 2010-01-01 | NA | NA | NA | NA |\n", "| CSG001 | CSG001-1002 | 1002 | 10 | 40 | YEARS | < 60 Years | 1 | F | MULTIPLE | ⋯ | | | 2010-01-01 | 2010-01-04 | NA | 2010-01-05 | NA | NA | NA | NA |\n", "| CSG001 | CSG001-1003 | 1003 | 10 | 40 | YEARS | < 60 Years | 1 | M | OTHER | ⋯ | | | 2010-01-01 | 2010-01-03 | 2010-01-03 | 2010-01-05 | NA | 2010-01-05 | NA | NA |\n", "| CSG001 | CSG001-1004 | 1004 | 10 | 38 | YEARS | < 60 Years | 1 | M | WHITE | ⋯ | COMPLETED | | 2010-01-01 | 2010-01-04 | 2010-01-05 | 2010-02-28 | 21 | NA | 177.00 | 87.3 |\n", "| CSG001 | CSG001-1005 | 1005 | 10 | 64 | YEARS | >= 60 Years | 2 | M | AMERICAN INDIAN OR ALASKA NATIVE | ⋯ | ONGOING | | 2010-01-15 | 2010-02-01 | 2010-02-05 | 2020-02-20 | 8 | NA | 66.14 | 76.1 |\n", "| CSG001 | CSG001-1006 | 1006 | 10 | 75 | YEARS | >= 60 Years | 2 | F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | ⋯ | DISCONTINUED | ADVERSE EVENT | 2010-02-18 | 2010-03-01 | 2010-03-01 | 2010-03-25 | 9 | NA | 160.00 | 60.9 |\n", "| CSG001 | CSG001-1007 | 1007 | 10 | 32 | YEARS | < 60 Years | 1 | M | UNKNOWN | ⋯ | COMPLETED | | 2010-04-04 | 2010-04-14 | 2010-04-14 | 2010-06-12 | 22 | NA | 178.00 | 85.4 |\n", "| CSG001 | CSG001-1008 | 1008 | 10 | 83 | YEARS | >= 60 Years | 2 | F | NOT REPORTED | ⋯ | DISCONTINUED | SUBJECT REQUEST | 2010-06-20 | 2010-06-26 | 2010-06-27 | 2010-08-18 | 15 | NA | NA | NA |\n", "\n" ], "text/plain": [ " STUDYID USUBJID SUBJID SITEID AGE AGEU AGEGR1 AGEGR1N SEX\n", "1 CSG001 CSG001-1001 1001 10 35 YEARS < 60 Years 1 M \n", "2 CSG001 CSG001-1002 1002 10 40 YEARS < 60 Years 1 F \n", "3 CSG001 CSG001-1003 1003 10 40 YEARS < 60 Years 1 M \n", "4 CSG001 CSG001-1004 1004 10 38 YEARS < 60 Years 1 M \n", "5 CSG001 CSG001-1005 1005 10 64 YEARS >= 60 Years 2 M \n", "6 CSG001 CSG001-1006 1006 10 75 YEARS >= 60 Years 2 F \n", "7 CSG001 CSG001-1007 1007 10 32 YEARS < 60 Years 1 M \n", "8 CSG001 CSG001-1008 1008 10 83 YEARS >= 60 Years 2 F \n", " RACE ⋯ EOTSTT DCTREAS \n", "1 WHITE ⋯ \n", "2 MULTIPLE ⋯ \n", "3 OTHER ⋯ \n", "4 WHITE ⋯ COMPLETED \n", "5 AMERICAN INDIAN OR ALASKA NATIVE ⋯ ONGOING \n", "6 NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER ⋯ DISCONTINUED ADVERSE EVENT \n", "7 UNKNOWN ⋯ COMPLETED \n", "8 NOT REPORTED ⋯ DISCONTINUED SUBJECT REQUEST\n", " RFICDT ENRLDT RANDDT LSTALVDT TRTDURD DTHDT HEIGHTBL\n", "1 2010-01-01 2010-01-01 NA NA \n", "2 2010-01-01 2010-01-04 2010-01-05 NA NA \n", "3 2010-01-01 2010-01-03 2010-01-03 2010-01-05 NA 2010-01-05 NA \n", "4 2010-01-01 2010-01-04 2010-01-05 2010-02-28 21 177.00 \n", "5 2010-01-15 2010-02-01 2010-02-05 2020-02-20 8 66.14 \n", "6 2010-02-18 2010-03-01 2010-03-01 2010-03-25 9 160.00 \n", "7 2010-04-04 2010-04-14 2010-04-14 2010-06-12 22 178.00 \n", "8 2010-06-20 2010-06-26 2010-06-27 2010-08-18 15 NA \n", " WEIGHTBL\n", "1 NA \n", "2 NA \n", "3 NA \n", "4 87.3 \n", "5 76.1 \n", "6 60.9 \n", "7 85.4 \n", "8 NA " ] }, "metadata": {}, "output_type": "display_data" } ], "source": [ "output" ] }, { "cell_type": "code", "execution_count": null, "id": "127882bf-4389-4352-a5d4-8a625982bfc4", "metadata": { "id": "127882bf-4389-4352-a5d4-8a625982bfc4" }, "outputs": [], "source": [ "save(adsl, file = \"C:/Users/Waraba/Desktop/Ckinical Trial Training Materiels/ADaM_withR/ADaM_ADSL_withR/ADaM_ADSL_L1101/adsl.RData\")" ] }, { "cell_type": "code", "execution_count": null, "id": "c57905d9-0797-4002-86bf-307b9d13105e", "metadata": { "id": "c57905d9-0797-4002-86bf-307b9d13105e", "outputId": "acb230af-0575-443e-9d27-2f5af9967b82" }, "outputs": [ { "data": { "text/html": [ "\n", "\n", "\n", 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A tibble: 8 × 40
STUDYIDUSUBJIDSUBJIDSITEIDAGEAGEUAGEGR1AGEGR1NSEXRACEEOTSTTDCTREASRFICDTENRLDTRANDDTLSTALVDTTRTDURDDTHDTHEIGHTBLWEIGHTBL
<chr><chr><chr><chr><dbl><chr><chr><dbl><chr><chr><chr><chr><date><date><date><date><dbl><date><dbl><dbl>
CSG001CSG001-100110011035YEARS< 60 Years 1MWHITE 2010-01-01NANA2010-01-01NANA NA NA
CSG001CSG001-100210021040YEARS< 60 Years 1FMULTIPLE 2010-01-012010-01-04NA2010-01-05NANA NA NA
CSG001CSG001-100310031040YEARS< 60 Years 1MOTHER 2010-01-012010-01-032010-01-032010-01-05NA2010-01-05 NA NA
CSG001CSG001-100410041038YEARS< 60 Years 1MWHITE COMPLETED 2010-01-012010-01-042010-01-052010-02-2821NA177.0087.3
CSG001CSG001-100510051064YEARS>= 60 Years2MAMERICAN INDIAN OR ALASKA NATIVE ONGOING 2010-01-152010-02-012010-02-052020-02-20 8NA 66.1476.1
CSG001CSG001-100610061075YEARS>= 60 Years2FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERDISCONTINUEDADVERSE EVENT 2010-02-182010-03-012010-03-012010-03-25 9NA160.0060.9
CSG001CSG001-100710071032YEARS< 60 Years 1MUNKNOWN COMPLETED 2010-04-042010-04-142010-04-142010-06-1222NA178.0085.4
CSG001CSG001-100810081083YEARS>= 60 Years2FNOT REPORTED DISCONTINUEDSUBJECT REQUEST2010-06-202010-06-262010-06-272010-08-1815NA NA NA
\n" ], "text/latex": [ "A tibble: 8 × 40\n", "\\begin{tabular}{lllllllllllllllllllll}\n", " STUDYID & USUBJID & SUBJID & SITEID & AGE & AGEU & AGEGR1 & AGEGR1N & SEX & RACE & ⋯ & EOTSTT & DCTREAS & RFICDT & ENRLDT & RANDDT & LSTALVDT & TRTDURD & DTHDT & HEIGHTBL & WEIGHTBL\\\\\n", " & & & & & & & & & & ⋯ & & & & & & & & & & \\\\\n", "\\hline\n", "\t CSG001 & CSG001-1001 & 1001 & 10 & 35 & YEARS & < 60 Years & 1 & M & WHITE & ⋯ & & & 2010-01-01 & NA & NA & 2010-01-01 & NA & NA & NA & NA\\\\\n", "\t CSG001 & CSG001-1002 & 1002 & 10 & 40 & YEARS & < 60 Years & 1 & F & MULTIPLE & ⋯ & & & 2010-01-01 & 2010-01-04 & NA & 2010-01-05 & NA & NA & NA & NA\\\\\n", "\t CSG001 & CSG001-1003 & 1003 & 10 & 40 & YEARS & < 60 Years & 1 & M & OTHER & ⋯ & & & 2010-01-01 & 2010-01-03 & 2010-01-03 & 2010-01-05 & NA & 2010-01-05 & NA & NA\\\\\n", "\t CSG001 & CSG001-1004 & 1004 & 10 & 38 & YEARS & < 60 Years & 1 & M & WHITE & ⋯ & COMPLETED & & 2010-01-01 & 2010-01-04 & 2010-01-05 & 2010-02-28 & 21 & NA & 177.00 & 87.3\\\\\n", "\t CSG001 & CSG001-1005 & 1005 & 10 & 64 & YEARS & >= 60 Years & 2 & M & AMERICAN INDIAN OR ALASKA NATIVE & ⋯ & ONGOING & & 2010-01-15 & 2010-02-01 & 2010-02-05 & 2020-02-20 & 8 & NA & 66.14 & 76.1\\\\\n", "\t CSG001 & CSG001-1006 & 1006 & 10 & 75 & YEARS & >= 60 Years & 2 & F & NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER & ⋯ & DISCONTINUED & ADVERSE EVENT & 2010-02-18 & 2010-03-01 & 2010-03-01 & 2010-03-25 & 9 & NA & 160.00 & 60.9\\\\\n", "\t CSG001 & CSG001-1007 & 1007 & 10 & 32 & YEARS & < 60 Years & 1 & M & UNKNOWN & ⋯ & COMPLETED & & 2010-04-04 & 2010-04-14 & 2010-04-14 & 2010-06-12 & 22 & NA & 178.00 & 85.4\\\\\n", "\t CSG001 & CSG001-1008 & 1008 & 10 & 83 & YEARS & >= 60 Years & 2 & F & NOT REPORTED & ⋯ & DISCONTINUED & SUBJECT REQUEST & 2010-06-20 & 2010-06-26 & 2010-06-27 & 2010-08-18 & 15 & NA & NA & NA\\\\\n", "\\end{tabular}\n" ], "text/markdown": [ "\n", "A tibble: 8 × 40\n", "\n", "| STUDYID <chr> | USUBJID <chr> | SUBJID <chr> | SITEID <chr> | AGE <dbl> | AGEU <chr> | AGEGR1 <chr> | AGEGR1N <dbl> | SEX <chr> | RACE <chr> | ⋯ ⋯ | EOTSTT <chr> | DCTREAS <chr> | RFICDT <date> | ENRLDT <date> | RANDDT <date> | LSTALVDT <date> | TRTDURD <dbl> | DTHDT <date> | HEIGHTBL <dbl> | WEIGHTBL <dbl> |\n", "|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|\n", "| CSG001 | CSG001-1001 | 1001 | 10 | 35 | YEARS | < 60 Years | 1 | M | WHITE | ⋯ | | | 2010-01-01 | NA | NA | 2010-01-01 | NA | NA | NA | NA |\n", "| CSG001 | CSG001-1002 | 1002 | 10 | 40 | YEARS | < 60 Years | 1 | F | MULTIPLE | ⋯ | | | 2010-01-01 | 2010-01-04 | NA | 2010-01-05 | NA | NA | NA | NA |\n", "| CSG001 | CSG001-1003 | 1003 | 10 | 40 | YEARS | < 60 Years | 1 | M | OTHER | ⋯ | | | 2010-01-01 | 2010-01-03 | 2010-01-03 | 2010-01-05 | NA | 2010-01-05 | NA | NA |\n", "| CSG001 | CSG001-1004 | 1004 | 10 | 38 | YEARS | < 60 Years | 1 | M | WHITE | ⋯ | COMPLETED | | 2010-01-01 | 2010-01-04 | 2010-01-05 | 2010-02-28 | 21 | NA | 177.00 | 87.3 |\n", "| CSG001 | CSG001-1005 | 1005 | 10 | 64 | YEARS | >= 60 Years | 2 | M | AMERICAN INDIAN OR ALASKA NATIVE | ⋯ | ONGOING | | 2010-01-15 | 2010-02-01 | 2010-02-05 | 2020-02-20 | 8 | NA | 66.14 | 76.1 |\n", "| CSG001 | CSG001-1006 | 1006 | 10 | 75 | YEARS | >= 60 Years | 2 | F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | ⋯ | DISCONTINUED | ADVERSE EVENT | 2010-02-18 | 2010-03-01 | 2010-03-01 | 2010-03-25 | 9 | NA | 160.00 | 60.9 |\n", "| CSG001 | CSG001-1007 | 1007 | 10 | 32 | YEARS | < 60 Years | 1 | M | UNKNOWN | ⋯ | COMPLETED | | 2010-04-04 | 2010-04-14 | 2010-04-14 | 2010-06-12 | 22 | NA | 178.00 | 85.4 |\n", "| CSG001 | CSG001-1008 | 1008 | 10 | 83 | YEARS | >= 60 Years | 2 | F | NOT REPORTED | ⋯ | DISCONTINUED | SUBJECT REQUEST | 2010-06-20 | 2010-06-26 | 2010-06-27 | 2010-08-18 | 15 | NA | NA | NA |\n", "\n" ], "text/plain": [ " STUDYID USUBJID SUBJID SITEID AGE AGEU AGEGR1 AGEGR1N SEX\n", "1 CSG001 CSG001-1001 1001 10 35 YEARS < 60 Years 1 M \n", "2 CSG001 CSG001-1002 1002 10 40 YEARS < 60 Years 1 F \n", "3 CSG001 CSG001-1003 1003 10 40 YEARS < 60 Years 1 M \n", "4 CSG001 CSG001-1004 1004 10 38 YEARS < 60 Years 1 M \n", "5 CSG001 CSG001-1005 1005 10 64 YEARS >= 60 Years 2 M \n", "6 CSG001 CSG001-1006 1006 10 75 YEARS >= 60 Years 2 F \n", "7 CSG001 CSG001-1007 1007 10 32 YEARS < 60 Years 1 M \n", "8 CSG001 CSG001-1008 1008 10 83 YEARS >= 60 Years 2 F \n", " RACE ⋯ EOTSTT DCTREAS \n", "1 WHITE ⋯ \n", "2 MULTIPLE ⋯ \n", "3 OTHER ⋯ \n", "4 WHITE ⋯ COMPLETED \n", "5 AMERICAN INDIAN OR ALASKA NATIVE ⋯ ONGOING \n", "6 NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER ⋯ DISCONTINUED ADVERSE EVENT \n", "7 UNKNOWN ⋯ COMPLETED \n", "8 NOT REPORTED ⋯ DISCONTINUED SUBJECT REQUEST\n", " RFICDT ENRLDT RANDDT LSTALVDT TRTDURD DTHDT HEIGHTBL\n", "1 2010-01-01 2010-01-01 NA NA \n", "2 2010-01-01 2010-01-04 2010-01-05 NA NA \n", "3 2010-01-01 2010-01-03 2010-01-03 2010-01-05 NA 2010-01-05 NA \n", "4 2010-01-01 2010-01-04 2010-01-05 2010-02-28 21 177.00 \n", "5 2010-01-15 2010-02-01 2010-02-05 2020-02-20 8 66.14 \n", "6 2010-02-18 2010-03-01 2010-03-01 2010-03-25 9 160.00 \n", "7 2010-04-04 2010-04-14 2010-04-14 2010-06-12 22 178.00 \n", "8 2010-06-20 2010-06-26 2010-06-27 2010-08-18 15 NA \n", " WEIGHTBL\n", "1 NA \n", "2 NA \n", "3 NA \n", "4 87.3 \n", "5 76.1 \n", "6 60.9 \n", "7 85.4 \n", "8 NA " ] }, "metadata": {}, "output_type": "display_data" } ], "source": [ "adsl" ] }, { "cell_type": "code", "execution_count": null, "id": "f04e12c1-4755-4349-83d9-9bac21083271", "metadata": { "id": "f04e12c1-4755-4349-83d9-9bac21083271", "outputId": "f920a2d1-fcd9-4be9-d8ec-1cc5df722530" }, "outputs": [ { "data": { "text/html": [ "\n", "
  1. 'STUDYID'
  2. 'USUBJID'
  3. 'SUBJID'
  4. 'SITEID'
  5. 'AGE'
  6. 'AGEU'
  7. 'AGEGR1'
  8. 'AGEGR1N'
  9. 'SEX'
  10. 'RACE'
  11. 'RACE1'
  12. 'RACE2'
  13. 'RACESP'
  14. 'SAFFL'
  15. 'COMPLFL'
  16. 'RANDFL'
  17. 'ENRLFL'
  18. 'ARM'
  19. 'ACTARM'
  20. 'TRT01P'
  21. 'TRT01PN'
  22. 'TRT01A'
  23. 'TRT01AN'
  24. 'TRTSDT'
  25. 'TRTEDT'
  26. 'TR01SDT'
  27. 'TR01EDT'
  28. 'EOSSTT'
  29. 'EOSDT'
  30. 'DCSREAS'
  31. 'EOTSTT'
  32. 'DCTREAS'
  33. 'RFICDT'
  34. 'ENRLDT'
  35. 'RANDDT'
  36. 'LSTALVDT'
  37. 'TRTDURD'
  38. 'DTHDT'
  39. 'HEIGHTBL'
  40. 'WEIGHTBL'
\n" ], "text/latex": [ "\\begin{enumerate*}\n", "\\item 'STUDYID'\n", "\\item 'USUBJID'\n", "\\item 'SUBJID'\n", "\\item 'SITEID'\n", "\\item 'AGE'\n", "\\item 'AGEU'\n", "\\item 'AGEGR1'\n", "\\item 'AGEGR1N'\n", "\\item 'SEX'\n", "\\item 'RACE'\n", "\\item 'RACE1'\n", "\\item 'RACE2'\n", "\\item 'RACESP'\n", "\\item 'SAFFL'\n", "\\item 'COMPLFL'\n", "\\item 'RANDFL'\n", "\\item 'ENRLFL'\n", "\\item 'ARM'\n", "\\item 'ACTARM'\n", "\\item 'TRT01P'\n", "\\item 'TRT01PN'\n", "\\item 'TRT01A'\n", "\\item 'TRT01AN'\n", "\\item 'TRTSDT'\n", "\\item 'TRTEDT'\n", "\\item 'TR01SDT'\n", "\\item 'TR01EDT'\n", "\\item 'EOSSTT'\n", "\\item 'EOSDT'\n", "\\item 'DCSREAS'\n", "\\item 'EOTSTT'\n", "\\item 'DCTREAS'\n", "\\item 'RFICDT'\n", "\\item 'ENRLDT'\n", "\\item 'RANDDT'\n", "\\item 'LSTALVDT'\n", "\\item 'TRTDURD'\n", "\\item 'DTHDT'\n", "\\item 'HEIGHTBL'\n", "\\item 'WEIGHTBL'\n", "\\end{enumerate*}\n" ], "text/markdown": [ "1. 'STUDYID'\n", "2. 'USUBJID'\n", "3. 'SUBJID'\n", "4. 'SITEID'\n", "5. 'AGE'\n", "6. 'AGEU'\n", "7. 'AGEGR1'\n", "8. 'AGEGR1N'\n", "9. 'SEX'\n", "10. 'RACE'\n", "11. 'RACE1'\n", "12. 'RACE2'\n", "13. 'RACESP'\n", "14. 'SAFFL'\n", "15. 'COMPLFL'\n", "16. 'RANDFL'\n", "17. 'ENRLFL'\n", "18. 'ARM'\n", "19. 'ACTARM'\n", "20. 'TRT01P'\n", "21. 'TRT01PN'\n", "22. 'TRT01A'\n", "23. 'TRT01AN'\n", "24. 'TRTSDT'\n", "25. 'TRTEDT'\n", "26. 'TR01SDT'\n", "27. 'TR01EDT'\n", "28. 'EOSSTT'\n", "29. 'EOSDT'\n", "30. 'DCSREAS'\n", "31. 'EOTSTT'\n", "32. 'DCTREAS'\n", "33. 'RFICDT'\n", "34. 'ENRLDT'\n", "35. 'RANDDT'\n", "36. 'LSTALVDT'\n", "37. 'TRTDURD'\n", "38. 'DTHDT'\n", "39. 'HEIGHTBL'\n", "40. 'WEIGHTBL'\n", "\n", "\n" ], "text/plain": [ " [1] \"STUDYID\" \"USUBJID\" \"SUBJID\" \"SITEID\" \"AGE\" \"AGEU\" \n", " [7] \"AGEGR1\" \"AGEGR1N\" \"SEX\" \"RACE\" \"RACE1\" \"RACE2\" \n", "[13] \"RACESP\" \"SAFFL\" \"COMPLFL\" \"RANDFL\" \"ENRLFL\" \"ARM\" \n", "[19] \"ACTARM\" \"TRT01P\" \"TRT01PN\" \"TRT01A\" \"TRT01AN\" \"TRTSDT\" \n", "[25] \"TRTEDT\" \"TR01SDT\" \"TR01EDT\" \"EOSSTT\" \"EOSDT\" \"DCSREAS\" \n", "[31] \"EOTSTT\" \"DCTREAS\" \"RFICDT\" \"ENRLDT\" \"RANDDT\" \"LSTALVDT\"\n", "[37] \"TRTDURD\" \"DTHDT\" \"HEIGHTBL\" \"WEIGHTBL\"" ] }, "metadata": {}, "output_type": "display_data" } ], "source": [ "colnames(adsl)" ] }, { "cell_type": "code", "execution_count": null, "id": "44c118b3-10f4-46df-aeae-2d37f4167684", "metadata": { "id": "44c118b3-10f4-46df-aeae-2d37f4167684" }, "outputs": [], "source": [] } ], "metadata": { "kernelspec": { "display_name": "R", "language": "R", "name": "ir" }, "language_info": { "codemirror_mode": "r", "file_extension": ".r", "mimetype": "text/x-r-source", "name": "R", "pygments_lexer": "r", "version": "4.2.1" }, "colab": { "provenance": [], "include_colab_link": true } }, "nbformat": 4, "nbformat_minor": 5 }