diff --git a/book/generate-index.R b/book/generate-index.R index 2fd8e3c71a..927a0df5c8 100755 --- a/book/generate-index.R +++ b/book/generate-index.R @@ -37,32 +37,32 @@ cat( # Tables section_header("Tables") -create_subsection("./tables/ada", "ADA") +create_subsection("./tables/ADA", "ADA") create_subsection("./tables/adverse-events", "Adverse Events") -create_subsection("./tables/con-med", "Concomitant Medications") +create_subsection("./tables/concomitant-medications", "Concomitant Medications") create_subsection("./tables/deaths", "Deaths") create_subsection("./tables/demography", "Demography") create_subsection("./tables/disclosures", "Disclosures") create_subsection("./tables/disposition", "Disposition") -create_subsection("./tables/ecg", "ECG") +create_subsection("./tables/ECG", "ECG") create_subsection("./tables/efficacy", "Efficacy") create_subsection("./tables/exposure", "Exposure") create_subsection("./tables/lab-results", "Lab Results") create_subsection("./tables/medical-history", "Medical History") create_subsection("./tables/pharmacokinetic", "Pharmacokinetic") -create_subsection("./tables/rmp", "Risk Management Plan") +create_subsection("./tables/risk-management-plan", "Risk Management Plan") create_subsection("./tables/safety", "Safety") create_subsection("./tables/vital-signs", "Vital Signs") # Listings section_header("Listings") -create_subsection("./listings/ada", "ADA") +create_subsection("./listings/ADA", "ADA") create_subsection("./listings/adverse-events", "Adverse Events") -create_subsection("./listings/con-med", "Concomitant Medications") +create_subsection("./listings/concomitant-medications", "Concomitant Medications") # nolint create_subsection("./listings/disposition", "Disposition") -create_subsection("./listings/dsur", "Development Safety Update Report") -create_subsection("./listings/ecg", "ECG") +create_subsection("./listings/development-safety-update-report", "Development Safety Update Report") # nolint +create_subsection("./listings/ECG", "ECG") create_subsection("./listings/exposure", "Exposure") create_subsection("./listings/lab-results", "Lab Results") create_subsection("./listings/medical-history", "Medical History") diff --git a/book/listings/ada/adal02.qmd b/book/listings/ADA/adal02.qmd similarity index 100% rename from book/listings/ada/adal02.qmd rename to book/listings/ADA/adal02.qmd diff --git a/book/listings/ecg/egl01.qmd b/book/listings/ECG/egl01.qmd similarity index 100% rename from book/listings/ecg/egl01.qmd rename to book/listings/ECG/egl01.qmd diff --git a/book/listings/con-med/cml01.qmd b/book/listings/concomitant-medications/cml01.qmd similarity index 100% rename from book/listings/con-med/cml01.qmd rename to book/listings/concomitant-medications/cml01.qmd diff --git a/book/listings/con-med/cml02a_gl.qmd b/book/listings/concomitant-medications/cml02a_gl.qmd similarity index 100% rename from book/listings/con-med/cml02a_gl.qmd rename to book/listings/concomitant-medications/cml02a_gl.qmd diff --git a/book/listings/con-med/cml02b_gl.qmd b/book/listings/concomitant-medications/cml02b_gl.qmd similarity index 100% rename from book/listings/con-med/cml02b_gl.qmd rename to book/listings/concomitant-medications/cml02b_gl.qmd diff --git a/book/listings/dsur/dsur4.qmd b/book/listings/development-safety-update-report/dsur4.qmd similarity index 100% rename from book/listings/dsur/dsur4.qmd rename to book/listings/development-safety-update-report/dsur4.qmd diff --git a/book/tables/ada/adat01.qmd b/book/tables/ADA/adat01.qmd similarity index 100% rename from book/tables/ada/adat01.qmd rename to book/tables/ADA/adat01.qmd diff --git a/book/tables/ada/adat02.qmd b/book/tables/ADA/adat02.qmd similarity index 100% rename from book/tables/ada/adat02.qmd rename to book/tables/ADA/adat02.qmd diff --git a/book/tables/ada/adat03.qmd b/book/tables/ADA/adat03.qmd similarity index 100% rename from book/tables/ada/adat03.qmd rename to book/tables/ADA/adat03.qmd diff --git a/book/tables/ada/adat04a.qmd b/book/tables/ADA/adat04a.qmd similarity index 100% rename from book/tables/ada/adat04a.qmd rename to book/tables/ADA/adat04a.qmd diff --git a/book/tables/ada/adat04b.qmd b/book/tables/ADA/adat04b.qmd similarity index 100% rename from book/tables/ada/adat04b.qmd rename to book/tables/ADA/adat04b.qmd diff --git a/book/tables/ecg/egt01.qmd b/book/tables/ECG/egt01.qmd similarity index 100% rename from book/tables/ecg/egt01.qmd rename to book/tables/ECG/egt01.qmd diff --git a/book/tables/ecg/egt02.qmd b/book/tables/ECG/egt02.qmd similarity index 100% rename from book/tables/ecg/egt02.qmd rename to book/tables/ECG/egt02.qmd diff --git a/book/tables/ecg/egt03.qmd b/book/tables/ECG/egt03.qmd similarity index 100% rename from book/tables/ecg/egt03.qmd rename to book/tables/ECG/egt03.qmd diff --git a/book/tables/ecg/egt04.qmd b/book/tables/ECG/egt04.qmd similarity index 100% rename from book/tables/ecg/egt04.qmd rename to book/tables/ECG/egt04.qmd diff --git a/book/tables/ecg/egt05_qtcat.qmd b/book/tables/ECG/egt05_qtcat.qmd similarity index 100% rename from book/tables/ecg/egt05_qtcat.qmd rename to book/tables/ECG/egt05_qtcat.qmd diff --git a/book/tables/con-med/cmt01.qmd b/book/tables/concomitant-medications/cmt01.qmd similarity index 100% rename from book/tables/con-med/cmt01.qmd rename to book/tables/concomitant-medications/cmt01.qmd diff --git a/book/tables/con-med/cmt01a.qmd b/book/tables/concomitant-medications/cmt01a.qmd similarity index 100% rename from book/tables/con-med/cmt01a.qmd rename to book/tables/concomitant-medications/cmt01a.qmd diff --git a/book/tables/con-med/cmt01b.qmd b/book/tables/concomitant-medications/cmt01b.qmd similarity index 100% rename from book/tables/con-med/cmt01b.qmd rename to book/tables/concomitant-medications/cmt01b.qmd diff --git a/book/tables/con-med/cmt02_pt.qmd b/book/tables/concomitant-medications/cmt02_pt.qmd similarity index 100% rename from book/tables/con-med/cmt02_pt.qmd rename to book/tables/concomitant-medications/cmt02_pt.qmd diff --git a/book/tables/rmp/rmpt01.qmd b/book/tables/risk-management-plan/rmpt01.qmd similarity index 100% rename from book/tables/rmp/rmpt01.qmd rename to book/tables/risk-management-plan/rmpt01.qmd diff --git a/book/tables/rmp/rmpt03.qmd b/book/tables/risk-management-plan/rmpt03.qmd similarity index 100% rename from book/tables/rmp/rmpt03.qmd rename to book/tables/risk-management-plan/rmpt03.qmd diff --git a/book/tables/rmp/rmpt04.qmd b/book/tables/risk-management-plan/rmpt04.qmd similarity index 100% rename from book/tables/rmp/rmpt04.qmd rename to book/tables/risk-management-plan/rmpt04.qmd diff --git a/book/tables/rmp/rmpt05.qmd b/book/tables/risk-management-plan/rmpt05.qmd similarity index 100% rename from book/tables/rmp/rmpt05.qmd rename to book/tables/risk-management-plan/rmpt05.qmd diff --git a/book/tables/rmp/rmpt06.qmd b/book/tables/risk-management-plan/rmpt06.qmd similarity index 100% rename from book/tables/rmp/rmpt06.qmd rename to book/tables/risk-management-plan/rmpt06.qmd diff --git a/book/tlg-index.qmd b/book/tlg-index.qmd index 51b0c6ca53..8d0efa650c 100644 --- a/book/tlg-index.qmd +++ b/book/tlg-index.qmd @@ -8,6 +8,19 @@ toc-depth: 4 ### **Tables** +#### ADA + +        [ADAT01 -- Baseline Prevalence and Incidence of Treatment Emergent ADA](./tables/ADA/adat01.qmd) + +        [ADAT02 -- Summary of Patients with Treatment-Induced ADA](./tables/ADA/adat02.qmd) + +        [ADAT03 -- Summary of Serum Concentrations at Timepoints Where ADA Samples Were Collected and Analyzed](./tables/ADA/adat03.qmd) + +        [ADAT04A -- Baseline Prevalence and Incidence of Treatment Emergent NAbs](./tables/ADA/adat04a.qmd) + +        [ADAT04B -- Baseline Prevalence and Incidence of NAbs](./tables/ADA/adat04b.qmd) + + #### Adverse Events         [AET01 -- Safety Summary](./tables/adverse-events/aet01.qmd) @@ -41,12 +54,70 @@ toc-depth: 4         [AET10 -- Most Common ($\geq$ 5%) Adverse Events](./tables/adverse-events/aet10.qmd) +#### Concomitant Medications + +        [CMT01 -- Concomitant Medications (GNEDrug Legacy Coding)](./tables/concomitant-medications/cmt01.qmd) + +        [CMT01A -- Concomitant Medications by Medication Class and Preferred Name](./tables/concomitant-medications/cmt01a.qmd) + +        [CMT01B -- Concomitant Medications by Medication Class and Preferred Name](./tables/concomitant-medications/cmt01b.qmd) + +        [CMT02_PT -- Concomitant Medications by Preferred Name (WHODrug Coding)](./tables/concomitant-medications/cmt02_pt.qmd) + + +#### Deaths + +        [DTHT01 -- Deaths](./tables/deaths/dtht01.qmd) + + +#### Demography + +        [DMT01 -- Demographics and Baseline Characteristics](./tables/demography/dmt01.qmd) + + +#### Disclosures + +        [DISCLOSUREST01 -- Disclosures Outputs](./tables/disclosures/disclosurest01.qmd) + +        [EUDRAT01 -- Non-Serious Adverse Events Reported in $\geq$ 5% of Patients in Any Treatment Group -- Patients and Events](./tables/disclosures/eudrat01.qmd) + +        [EUDRAT02 -- Serious Adverse Events, Fatal Serious Adverse Events, and Serious Adverse Events Related to Study Medication](./tables/disclosures/eudrat02.qmd) + + +#### Disposition + +        [DST01 -- Patient Disposition](./tables/disposition/dst01.qmd) + +        [PDT01 -- Major Protocol Deviations](./tables/disposition/pdt01.qmd) + +        [PDT02 -- Major Protocol Deviations Related to Epidemic/Pandemic](./tables/disposition/pdt02.qmd) + + +#### ECG + +        [EGT01 -- ECG Results and Change from Baseline by Visit](./tables/ECG/egt01.qmd) + +        [EGT02 -- ECG Abnormalities (EGT02_1 & EGT02_2)](./tables/ECG/egt02.qmd) + +        [EGT03 -- Shift Table of ECG Interval Data -- Baseline Versus Minimum/Maximum Post-Baseline](./tables/ECG/egt03.qmd) + +        [EGT04 -- Shift Table of Qualitative ECG Assessments](./tables/ECG/egt04.qmd) + +        [EGT05_QTCAT -- ECG Actual Values and Changes from Baseline by Visit](./tables/ECG/egt05_qtcat.qmd) + + #### Efficacy         [AOVT01 -- ANCOVA for Multiple End Points](./tables/efficacy/aovt01.qmd) +        [AOVT02 -- ANCOVA with Single End Point and Customized Table](./tables/efficacy/aovt02.qmd) + +        [AOVT03 -- ANCOVA with Consideration of Interaction](./tables/efficacy/aovt03.qmd) +         [CFBT01 -- Efficacy Data and Change from Baseline by Visit](./tables/efficacy/cfbt01.qmd) +        [CMHT01 -- Cochran-Mantel-Haenszel (CMH) Summary](./tables/efficacy/cmht01.qmd) +         [COXT01 -- Cox Regression](./tables/efficacy/coxt01.qmd)         [COXT02 -- Multivariable Cox Regression](./tables/efficacy/coxt02.qmd) @@ -59,11 +130,20 @@ toc-depth: 4         [ONCT05 -- Objective Response Rate by Subgroup](./tables/efficacy/onct05.qmd) +        [RATET01 -- Event Rate Summary for Recurrent Events](./tables/efficacy/ratet01.qmd) + +        [RBMIT01 -- Tables for RBMI](./tables/efficacy/rbmit01.qmd) +         [RSPT01 -- Best Overall Response](./tables/efficacy/rspt01.qmd)         [TTET01 -- Time-To-Event Summary](./tables/efficacy/ttet01.qmd) +#### Exposure + +        [EXT01 -- Study Drug Exposure Table](./tables/exposure/ext01.qmd) + + #### Lab Results         [LBT01 -- Laboratory Test Results and Change from Baseline by Visit](./tables/lab-results/lbt01.qmd) @@ -103,17 +183,12 @@ toc-depth: 4         [LBT15 -- Laboratory Test Shifts to NCI CTCAE Grade 3-4 Post-Baseline](./tables/lab-results/lbt15.qmd) -#### Pharmacokinetic - -        [ADAT01 -- Baseline Prevalence and Incidence of Treatment Emergent ADA](./tables/pharmacokinetic/adat01.qmd) - -        [ADAT02 -- Summary of Patients with Treatment-Induced ADA](./tables/pharmacokinetic/adat02.qmd) +#### Medical History -        [ADAT03 -- Summary of Serum Concentrations at Timepoints Where ADA Samples Were Collected and Analyzed](./tables/pharmacokinetic/adat03.qmd) +        [MHT01 -- Medical History](./tables/medical-history/mht01.qmd) -        [ADAT04A -- Baseline Prevalence and Incidence of Treatment Emergent NAbs](./tables/pharmacokinetic/adat04a.qmd) -        [ADAT04B -- Baseline Prevalence and Incidence of NAbs](./tables/pharmacokinetic/adat04b.qmd) +#### Pharmacokinetic         [PKCT01 -- Summary Concentration Table](./tables/pharmacokinetic/pkct01.qmd) @@ -134,145 +209,136 @@ toc-depth: 4         [PKPT11 -- Pharmacokinetic Parameter Estimated Ratios of Geometric Means and 90% Confidence Intervals for AUC and CMAX](./tables/pharmacokinetic/pkpt11.qmd) -#### Safety +#### Risk Management Plan -        [CMT01 -- Concomitant Medications (GNEDrug Legacy Coding)](./tables/safety/cmt01.qmd) +        [RMPT01 -- Duration of Exposure for Risk Management Plan](./tables/risk-management-plan/rmpt01.qmd) -        [CMT01A -- Concomitant Medications by Medication Class and Preferred Name](./tables/safety/cmt01a.qmd) +        [RMPT03 -- Extent of Exposure by Age Group and Gender for Risk Management Plan](./tables/risk-management-plan/rmpt03.qmd) -        [CMT01B -- Concomitant Medications by Medication Class and Preferred Name](./tables/safety/cmt01b.qmd) +        [RMPT04 -- Extent of Exposure by Ethnic Origin for Risk Management Plan](./tables/risk-management-plan/rmpt04.qmd) -        [CMT02_PT -- Concomitant Medications by Preferred Name (WHODrug Coding)](./tables/safety/cmt02_pt.qmd) +        [RMPT05 -- Extent of Exposure by Race for Risk Management Plan](./tables/risk-management-plan/rmpt05.qmd) -        [DMT01 -- Demographics and Baseline Characteristics](./tables/safety/dmt01.qmd) +        [RMPT06 -- Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan](./tables/risk-management-plan/rmpt06.qmd) -        [DST01 -- Patient Disposition](./tables/safety/dst01.qmd) -        [DTHT01 -- Deaths](./tables/safety/dtht01.qmd) +#### Safety -        [EGT01 -- ECG Results and Change from Baseline by Visit](./tables/safety/egt01.qmd) +        [ENTXX -- Enrollment Variants](./tables/safety/enrollment01.qmd) -        [EGT02 -- ECG Abnormalities (EGT02_1 & EGT02_2)](./tables/safety/egt02.qmd) -        [EGT03 -- Shift Table of ECG Interval Data -- Baseline Versus Minimum/Maximum Post-Baseline](./tables/safety/egt03.qmd) +#### Vital Signs -        [EGT04 -- Shift Table of Qualitative ECG Assessments](./tables/safety/egt04.qmd) +        [VST01 -- Vital Sign Results and Change from Baseline by Visit](./tables/vital-signs/vst01.qmd) -        [EGT05_QTCAT -- ECG Actual Values and Changes from Baseline by Visit](./tables/safety/egt05_qtcat.qmd) +        [VST02 -- Vital Sign Abnormalities](./tables/vital-signs/vst02.qmd) -        [ENTXX -- Enrollment Variants](./tables/safety/enrollment01.qmd) -        [EUDRAT01 -- Non-Serious Adverse Events Reported in $\geq$ 5% of Patients in Any Treatment Group -- Patients and Events](./tables/safety/eudrat01.qmd) +------------------------------------------------------------------------ -        [EUDRAT02 -- Serious Adverse Events, Fatal Serious Adverse Events, and Serious Adverse Events Related to Study Medication](./tables/safety/eudrat02.qmd) +### **Listings** -        [EXT01 -- Study Drug Exposure Table](./tables/safety/ext01.qmd) +#### ADA -        [MHT01 -- Medical History](./tables/safety/mht01.qmd) +        [ADAL02 -- Listing of Anti-Drug Antibody Data for Treatment Emergent ADA Positive Patients](./listings/ADA/adal02.qmd) -        [PDT01 -- Major Protocol Deviations](./tables/safety/pdt01.qmd) -        [PDT02 -- Major Protocol Deviations Related to Epidemic/Pandemic](./tables/safety/pdt02.qmd) +#### Adverse Events -        [VST01 -- Vital Sign Results and Change from Baseline by Visit](./tables/safety/vst01.qmd) +        [AEL01 -- Listing of Preferred Terms, Lowest Level Terms, and Investigator-Specified Adverse Event Terms](./listings/adverse-events/ael01.qmd) -        [VST02 -- Vital Sign Abnormalities](./tables/safety/vst02.qmd) +        [AEL01_NOLLT -- Listing of Preferred Terms and Investigator-Specified Adverse Event Terms](./listings/adverse-events/ael01_nollt.qmd) +        [AEL02 -- Listing of Adverse Events](./listings/adverse-events/ael02.qmd) -#### Other +        [AEL02_ED -- Listing of Adverse Events (for Early Development Studies)](./listings/adverse-events/ael02_ed.qmd) -        [AOVT02 -- ANCOVA with Single End Point and Customized Table](./tables/other/aovt02.qmd) +        [AEL03 -- Listing of Serious Adverse Events](./listings/adverse-events/ael03.qmd) -        [AOVT03 -- ANCOVA with Consideration of Interaction](./tables/other/aovt03.qmd) +        [AEL04 -- Listing of Patient Deaths](./listings/adverse-events/ael04.qmd) -        [CMHT01 -- Cochran-Mantel-Haenszel (CMH) Summary](./tables/other/cmht01.qmd) -        [DISCLOSUREST01 -- Disclosures Outputs](./tables/other/disclosurest01.qmd) +#### Concomitant Medications -        [RATET01 -- Event Rate Summary for Recurrent Events](./tables/other/ratet01.qmd) +        [CML01 -- Listing of Previous and Concomitant Medications](./listings/concomitant-medications/cml01.qmd) -        [RBMIT01 -- Tables for RBMI](./tables/other/rbmit01.qmd) +        [CML02A_GL -- Listing of Concomitant Medication Class Level 2, Preferred Name, and Investigator-Specified Terms](./listings/concomitant-medications/cml02a_gl.qmd) -        [RMPT01 -- Duration of Exposure for Risk Management Plan](./tables/other/rmpt01.qmd) +        [CML02B_GL -- Listing of Concomitant Medication Class, Preferred Name, and Investigator-Specified Terms](./listings/concomitant-medications/cml02b_gl.qmd) -        [RMPT03 -- Extent of Exposure by Age Group and Gender for Risk Management Plan](./tables/other/rmpt03.qmd) -        [RMPT04 -- Extent of Exposure by Ethnic Origin for Risk Management Plan](./tables/other/rmpt04.qmd) +#### Disposition -        [RMPT05 -- Extent of Exposure by Race for Risk Management Plan](./tables/other/rmpt05.qmd) +        [DSL01 -- Listing of Patients with Study Drug Withdrawn Due to Adverse Events](./listings/disposition/dsl01.qmd) -        [RMPT06 -- Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan](./tables/other/rmpt06.qmd) +        [DSL02 -- Listing of Patients Who Discontinued Early from Study](./listings/disposition/dsl02.qmd) ------------------------------------------------------------------------- +#### Development Safety Update Report -### **Listings** +        [DSUR4 -- Listing of Patients Who Died During Reporting Period](./listings/development-safety-update-report/dsur4.qmd) -#### Pharmacokinetic -        [ADAL02 -- Listing of Anti-Drug Antibody Data for Treatment Emergent ADA Positive Patients](./listings/pharmacokinetic/adal02.qmd) +#### ECG -        [PKCL01 -- Listing of Drug A Concentration by Treatment Group, Patient and Nominal Time](./listings/pharmacokinetic/pkcl01.qmd) +        [EGL01 -- 'Listing of ECG Data: Safety-Evaluable Patients'](./listings/ECG/egl01.qmd) -        [PKCL02 -- Listing of Drug A Urine Concentration and Volumes](./listings/pharmacokinetic/pkcl02.qmd) -        [PKPL01 -- Listing of Drug A Plasma PK Parameters](./listings/pharmacokinetic/pkpl01.qmd) +#### Exposure -        [PKPL02 -- Listing of Drug A Urine PK Parameters](./listings/pharmacokinetic/pkpl02.qmd) +        [EXL01 -- Listing of Exposure to Study Drug](./listings/exposure/exl01.qmd) -        [PKPL04 -- Listing of Individual Drug A AUCIFO and CMAX Ratios Following Drug A or Drug B](./listings/pharmacokinetic/pkpl04.qmd) +#### Lab Results -#### Other +        [LBL01 -- Listing of Laboratory Test Results](./listings/lab-results/lbl01.qmd) + +        [LBL01_RLS -- Listing of Laboratory Test Results Using Roche Safety Lab Standardization](./listings/lab-results/lbl01_rls.qmd) -        [AEL01 -- Listing of Preferred Terms, Lowest Level Terms, and Investigator-Specified Adverse Event Terms](./listings/other/ael01.qmd) +        [LBL02A -- Listing of Laboratory Abnormalities (constant units)](./listings/lab-results/lbl02a.qmd) -        [AEL01_NOLLT -- Listing of Preferred Terms and Investigator-Specified Adverse Event Terms](./listings/other/ael01_nollt.qmd) +        [LBL02A_RLS -- Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization](./listings/lab-results/lbl02a_rls.qmd) -        [AEL02 -- Listing of Adverse Events](./listings/other/ael02.qmd) +        [LBL02B -- Listing of Laboratory Abnormalities (variable units)](./listings/lab-results/lbl02b.qmd) -        [AEL02_ED -- Listing of Adverse Events (for Early Development Studies)](./listings/other/ael02_ed.qmd) -        [AEL03 -- Listing of Serious Adverse Events](./listings/other/ael03.qmd) +#### Medical History -        [AEL04 -- Listing of Patient Deaths](./listings/other/ael04.qmd) +        [MHL01 -- Listing of Medical History and Concurrent Diseases](./listings/medical-history/mhl01.qmd) -        [CML01 -- Listing of Previous and Concomitant Medications](./listings/other/cml01.qmd) -        [CML02A_GL -- Listing of Concomitant Medication Class Level 2, Preferred Name, and Investigator-Specified Terms](./listings/other/cml02a_gl.qmd) +#### Pharmacokinetic -        [CML02B_GL -- Listing of Concomitant Medication Class, Preferred Name, and Investigator-Specified Terms](./listings/other/cml02b_gl.qmd) +        [PKCL01 -- Listing of Drug A Concentration by Treatment Group, Patient and Nominal Time](./listings/pharmacokinetic/pkcl01.qmd) -        [DSL01 -- Listing of Patients with Study Drug Withdrawn Due to Adverse Events](./listings/other/dsl01.qmd) +        [PKCL02 -- Listing of Drug A Urine Concentration and Volumes](./listings/pharmacokinetic/pkcl02.qmd) -        [DSL02 -- Listing of Patients Who Discontinued Early from Study](./listings/other/dsl02.qmd) +        [PKPL01 -- Listing of Drug A Plasma PK Parameters](./listings/pharmacokinetic/pkpl01.qmd) -        [DSUR4 -- Listing of Patients Who Died During Reporting Period](./listings/other/dsur4.qmd) +        [PKPL02 -- Listing of Drug A Urine PK Parameters](./listings/pharmacokinetic/pkpl02.qmd) -        [EGL01 -- 'Listing of ECG Data: Safety-Evaluable Patients'](./listings/other/egl01.qmd) +        [PKPL04 -- Listing of Individual Drug A AUCIFO and CMAX Ratios Following Drug A or Drug B](./listings/pharmacokinetic/pkpl04.qmd) -        [EXL01 -- Listing of Exposure to Study Drug](./listings/other/exl01.qmd) -        [LBL01 -- Listing of Laboratory Test Results](./listings/other/lbl01.qmd) +#### Vital Signs -        [LBL01_RLS -- Listing of Laboratory Test Results Using Roche Safety Lab Standardization](./listings/other/lbl01_rls.qmd) +        [VSL01 -- 'Listing of Vital Signs: Safety-Evaluable Patients'](./listings/vital-signs/vsl01.qmd) -        [LBL02A -- Listing of Laboratory Abnormalities (constant units)](./listings/other/lbl02a.qmd) -        [LBL02A_RLS -- Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization](./listings/other/lbl02a_rls.qmd) +------------------------------------------------------------------------ -        [LBL02B -- Listing of Laboratory Abnormalities (variable units)](./listings/other/lbl02b.qmd) +### **Graphs** -        [MHL01 -- Listing of Medical History and Concurrent Diseases](./listings/other/mhl01.qmd) +#### Efficacy -        [ONCL01 -- Listing of Individual Efficacy Data](./listings/other/oncl01.qmd) +        [FSTG01 -- Subgroup Analysis of Best Overall Response](./graphs/efficacy/fstg01.qmd) -        [VSL01 -- 'Listing of Vital Signs: Safety-Evaluable Patients'](./listings/other/vsl01.qmd) +        [FSTG02 -- Subgroup Analysis of Survival Duration](./graphs/efficacy/fstg02.qmd) +        [MMRMG01 -- Plots for Mixed-Effect Model Repeated Measures Analysis](./graphs/efficacy/mmrmg01.qmd) ------------------------------------------------------------------------- +        [MMRMG02 -- Forest Plot for Mixed-Effect Model Repeated Measures](./graphs/efficacy/mmrmg02.qmd) -### **Graphs** #### Pharmacokinetic @@ -301,19 +367,11 @@ toc-depth: 4         [CIG01 -- Confidence Interval Plot](./graphs/other/cig01.qmd) -        [FSTG01 -- Subgroup Analysis of Best Overall Response](./graphs/other/fstg01.qmd) - -        [FSTG02 -- Subgroup Analysis of Survival Duration](./graphs/other/fstg02.qmd) -         [IPPG01 -- Individual Patient Plot Over Time](./graphs/other/ippg01.qmd)         [KMG01 -- Kaplan-Meier Plot](./graphs/other/kmg01.qmd)         [LTG01 -- Lattice Plot of Laboratory Tests by Treatment Group Over Time](./graphs/other/ltg01.qmd) -        [MMRMG01 -- Plots for Mixed-Effect Model Repeated Measures Analysis](./graphs/other/mmrmg01.qmd) - -        [MMRMG02 -- Forest Plot for Mixed-Effect Model Repeated Measures](./graphs/other/mmrmg02.qmd) -         [MNG01 -- Mean Plot](./graphs/other/mng01.qmd)