From 8a73f2bc2ffc7ccaec304976df965e23a0b408de Mon Sep 17 00:00:00 2001 From: Joel Laxamana Date: Fri, 22 Mar 2024 19:11:26 +0000 Subject: [PATCH] ran as a production run in main, which will now be used to copy over into the pilot3-adam-to-fda repo --- submission/adam/adadas.xpt | Bin 4218880 -> 4218880 bytes submission/adam/adae.xpt | Bin 714800 -> 714800 bytes submission/adam/adlbc.xpt | Bin 14303040 -> 14303040 bytes submission/adam/adsl.xpt | Bin 117840 -> 117840 bytes submission/adam/adtte.xpt | Bin 73520 -> 73520 bytes submission/output/tlf-demographic-pilot3.out | 2 +- submission/output/tlf-efficacy-pilot3.rtf | 2 +- submission/output/tlf-kmplot-pilot3.pdf | Bin 10929 -> 10929 bytes submission/output/tlf-primary-pilot3.rtf | 2 +- vignettes/adrg.pdf | Bin 552227 -> 552189 bytes vignettes/adrg.qmd | 60 ++++--------------- 11 files changed, 16 insertions(+), 50 deletions(-) diff --git a/submission/adam/adadas.xpt b/submission/adam/adadas.xpt index 11f78ca636ea22b7af1513b8ca4940f7f3c8dbdd..bf55071cb5f9bdd40ccbda628b69325d01a6cd34 100644 GIT binary patch delta 343 zcmajVw++Hj002?hEpRBwBNqnx3~A}?{=}It0jHOu)z)ooN&Pn54`Zfj{t%QK|vT1L=i(A z2_%t18X07fLmmYbp`wH`DyX7{IvQxAg*H0qqK7^P7-9s0F(#N|1`Ts8pks*@*4SYC Ju%w-G`T!KFe@g%W delta 343 zcmajVw++Go002RmoO8}OCmVwU!3YV)U=|Pstvw1AEvqmA9)YK&p}69uKR+*yGfcBK z(~gI|B;3w>U2WlJ3ttX6;es0;c;SN|0R$037!gDfLmUYtkwO|7 zWRXK21r$+285LAfLmdq?(Lx&?bkRc}0}L_37!yn}g9r(8$XH+r1u8V?SYeF~wlE&H Hu#25Oyg7dV diff --git a/submission/adam/adae.xpt b/submission/adam/adae.xpt index 890a0c9a3b6e94c7c2431893c2413e4b834c18c8..dfa09301e29d7dbb5bffd8479b1e96652653a1c0 100644 GIT binary patch delta 123 zcmdmRL3_gm?Fkd*jeH%0j7+Qy&8>`q$iN7VKXIe|#P^Q~scQbf*#3bLgqeVt8Hibc Wm=%cGfS4VKIe?gR`v*oYhi3p;O(+@w delta 123 zcmdmRL3_gm?Fkd*O&vqsjf|}fEvyU;t&EI}(D)NK+E0A{h>)u04~*>}7(ti`h?#+y Y1&CRJm<@>8ftUk`Ik$gc6+5sSyYk?a`Ar|AFJ@)su&B zcXnp8e*X;5B0UrtOioG(#>7X(#z)7=;6FQ*kr?{*<3C=hfv~hdST_E4c5;xDaB`8G zJme)G`6)m_3Q?E{icpkd6sH6wDMe|@P?mC(rvi~wq!N{>LRG3!of_1n7PYBEUFuPv z01b#DNHj4tq!F>i(U^Fe(3Aw4kw|lrXhBO_(V8~2r5)|*Ku0=}OlP{#m2RZaogVb0 z7rp62U;5FX0SsgigBik5hB2HGjARs}8N*n{F`fxbWD=8^!c?X)of*tz7PFbdT;?&K z1uSF{i&?@_mXXSGRA{i%`k1B?(UwNHr?GWUAglgI3BmITs-G@ z-gDlp-#^2%NDoEECZ!}tMaKu@;)B8Xm|)aDJCuKUa5hwv_M!k{x&-~$VoW4 z$W0#dl8^ippdf`POaw(JN->I4f|8V?G-W7DIm%OkNGei^%2c5$)u>JlYEp~Z)S)i* zs84_f1c@S=7-DHiBjRXGJWXgy0?kOIIZ3pjC9P;p8Q6 zq|l4r^r0{P=+6KKGKj$pVJO2G&Im>_iqVW=EaMo@1ST?x$xLA?)0oZ-W-^P}%waC` zn9l+hvWUejVJXWjA{htV|4y(D)NK+E0A{h>)u04~*MCFft~b0sw@P B8aMy| delta 87 zcmcaGgZ;t`_6ZZ^O&vqsjf|}fEvyU;tqe_!(D)NK+E0A{h>)u04~*MCFft~b0sw%z B8Xy1w diff --git a/submission/adam/adtte.xpt b/submission/adam/adtte.xpt index af2636bffc4772c4b7074c75918a5c75d4d23a4e..7d76c4122756fdd68845c8c5ad52a50895abdff6 100644 GIT binary patch delta 87 zcmdn6k7dI?mI)K(jeH%0j7+Qy&8>_rtc*>J(D)NK+E0A{h>)u04~*MCFfuyG0sx3! B8HE4< delta 87 zcmdn6k7dI?mI)K(O&vqsjf|}fEvyWUtPG5d(D)NK+E0A{h>)u04~*MCFfuyG0sw$+ B8BqWL diff --git a/submission/output/tlf-demographic-pilot3.out b/submission/output/tlf-demographic-pilot3.out index 7e3b807..4cd5c5f 100644 --- a/submission/output/tlf-demographic-pilot3.out +++ b/submission/output/tlf-demographic-pilot3.out @@ -36,5 +36,5 @@ MMSE Total ————————————————————————————————————————————————————————————————————————————————————————————————— Program: tlf-demographic.r -2023-08-25 19:50:33 +2024-03-22 17:39:02 diff --git a/submission/output/tlf-efficacy-pilot3.rtf b/submission/output/tlf-efficacy-pilot3.rtf index 62f9452..d166f75 100644 --- a/submission/output/tlf-efficacy-pilot3.rtf +++ b/submission/output/tlf-efficacy-pilot3.rtf @@ -127,7 +127,7 @@ \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrdb\brdrw15\clvertalt\cellx9000 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0 Root Mean Squared Error of Change = 1.30}\cell \intbl\row\pard -{\pard\hyphpar\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Table generated on: 2023-08-25 19:46:40}\par} +{\pard\hyphpar\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Table generated on: 2024-03-22 17:39:12}\par} {\pard\hyphpar\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Source: [pilot3: adam-adsl; adlbc]}\par} diff --git a/submission/output/tlf-kmplot-pilot3.pdf b/submission/output/tlf-kmplot-pilot3.pdf index 50fde124b8b8949d24f93a898a890e2625111064..a0a5177106b130656c1b621064cdeb34fadad836 100644 GIT binary patch delta 82 zcmdlOx-oQuiJFOlv5}FXxv{08g(jE2Z+?nPVo9okhKrSvfe}J(W0bj+^!D@DK1jYS gncx1nc>4aI|Nkxdm;dk1UwwWyy@#9ENU;h40Bp}7Qvd(} delta 82 zcmdlOx-oQuiJGy2g^{VDrKy3jg(jE2Z+?nPVo9okhKrSvfe}J(W0bj+^x^buH^mdO f^N)Z1yrKT{|G%Dp@Bi8PJ6`CB-jmI1q*w(2P9Puu diff --git a/submission/output/tlf-primary-pilot3.rtf b/submission/output/tlf-primary-pilot3.rtf index ead26f5..2e618e8 100644 --- a/submission/output/tlf-primary-pilot3.rtf +++ b/submission/output/tlf-primary-pilot3.rtf @@ -59,7 +59,7 @@ {\f1\fs20\i [3] Pairwise 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+|-----------------------------|-----------------------------------------------| | SDTM | SDTM Implementation Guide Version 3.1.2 | -+-----------------------------+-----------------------------------------------+ | | SDTM Version 1.2 | -+-----------------------------+-----------------------------------------------+ | | | -+-----------------------------+-----------------------------------------------+ | SDTM Controlled Terminology | CDISC SDTM Controlled Terminology, 2022-12-16 | -+-----------------------------+-----------------------------------------------+ | | | -+-----------------------------+-----------------------------------------------+ | ADaM | ADaM-IG v1.1 | -+-----------------------------+-----------------------------------------------+ | | ADaM v2.1 | -+-----------------------------+-----------------------------------------------+ | | | -+-----------------------------+-----------------------------------------------+ | ADaM Controlled Terminology | CDISC ADaM Controlled Terminology, 2022-06-24 | -+-----------------------------+-----------------------------------------------+ | | | -+-----------------------------+-----------------------------------------------+ | Data Definitions | Define-XML v2.0 | -+-----------------------------+-----------------------------------------------+ | | | -+-----------------------------+-----------------------------------------------+ | Medical Events Dictionary | MedDRA version 8.0 | -+-----------------------------+-----------------------------------------------+ ## Source Data Used for Analysis Dataset Creation @@ -279,11 +265,9 @@ Was define.xml evaluated? ## Issues Summary -+----------+------------------------------------------------------------------------------+---------+--------------------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | Check ID | Diagnostic Message | Dataset | Count (Issue Rate) | Explanation | -+==========+==============================================================================+=========+====================+=========================================================================================================================================================================================+ +|----------|------------------------------------------------------------------------------|---------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AD1012 | Secondary custom variable is present but its primary variable is not present | ADSL | 1 (50.00%) | This is a Sponsor Extension to the ADaM Model. The VISNUMEN \[End of Trt Visit (Vis 12 or Early Term.)\] variable is a integer variable which is not related to any character variable. | -+----------+------------------------------------------------------------------------------+---------+--------------------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ : {tbl-colwidths="\[17,22,15,22,25\]"} @@ -303,19 +287,13 @@ The sponsor has provided all programs for analysis results. They are all created The following table contains the list of programs that generate the analysis datasets in Pilot 3. It shows the program file name, the analysis dataset name and the label of the analysis dataset. The recommended steps to execute the analysis results using R are described in the Appendix. -+------------------+---------------------------+--------------------------------------+ | **Program Name** | **Analysis Dataset Name** | **Analysis Dataset Label** | -+==================+===========================+======================================+ +|------------------|---------------------------|--------------------------------------| | adsl.r | adsl.xpt | Subject-Level Analysis Dataset | -+------------------+---------------------------+--------------------------------------+ | adadas.r | adas.xpt | ADAS-Cog Analysis | -+------------------+---------------------------+--------------------------------------+ | adlbc.r | adlb.xpt | Analysis Dataset Lab Blood Chemistry | -+------------------+---------------------------+--------------------------------------+ | adae.r | adae.xpt | Adverse Events Analysis Dataset | -+------------------+---------------------------+--------------------------------------+ | adtte.r | adtte.xpt | AE Time to 1st Derm. Event Analysis | -+------------------+---------------------------+--------------------------------------+ ## Analysis Output Programs @@ -363,17 +341,12 @@ The following table contains a list of programs that generate outputs used in th For reference, below is a description of the analysis programs utilized and outputs generated in Pilot 1. -+-------------------+-------------------------+-----------------------------------------------------------------------------------+ | **Program Name** | **Output Table Number** | **Title** | -+===================+=========================+===================================================================================+ +|-------------------|-------------------------|-----------------------------------------------------------------------------------| | tlf-demographic.r | Table 14-2.01 | Summary of Demographic and Baseline Characteristics | -+-------------------+-------------------------+-----------------------------------------------------------------------------------+ | tlf-primary.r | Table 14-3.01 | Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF | -+-------------------+-------------------------+-----------------------------------------------------------------------------------+ | tlf-efficacy.r | Table 14-3.02 | ANCOVA of Change from Baseline at Week 20 | -+-------------------+-------------------------+-----------------------------------------------------------------------------------+ | tlf-kmplot.r | Figure 14-1 | KM plot for Time to First Dermatologic Event: Safety population | -+-------------------+-------------------------+-----------------------------------------------------------------------------------+ ## Proprietary R Packages @@ -661,7 +634,7 @@ A minimum set of R packages are required to ensure the Pilot 3 analysis programs - If after selecting option 1, you may receive a warning such as : -``` +``` Warning: error downloading 'https://packagemanager.posit.co/cran/2023-03-15/bin/windows/contrib/4.2/ PACKAGES.rds' @@ -1126,21 +1099,14 @@ First 10 of 20 rows are shown in table below In pilot3, variable labels were updated per ADaM IG 1.1, which caused some discrepancies with original CDISC pilot data label. -+------------+------------+---------------------------------+------------------------------------+ -| Dataset | Variable | CDISC pilot data label | Pilot3 label | -+:===========+:===========+:================================+:===================================+ -| ADAE | ADURN | Analysis Duration (N) | AE Duration (N) | -+------------+------------+---------------------------------+------------------------------------+ -| | ADURU | Analysis Duration Units | AE Duration Units | -+------------+------------+---------------------------------+------------------------------------+ -| | AOCCFL | 1st Occurrence of Any AE Flag | 1st Occurrence within Subject Flag | -+------------+------------+---------------------------------+------------------------------------+ -| ADADAS | ANL01FL | Analysis Record Flag 01 | Analysis Flag 01 | -+------------+------------+---------------------------------+------------------------------------+ -| | ITTFL | Intent-to-Treat Population Flag | Intent-To-Treat Population Flag | -+------------+------------+---------------------------------+------------------------------------+ -| ADTTE | SRCDOM | Source Data | Source Domain | -+------------+------------+---------------------------------+------------------------------------+ +| Dataset | Variable | CDISC pilot data label | Pilot3 label | +|:--------|:---------|:--------------------------------|:-----------------------------------| +| ADAE | ADURN | Analysis Duration (N) | AE Duration (N) | +| | ADURU | Analysis Duration Units | AE Duration Units | +| | AOCCFL | 1st Occurrence of Any AE Flag | 1st Occurrence within Subject Flag | +| ADADAS | ANL01FL | Analysis Record Flag 01 | Analysis Flag 01 | +| | ITTFL | Intent-to-Treat Population Flag | Intent-To-Treat Population Flag | +| ADTTE | SRCDOM | Source Data | Source Domain | {{< pagebreak >}}