From bc2a46ce6bc905f240c54c97214779179ab56bc5 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Mon, 24 Nov 2025 17:19:25 +0100 Subject: [PATCH 1/7] load variables ccode correctly --- .../dataset_builders/base_dataset_builder.py | 11 +++++++---- 1 file changed, 7 insertions(+), 4 deletions(-) diff --git a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py index 50d6df562..2aa8efbf9 100644 --- a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py +++ b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py @@ -9,7 +9,7 @@ get_corresponding_datasets, tag_source, ) -from typing import List, Iterable +from typing import List, Iterable, Optional from cdisc_rules_engine.utilities import sdtm_utilities from cdisc_rules_engine.utilities.rule_processor import RuleProcessor from cdisc_rules_engine.models.dataset.dataset_interface import DatasetInterface @@ -205,13 +205,16 @@ def get_library_variables_metadata(self) -> DatasetInterface: variables: List[dict] = sdtm_utilities.get_variables_metadata_from_standard( domain=domain, library_metadata=self.library_metadata ) + variables_metadata: dict = self.library_metadata.variables_metadata.get( + domain, {} + ) for variable in variables: variable["ccode"] = "" - if variable.get("codelistSubmissionValues"): + variable_metadata: Optional[dict] = variables_metadata.get(variable["name"]) + if variable_metadata: if "_links" in variable and "codelist" in variable["_links"]: first_codelist = variable["_links"]["codelist"][0] - href = first_codelist["href"] - codelist_code = href.split("/")[-1] + codelist_code = first_codelist["href"].split("/")[-1] variable["ccode"] = codelist_code if "role" not in variable: variable["role"] = "" From ef917abe3f79459f124fb5da1a8d89e1ff361d0b Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Wed, 26 Nov 2025 16:15:47 +0100 Subject: [PATCH 2/7] wip: add regression test --- .../test_Issues/test_CoreIssue1421.py | 86 + tests/resources/CoreIssue1421/Dataset.json | 64579 ++++++++++++++++ tests/resources/CoreIssue1421/Define.xml | 11918 +++ tests/resources/CoreIssue1421/Rule.yml | 66 + 4 files changed, 76649 insertions(+) create mode 100644 tests/QARegressionTests/test_Issues/test_CoreIssue1421.py create mode 100644 tests/resources/CoreIssue1421/Dataset.json create mode 100644 tests/resources/CoreIssue1421/Define.xml create mode 100644 tests/resources/CoreIssue1421/Rule.yml diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py new file mode 100644 index 000000000..ba3c743f0 --- /dev/null +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py @@ -0,0 +1,86 @@ +import os +import subprocess +import openpyxl +import pytest +from conftest import get_python_executable +from QARegressionTests.globals import ( + dataset_details_sheet, + issue_datails_sheet, + rules_report_sheet, + issue_sheet_variable_column, + issue_sheet_coreid_column, +) + + +# @pytest.mark.regression +def test_validate_define_xml_against_lib_metadata(): + command = [ + f"{get_python_executable()}", + "-m", + "core", + "validate", + "-s", + "sdtmig", + "-v", + "3-4", + "-dp", + os.path.join( + "tests", + "resources", + "CoreIssue1421", + "Dataset.json", + ), + "-lr", + os.path.join("tests", "resources", "CoreIssue1421", "Rule.yml"), + "-dxp", + os.path.join("tests", "resources", "CoreIssue1421", "Define.xml"), + ] + subprocess.run(command, check=True) + + # Get the latest created Excel file + files = os.listdir() + excel_files = [ + file + for file in files + if file.startswith("CORE-Report-") and file.endswith(".xlsx") + ] + excel_file_path = sorted(excel_files)[-1] + # Open the Excel file + workbook = openpyxl.load_workbook(excel_file_path) + + # dataset details + # issue summary + + # Go to the "Issue Details" sheet + sheet = workbook[issue_datails_sheet] + + variables_values_column = sheet[issue_sheet_variable_column] + variables_values = [cell.value for cell in variables_values_column[1:] if cell.value is not None] + assert len(variables_values) == 32 + for value in variables_values: + assert len(value.split(",")) == 6 + + variables_names_column = sheet["H"] + variables_names_values = [cell.value for cell in variables_names_column[1:] if cell.value is not None] + assert len(variables_names_values) == 32 + for value in variables_names_values: + assert len(value.split(",")) == 6 + + dataset_column = sheet["D"] + dataset_column_values = [cell.value for cell in dataset_column[1:] if cell.value is not None] + assert sorted(set(dataset_column_values)) == ['ae.xpt', 'dm.xpt', 'ec.xpt', 'ex.xpt'] + + core_id_column = sheet[issue_sheet_coreid_column] + core_id_column_values = [cell.value for cell in core_id_column[1:] if cell.value is not None] + assert set(core_id_column_values) == {"CDISC.SDTMIG.CG0999"} + + # Go to the "Rules Report" sheet + rules_values = [row for row in workbook[rules_report_sheet].iter_rows(values_only=True)][1:] + rules_values = [row for row in rules_values if any(row)] + assert rules_values[0][0] == "CDISC.SDTMIG.CG0999" + assert "SUCCESS" in rules_values[0] + assert rules_values[0][4] == "Issue with codelist definition in the Define-XML document." + + # Delete the excel file + if os.path.exists(excel_file_path): + os.remove(excel_file_path) diff --git a/tests/resources/CoreIssue1421/Dataset.json b/tests/resources/CoreIssue1421/Dataset.json new file mode 100644 index 000000000..d1f8d16d7 --- /dev/null +++ b/tests/resources/CoreIssue1421/Dataset.json @@ -0,0 +1,64579 @@ +{ + "datasets": [ + { + "filename": "dm.xpt", + "label": "Demographics", + "domain": "DM", + "variables": [ + { + "name": "STUDYID", + "label": "Study Identifier", + "type": "char", + "length": 12 + }, + { + "name": "DOMAIN", + "label": "Domain Abbreviation", + "type": "char", + "length": 2 + }, + { + "name": "USUBJID", + "label": "Unique Subject Identifier", + "type": "char", + "length": 8 + }, + { + "name": "SUBJID", + "label": "Subject Identifier for the Study", + "type": "char", + "length": 4 + }, + { + "name": "RFSTDTC", + "label": "Subject Reference Start Date/Time", + "type": "char", + "length": 10 + }, + { + "name": "RFENDTC", + "label": "Subject Reference End Date/Time", + "type": "char", + "length": 10 + }, + { + "name": "RFXSTDTC", + "label": "Date/Time of First Study Treatment", + "type": "char", + "length": 10 + }, + { + "name": "RFXENDTC", + "label": "Date/Time of Last Study Treatment", + "type": "char", + "length": 10 + }, + { + "name": "RFICDTC", + "label": "Date/Time of Informed Consent", + "type": "char", + "length": 10 + }, + { + "name": "RFPENDTC", + "label": "Date/Time of End of Participation", + "type": "char", + "length": 10 + }, + { + "name": "DTHDTC", + "label": "Date/Time of Death", + "type": "char", + "length": 10 + }, + { + "name": "DTHFL", + "label": "Subject Death Flag", + "type": "char", + "length": 1 + }, + { + "name": "SITEID", + "label": "Study Site Identifier", + "type": "char", + "length": 3 + }, + { + "name": "BRTHDTC", + "label": "Date/Time of Birth", + "type": "char", + "length": 10 + }, + { + "name": "AGE", + "label": "Age", + "type": "num", + "length": 8 + }, + { + "name": "AGEU", + "label": "Age Units", + "type": "char", + "length": 5 + }, + { + "name": "SEX", + "label": "Sex", + "type": "char", + "length": 1 + }, + { + "name": "RACE", + "label": "Race", + "type": "char", + "length": 41 + }, + { + "name": "ETHNIC", + "label": "Ethnicity", + "type": "char", + "length": 22 + }, + { + "name": "ARMCD", + "label": "Planned Arm Code", + "type": "char", + "length": 8 + }, + { + "name": "ARM", + "label": "Description of Planned Arm", + "type": "char", + "length": 28 + }, + { + "name": "ACTARMCD", + "label": "Actual Arm Code", + "type": "char", + "length": 8 + }, + { + "name": "ACTARM", + "label": "Description of Actual Arm", + "type": "char", + "length": 28 + }, + { + "name": "ARMNRS", + "label": "Reason Arm and/or Actual Arm is Null", + "type": "char", + "length": 14 + }, + { + "name": "ACTARMUD", + "label": "Description of Unplanned Actual Arm", + "type": "char", + "length": 200 + }, + { + "name": "COUNTRY", + "label": "Country", + "type": "char", + "length": 3 + } + ], + "records": { + "STUDYID": [ + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01", + "CDISCPILOT01" + ], + "DOMAIN": [ + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM", + "DM" + ], + "USUBJID": [ + "CDISC001", + "CDISC002", + "CDISC003", + "CDISC004", + "CDISC005", + "CDISC006", + "CDISC007", + "CDISC008", + "CDISC009", + "CDISC010", + "CDISC011", + "CDISC012", + "CDISC013", + "CDISC014", + "CDISC015", + "CDISC016", + "CDISC017", + "CDISC018" + ], + "SUBJID": [ + "1115", + "1211", + "1302", + "1345", + "1383", + "1429", + "1444", + "1445", + "1087", + "1236", + "1336", + "1378", + "1083", + "1012", + "1022", + "1143", + "1250", + "1427" + ], + "RFSTDTC": [ + "2012-11-30", + "2012-11-15", + "2013-08-29", + "2013-10-08", + "2013-02-04", + "2013-03-19", + "2013-01-05", + "2014-05-11", + "2012-10-22", + "2013-09-21", + "2012-12-07", + "2013-09-03", + "2013-07-22", + "2013-04-03", + "", + "2013-04-03", + "2013-09-21", + "2012-12-17" + ], + "RFENDTC": [ + "2013-01-23", + "2013-01-14", + "2013-11-05", + "2014-03-18", + "2013-08-06", + "2013-04-30", + "2013-02-13", + "2014-11-01", + "2013-04-28", + "2013-09-26", + "2013-06-05", + "2014-01-28", + "2013-08-03", + "2013-05-02", + "", + "2013-06-01", + "2014-02-08", + "2013-02-18" + ], + "RFXSTDTC": [ + "2012-11-30", + "2012-11-15", + "2013-08-29", + "2013-10-08", + "2013-02-04", + "2013-03-19", + "2013-01-05", + "2014-05-11", + "2012-10-22", + "2013-09-21", + "2012-12-07", + "2013-09-03", + "2013-07-22", + "2013-04-03", + "", + "2013-04-03", + "2013-09-21", + "2012-12-17" + ], + "RFXENDTC": [ + "2013-01-23", + "2013-01-12", + "2013-11-05", + "2014-03-18", + "2013-08-06", + "2013-04-30", + "2013-02-12", + "2014-11-01", + "2013-04-28", + "2013-09-21", + "2013-06-05", + "2014-01-28", + "2013-08-01", + "2013-04-29", + "", + "2013-05-30", + "2014-01-31", + "2013-02-11" + ], + "RFICDTC": [ + "2012-11-23", + "2012-10-30", + "2013-08-20", + "2013-10-01", + "2013-01-22", + "2013-02-25", + "2012-12-31", + "2014-05-01", + "2012-10-06", + "2013-09-08", + "2012-11-21", + "2013-08-24", + "2013-07-09", + "2013-03-20", + "2014-03-17", + "2013-03-30", + "2013-08-21", + "2012-12-13" + ], + "RFPENDTC": [ + "2013-05-20", + "2013-01-14", + "2014-02-13", + "2014-03-18", + "2013-08-06", + "2013-04-30", + "2013-06-20", + "2014-11-01", + "2013-04-28", + "2013-09-26", + "2013-07-05", + "2014-01-28", + "2013-08-03", + "2013-09-18", + "2014-03-17", + "2013-09-22", + "2014-03-08", + "2013-06-03" + ], + "DTHDTC": [ + "", + "2013-01-14", + "", + "", + "", + "", + "", + "2014-11-01", + "", + "", + "", + "", + "2013-08-03", + "", + "", + "", + "", + "" + ], + "DTHFL": [ + "", + "Y", + "", + "", + "", + "", + "", + "Y", + "", + "", + "", + "", + "Y", + "", + "", + "", + "", + "" + ], + "SITEID": [ + "701", + "701", + "701", + "701", + "701", + "701", + "701", + "704", + "708", + "708", + "708", + "708", + "710", + "711", + "711", + "711", + "718", + "718" + ], + "BRTHDTC": [ + "1928", + "1936", + "1951", + "1950", + "1941", + "1929", + "1949", + "1939", + "1938", + "1927", + "1939", + "1946", + "1924", + "1945", + "1928", + "1936", + "1931", + "1938" + ], + "AGE": [ + 84, + 76, + 61, + 63, + 72, + 84, + 63, + 75, + 74, + 86, + 73, + 67, + 89, + 67, + 86, + 76, + 82, + 74 + ], + "AGEU": [ + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS", + "YEARS" + ], + "SEX": [ + "M", + "F", + "M", + "F", + "F", + "F", + "M", + "M", + "F", + "F", + "M", + "M", + "F", + "F", + "F", + "F", + "F", + "F" + ], + "RACE": [ + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "MULTIPLE", + "WHITE", + "WHITE", + "WHITE", + "BLACK OR AFRICAN AMERICAN", + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "WHITE", + "BLACK OR AFRICAN AMERICAN" + ], + "ETHNIC": [ + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO", + "HISPANIC OR LATINO", + "NOT HISPANIC OR LATINO" + ], + "ARMCD": [ + "ZAN_LOW", + "ZAN_LOW", + "ZAN_HIGH", + "PLACEBO", + "ZAN_HIGH", + "ZAN_LOW", + "ZAN_HIGH", + "PLACEBO", + "PLACEBO", + "ZAN_HIGH", + "ZAN_HIGH", + "PLACEBO", + "PLACEBO", + "ZAN_HIGH", + "", + "ZAN_LOW", + "ZAN_LOW", + "ZAN_HIGH" + ], + "ARM": [ + "Zanomaline Low Dose (54 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Zanomaline High Dose (81 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Placebo", + "Zanomaline High Dose (81 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Placebo", + "Zanomaline High Dose (81 mg)", + "", + "Zanomaline Low Dose (54 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)" + ], + "ACTARMCD": [ + "ZAN_LOW", + "ZAN_LOW", + "ZAN_HIGH", + "PLACEBO", + "ZAN_HIGH", + "ZAN_LOW", + "ZAN_HIGH", + "PLACEBO", + "PLACEBO", + "ZAN_HIGH", + "ZAN_HIGH", + "PLACEBO", + "PLACEBO", + "ZAN_HIGH", + "", + "ZAN_LOW", + "ZAN_LOW", + "ZAN_HIGH" + ], + "ACTARM": [ + "Zanomaline Low Dose (54 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Zanomaline High Dose (81 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Placebo", + "Zanomaline High Dose (81 mg)", + "Zanomaline High Dose (81 mg)", + "Placebo", + "Placebo", + "Zanomaline High Dose (81 mg)", + "", + "Zanomaline Low Dose (54 mg)", + "Zanomaline Low Dose (54 mg)", + "Zanomaline High Dose (81 mg)" + ], + "ARMNRS": [ + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "SCREEN FAILURE", + "", + "", + "" + ], + "ACTARMUD": [ + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "", + "" + ], + "COUNTRY": [ + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA", + "USA" + ] + } + }, + { + "filename": "ae.xpt", + "label": "Adverse Events", + "domain": "AE", + "variables": [ + { + "name": "STUDYID", + "label": "Study Identifier", + "type": "char", + "length": 12 + }, + { + "name": "DOMAIN", + "label": "Domain Abbreviation", + "type": "char", + "length": 2 + }, + { + "name": "USUBJID", + "label": "Unique Subject Identifier", + "type": "char", + "length": 8 + }, + { + "name": "AESEQ", + "label": "Sequence Number", + "type": "num", + "length": 8 + }, + { + "name": "AELNKID", + "label": "Link ID", + "type": "char", + "length": 50 + }, + { + "name": "AETERM", + "label": "Reported Term for the Adverse Event", + "type": "char", + "length": 200 + }, + { + "name": "AELLT", + "label": "Lowest Level Term", + "type": "char", + "length": 1 + }, + { + "name": "AELLTCD", + "label": "Lowest Level Term Code", + "type": "char", + "length": 1 + }, + { + "name": "AEDECOD", + "label": "Dictionary-Derived Term", + "type": "char", + "length": 1 + }, + { + "name": "AEPTCD", + "label": "Preferred Term Code", + "type": "char", + "length": 1 + }, + { + "name": "AEHLT", + "label": "High Level Term", + "type": "char", + "length": 1 + }, + { + "name": "AEHLTCD", + "label": "High Level Term Code", + "type": "char", + "length": 1 + }, + { + "name": "AEHLGT", + "label": "High Level Group Term", + "type": "char", + "length": 1 + }, + { + "name": "AEHLGTCD", + "label": "High Level Group Term Code", + "type": "char", + "length": 1 + }, + { + "name": "AEBODSYS", + "label": "Body System or Organ Class", + "type": "char", + "length": 1 + }, + { + "name": "AEBDSYCD", + "label": "Body System or Organ Class Code", + "type": "char", + "length": 1 + }, + { + "name": "AESOC", + "label": "Primary System Organ Class", + "type": "char", + "length": 1 + }, + { + "name": "AESOCCD", + "label": "Primary System Organ Class Code", + "type": "char", + "length": 1 + }, + { + "name": "AESEV", + "label": "Severity/Intensity", + "type": "char", + "length": 8 + }, + { + "name": "AESER", + "label": "Serious Event", + "type": "char", + "length": 1 + }, + { + "name": "AEACN", + "label": "Action Taken with Study Treatment", + "type": "char", + "length": 16 + }, + { + "name": "AEREL", + "label": "Causality", + "type": "char", + "length": 16 + }, + { + "name": "AEOUT", + "label": "Outcome of Adverse Event", + "type": "char", + "length": 32 + }, + { + "name": "AESCAN", + "label": "Involves Cancer", + "type": "char", + "length": 1 + }, + { + "name": "AESCONG", + "label": "Congenital Anomaly or Birth Defect", + "type": "char", + "length": 1 + }, + { + "name": "AESDISAB", + "label": "Persist or Signif Disability/Incapacity", + "type": "char", + "length": 1 + }, + { + "name": "AESDTH", + "label": "Results in Death", + "type": "char", + "length": 1 + }, + { + "name": "AESHOSP", + "label": "Requires or Prolongs Hospitalization", + "type": "char", + "length": 1 + }, + { + "name": "AESLIFE", + "label": "Is Life Threatening", + "type": "char", + "length": 1 + }, + { + "name": "AESOD", + "label": "Occurred with Overdose", + "type": 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List A Word 9 + + + + + + AVLT-REY - List A Word 10 + + + + + + AVLT-REY - List A Word 11 + + + + + + AVLT-REY - List A Word 12 + + + + + + AVLT-REY - List A Word 13 + + + + + + AVLT-REY - List A Word 14 + + + + + + AVLT-REY - List A Word 15 + + + + + + AVLT-REY - List A Total + + + + + + AVLT-REY - List A Intrusions + + + + + + AVLT-REY - List B Word 1 + + + + + + AVLT-REY - List B Word 2 + + + + + + AVLT-REY - List B Word 3 + + + + + + AVLT-REY - List B Word 4 + + + + + + AVLT-REY - List B Word 5 + + + + + + AVLT-REY - List B Word 6 + + + + + + AVLT-REY - List B Word 7 + + + + + + AVLT-REY - List B Word 8 + + + + + + AVLT-REY - List B Word 9 + + + + + + AVLT-REY - List B Word 10 + + + + + + AVLT-REY - List B Word 11 + + + + + + AVLT-REY - List B Word 12 + + + + + + AVLT-REY - List B Word 13 + + + + + + AVLT-REY - List B Word 14 + + + + + + AVLT-REY - List B Word 15 + + + + + + AVLT-REY - List B Total + + + + + + AVLT-REY - List B Intrusions + + + + + + + + + Recalled + + + + + Not Recalled + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Primary Cause of Death + + + + + + + + + + + + + + + + + + Device Type + + + + + + Serial Number + + + + + + + + + Adverse Events + + + + + + + + + Concomitant/Prior Medications + + + + + + + + + Death Details + + + + + + + + + Device Identifiers + + + + + + + + + Demographics + + + + + + + + + Disposition + + + + + + + + + Exposure as Collected + + + + + + + + + Exposure + + + + + + + + + Findings About Events or Interventions + + + + + + + + + Functional Tests + + + + + + + + + Inclusion/Exclusion Criteria Not Met + + + + + + + + + Laboratory Test Results + + + + + + + + + Medical History + + + + + + + + + Nervous Sysytem Findings + + + + + + + + + Ophthalmic Examinations + + + + + + + + + Questionnaires + + + + + + + + + Disease Response and Clin Classification + + + + + + + + + Subject Elements + + + + + + + + + Subject Visits + + + + + + + + + Trial Arms + + + + + + + + + Trial Elements + + + + + + + + + Trial Inclusion + + + + + + + + + Trial Summary + + + + + + + + + Trial Visits + + + + + + + + + Vital Signs + + + + + + + + + Disposition Event + + + + + + Protocol Milestone + + + + + + + + + Study Treatment + + + + + Study Participation + + + + + + + + + + + + + + Ongoing + + + + + + + + + Screening + + + + + + Treatment + + + + + + + + + Zanomaline 81 mg + + + + + Zanomaline 54 mg + + + + + Placebo + + + + + Screening + + + + + Zanomaline 54 mg Titration + + + + + + + Hispanic or Latino + + + + + + Not Hispanic or Latino + + + + + + + + + Placebo + + + + + Zanomaline + + + + + + + Injection Site Reaction + + + + + + + Erythema + + + + + Pain + + + + + Induration + + + + + Pruritus + + + + + Edema + + + + + + + No + + + + + + Yes + + + + + + + + + Mild + + + + + + Moderate + + + + + + Severe + + + + + + + + + + + + + Occurrence Indicator + + + + + Severity/Intensity + + + + + + + Daily + + + + + + As Needed + + + + + + Twice Daily + + + + + + Every Four Hours + + + + + + Four Times Daily + + + + + + Every Six Hours + + + + + + + + + Daily + + + + + + + + + Injectable Dosage Form + + + + + + + + + Rey Auditory Verbal Learning Functional Test + + + + + + + + + + + + + + + + Absent. + + + + + These feeling states indicated only on questioning. + + + + + These feeling states spontaneously reported verbally. + + + + + Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep. + + + + + Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication. + + + + + + + + + + + + + + Absent. + + + + + Self reproach, feels he/she has let people down. + + + + + Ideas of guilt or rumination over past errors or sinful deeds. + + + + + Present illness is a punishment. Delusions of guilt. + + + + + Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations. + + + + + + + + + + + + + + Absent. + + + + + Feels life is not worth living. + + + + + Wishes he/she were dead or any thoughts of possible death to self. + + + + + Ideas or gestures of suicide. + + + + + Attempts at suicide (any serious attempt rate 4). + + + + + + + + + + + + No difficulty falling asleep. + + + + + Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour + + + + + Complains of nightly difficulty falling asleep. + + + + + + + + + + + + No difficulty. + + + + + Patient complains of being restless and disturbed during the night. + + + + + Waking during the night - any getting out of bed rates 2 (except for purposes of voiding). + + + + + + + + + + + + No difficulty. + + + + + Waking in early hours of the morning but goes back to sleep. + + + + + Unable to fall asleep again if he/she gets out of bed. + + + + + + + + + + + + + + No difficulty. + + + + + Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies. + + + + + Loss of interest in activity, hobbies or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities). + + + + + Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores. + + + + + Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted. + + + + + + + + + + + + + + Normal speech and thought. + + + + + Slight retardation during the interview. + + + + + Obvious retardation during the interview. + + + + + Interview difficult. + + + + + Complete stupor. + + + + + + + + + + + + + + None. + + + + + Fidgetiness. + + + + + Playing with hands, hair, etc. + + + + + Moving about, cannot sit still. + + + + + Hand wringing, nail biting, hair-pulling, biting of lips. + + + + + + + + + + + + + + No difficulty. + + + + + Subjective tension and irritability. + + + + + Worrying about minor matters. + + + + + Apprehensive attitude apparent in face or speech. + + + + + Fears expressed without questioning. + + + + + + + + + + + + + + Absent. + + + + + Mild. + + + + + Moderate. + + + + + Severe. + + + + + Incapacitating. + + + + + + + + + + + + None. + + + + + Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen. + + + + + Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms. + + + + + + + + + + + + None. + + + + + Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability. + + + + + Any clear-cut symptom rates 2. + + + + + + + + + + + + Absent. + + + + + Mild. + + + + + Severe. + + + + + + + + + + + + + + Not present. + + + + + Self-absorption (bodily). + + + + + Preoccupation with health. + + + + + Frequent complaints, requests for help, etc. + + + + + Hypochondriacal delusions. + + + + + + + + + + + + + No weight loss. + + + + + Probable weight loss associated with present illness. + + + + + Definite (according to patient) weight loss. + + + + + Not assessed. + + + + + + + + + + + + + Less than 1 lb weight loss in week. + + + + + Greater than 1 lb weight loss within week. + + + + + Greater than 2 lb weight loss in week. + + + + + Not assessed. + + + + + + + + + + + + Acknowledges being depressed and ill. + + + + + Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc. + + + + + Denies being ill at all. + + + + + + + HAMD1-Depressed Mood + + + + + + HAMD1-Feelings of Guilt + + + + + + HAMD1-Suicide + + + + + + HAMD1-Insomnia Early - Early Night + + + + + + HAMD1-Insomnia Middle - Middle Night + + + + + + HAMD1-Insomnia Early Hours - Morning + + + + + + HAMD1-Work and Activities + + + + + + HAMD1-Retardation + + + + + + HAMD1-Agitation + + + + + + HAMD1-Anxiety Psychic + + + + + + HAMD1-Anxiety Somatic + + + + + + HAMD1-Somatic Symptoms GI + + + + + + HAMD1-General Somatic Symptoms + + + + + + HAMD1-Genital Symptoms + + + + + + HAMD1-Hypochondriasis + + + + + + HAMD1-Loss of WT According to Patient + + + + + + HAMD1-Loss of WT According to WK Meas + + + + + + HAMD1-Insight + + + + + + HAMD1-Total Score + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Exclusion + + + + + + Inclusion + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Males and postmenopausal females at least 50 years of age. + + + + + Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines. + + + + + MMSE score of 10 to 23. + + + + + Modified Hachinski Ischemic Scale score of <= 4. + + + + + CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. (See Protocol for incompatible findings.) + + + + + Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver. + + + + + Geographic proximity to investigator's site that allows adequate follow-up. + + + + + Caregiver will monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. + + + + + Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of Zanomaline. + + + + + Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study. + + + + + Serious illness which required hospitalization within 3 months of screening. + + + + + Diagnosis of serious neurological conditions + + + + + Episode of depression meeting DSM-IV criteria within 3 months of screening. + + + + + A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence. + + + + + A history of syncope within the last 5 years. + + + + + Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia <50 beats per minute c) Sinus pauses >2 seconds (See Protocol for Remainder) + + + + + A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder) + + + + + A history within the last 5 years of a serious gastrointestinal disorder, including +a) Chronic peptic/duodenal/gastric/esophageal ulcer that are untreated or refractory to treatment(See Protocol) + + + + + A history within the last 5 years of a serious endocrine disorder, including +a) Uncontrolled Insulin Dependent Diabetes Mellitus (IDDM) (See Protocol for other excluded disorders) + + + + + A history within the last 5 years of a serious respiratory disorder, including a) Asthma with bronchospasm refractory to treatment b) Decompensated chronic obstructive pulmonary disease. + + + + + A history within the last 5 years of a serious genitourinary disorder, including a) Renal failure b) Uncontrolled urinary retention + + + + + A history within the last 5 years of a serious rheumatologic disorder, including a) Lupus b) Temporal arteritis c) Severe rheumatoid arthritis + + + + + A known history of human immunodeficiency virus (HIV) within the last 5 years. + + + + + A history within the last 5 years of a serious infectious disease including a) Neurosyphilis b) Meningitis c) Encephalitis + + + + + A history within the last 5 years of a primary or recurrent malignant disease (See Exceptions in Protocol). + + + + + Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy). + + + + + Laboratory test values exceeding the Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, (See Protocol for Additional Analytes) + + + + + Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests. + + + + + Positive syphilis screening with confirmatory testing. + + + + + Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only). + + + + + Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active + + + + + Diagnosis of serious neurological conditions (Amend 1) + + + + + Treatment with medications within 1 month prior to enrollment a) Anticonvulsants b) Alpha receptor blockers c) Calcium channel blockers that are CNS active (Amend 1) + + + + + + + Parallel + + + + + + + + + Drug + + + + + + + + + Left + + + + + + Right + + + + + + + + + Chemistry + + + + + Hematology + + + + + Urinalysis + + + + + Other + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Albumin Measurement + + + + + + Alkaline Phosphatase Measurement + + + + + + Alanine Aminotransferase Measurement + + + + + + Anisocyte Measurement + + + + + + Aspartate Aminotransferase Measurement + + + + + + Total Basophil Count + + + + + + Total Bilirubin Measurement + + + + + + Calcium Measurement + + + + + + Cholesterol Measurement + + + + + + Creatine Kinase Measurement + + + + + + Chloride Measurement + + + + + + Color Assessment + + + + + + Creatinine Measurement + + + + + + Eosinophil Count + + + + + + Gamma Glutamyl Transpeptidase Measurement + + + + + + Glucose Measurement + + + + + + Hematocrit Measurement + + + + + + Hemoglobin Measurement + + + + + + Potassium Measurement + + + + + + Ketone Measurement + + + + + + Lymphocyte Count + + + + + + Macrocyte Count + + + + + + Erythrocyte Mean Corpuscular Hemoglobin + + + + + + Erythrocyte Mean Corpuscular Hemoglobin Concentration + + + + + + Erythrocyte Mean Corpuscular Volume + + + + + + Monocyte Count + + + + + + pH + + + + + + Phosphate Measurement + + + + + + Platelet Count + + + + + + Poikilocyte Measurement + + + + + + Total Protein Measurement + + + + + + Erythrocyte Count + + + + + + Sodium Measurement + + + + + + Specific Gravity + + + + + + Thyrotropin Measurement + + + + + + Urate Measurement + + + + + + Urea Nitrogen Measurement + + + + + + Urobilinogen Measurement + + + + + + Vitamin B12 Measurement + + + + + + Leukocyte Count + + + + + + + + + + + + + + + Conjunctiva + + + + + + Eye + + + + + + Anterior Chamber of the Eye + + + + + + Iris + + + + + + Cornea + + + + + + + + + Ear + + + + + + Oral Cavity + + + + + + + + + Symptom Onset + + + + + + + + + Alzheimer's Disease + + + + + + + Adverse Event + + + + + + Completed + + + + + + Death + + + + + + Lack of Efficacy + + + + + + Lost to Follow-Up + + + + + + Other + + + + + + Physician Decision + + + + + + Pregnancy + + + + + + Protocol Deviation + + + + + + Screen Failure + + + + + + Study Terminated By Sponsor + + + + + + Withdrawal By Parent/Guardian + + + + + + Withdrawal By Subject + + + + + + + + + Not Done + + + + + + + + + Abnormal + + + + + + Normal + + + + + + + + + Abnormal + + + + + + High + + + + + + Low + + + + + + Normal + + + + + + + + + + + + + Interpretation + + + + + + + + No + + + + + + Yes + + + + + + + + + Yes + + + + + + + + + Right Eye + + + + + + Left Eye + + + + + + + + + Slit-lamp Examination + + + + + + + + + + + + + + + + Abnormality Detail + + + + + Interpretation + + + + + + + + + Fatal + + + + + + Not Recovered/Not Resolved + + + + + + Recovered/Resolved + + + + + + Recovered/Resolved With Sequelae + + + + + + Recovering/Resolving + + + + + + Unknown + + + + + + + + + PHQ01-Little Interest/Pleasure in Things + + + + + + PHQ01-Feeling Down Depressed or Hopeless + + + + + + PHQ01-Trouble Falling or Staying Asleep + + + + + + PHQ01-Feeling Tired or Little Energy + + + + + + PHQ01-Poor Appetite or Overeating + + + + + + PHQ01-Feeling Bad About Yourself + + + + + + PHQ01-Trouble Concentrating on Things + + + + + + PHQ01-Moving Slowly or Fidgety/Restless + + + + + + PHQ01-Thoughts You Be Better Off Dead + + + + + + PHQ01-Difficult to Work/Take Care Things + + + + + + PHQ01-Total Score + + + + + + + + + + + + + + + + + + + + + Not at all + + + + + Several days + + + + + More than half the days + + + + + Nearly every day + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Standing + + + + + + Supine + + + + + + + + + Informed Consent + + + + + + + + + Patient Health Questionnaire - 9 Item + + + + + + + + + Satisfaction With Life Scale Questionnaire + + + + + + + + + American Indian Or Alaska Native + + + + + + Asian + + + + + + Black Or African American + + + + + + Native Hawaiian Or Other Pacific Islander + + + + + + White + + + + + + + + + Multiple + + + + + + + Adverse Events + + + + + + Disposition + + + + + + Death Details + + + + + + Findings About Events or Interventions + + + + + + + + + Many + + + + + + One + + + + + + + + + Oral + + + + + + Topical + + + + + + Intravenous + + + + + + Nasal + + + + + + Inhalation Route of Administration + + + + + + Transdermal + + + + + + + + + Subcutaneous Route of Administration + + + + + + + + + Hamilton Depression Rating Scale 17 Item Clinical Classification + + + + + + + + + Female + + + + + + Male + + + + + + + + + + + + + + + + + Interventional + + + + + + + + + SWLS01-Have Gotten Important Things + + + + + + SWLS01-I Am Satisfied with My Life + + + + + + SWLS01-Live Life Over Change Nothing + + + + + + SWLS01-My Life Conditions are Excellent + + + + + + SWLS01-My Life is Close to Ideal + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Strongly disagree + + + + + Disagree + + + + + Slightly disagree + + + + + Neither agree nor disagree + + + + + Slightly agree + + + + + Agree + + + + + Strongly agree + + + + + + + Double Blind + + + + + + + + + Placebo + + + + + + + + + Treatment + + + + + + + + + Phase II Trial + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Actual Subject Number + + + + + + Adaptive Study Design Indicator + + + + + + Test Product Added to Existing Treatment + + + + + + Planned Maximum Age of Subjects + + + + + + Planned Minimum Age of Subjects + + + + + + Data Cutoff Date Description + + + + + + Data Cutoff Date + + + + + + Dose + + + + + + Pharmaceutical Dosage Form + + + + + + Dose Frequency + + + + + + Dosage Form Unit + + + + + + Planned Country of Investigational Site + + + + + + Healthy Subject Indicator + + + + + + Trial Indication + + + + + + Intervention Model + + + + + + Intervention Type + + + + + + Trial Length + + + + + + Planned Number of Arms + + + + + + Trial Primary Objective + + + + + + Trial Secondary Objective + + + + + + Primary Outcome Measure + + + + + + Secondary Outcome Measure + + + + + + Pharmacological Class of Investigational Therapy + + + + + + Planned Subject Number + + + + + + Randomization + + + + + + Randomization Quotient + + + + + + Clinical Trial Registry Identifier + + + + + + Route of Administration + + + + + + Study Data Tabulation Model Implementation Guide Version + + + + + + Study Data Tabulation Model Version + + + + + + Clinical Study End Date + + + + + + Sex of Study Group + + + + + + Clinical Study Sponsor + + + + + + Study Start Date + + + + + + Study Stop Rule + + + + + + Study Type + + + + + + Trial Blinding Schema + + + + + + Control Type + + + + + + Diagnosis Group + + + + + + Clinical Study by Intent + + + + + + Trial Title + + + + + + Trial Phase + + + + + + Protocol Agent + + + + + + Trial Type + + + + + + + + + Efficacy + + + + + + Pharmacokinetic + + + + + + Safety + + + + + + + + + Milligram + + + + + + Nanogram + + + + + + Tablet + + + + + + + + + Milliliter + + + + + + + + + Gram per Liter + + + + + + + + + Milligram + + + + + + + + + Million per Microliter + + + + + + + + + Billion per Liter + + + + + + + + + Percentage + + + + + + + + + Unit per Liter + + + + + + + + + Femtoliter + + + + + + + + + Femtomole + + + + + + + + + Femtomole + + + + + + + + + Gram per Deciliter + + + + + + + + + Milliequivalent Per Liter + + + + + + + + + Microinternational Unit per Milliliter + + + + + + + + + Microunit per Milliliter + + + + + + + + + Milligram per Deciliter + + + + + + + + + Millimole per Liter + + + + + + + + + Nanogram per Liter + + + + + + + + + Picogram + + + + + + + + + Picomole per Liter + + + + + + + + + Micromole per Liter + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Diastolic Blood Pressure + + + + + + Pulse Rate + + + + + + Height + + + + + + Systolic Blood Pressure + + + + + + Temperature + + + + + + Weight + + + + + + + + + Millimeter of Mercury + + + + + + + + + Millimeter of Mercury + + + + + + + + + Inch + + + + + + + + + Centimeter + + + + + + + + + Beats per Minute + + + + + + + + + Beats per Minute + + + + + + + + + Degree Fahrenheit + + + + + + + + + Degree Celsius + + + + + + + + + Pound + + + + + + + + + Kilogram + + + + + + + + + + + + + + + + + + + + + + + + + + If AEENRTPT is populated, AEENTPT is DM.RFPENDTC for the subject. + + + + + If CMENRTPT is populated, CMENTPT is DM.RFPENDTC for the subject. + + + + + Study day relative to RFSTDTC. Date - RFSTDTC + 1 if on or after RFSTDTC. Date - RFSTDTC if date precedes RFSTDTC. + + + + + Starts at "1" for first device identifier and increments by one for each DIPARM + + + + + If DTHDTC is populated then DTHFL='Y' + + + + + EPOCH from SE where date >= SESTDTC and date < SEENDTC + + + + + EXDOSE = ECDOSE * ECPSTRG expressed in mg. + + + + + If FTSTRESC is numeric then FTSTRESN=FTSTRESC in numeric format, else null. + + + + + If IECAT=INCLUSION then IEORRES=N, else if IECAT=EXCLUSION then IEORRES=Y + + + + + LBSTRESC is equal to LBORRES or the value in standard units if a conversion is necessary. + + + + + Set to "Y" for last record with non-null original result on or before the first dose date (RFXSTDTC). Null otherwise. + + + + + If QSORRES="Not at all" then 0 +If QSORRES="Several days" then 1 +If QSORRES="More than half the days" then 2 +If QSORRES="Nearly every day" then 3 + + + + + QSSTRESC=QSORRES + + + + + If QSORRES="Strongly disagree" then 1 +If QSORRES="Disagree" then 2 +If QSORRES="Slightly disagree" then 3 +If QSORRES="Neither agree nor disagree" then 4 +If QSORRES="Slightly agree" then 5 +If QSORRES="Agree" then 6 +If QSORRES="Strongly agree" then 7 + + + + + If QSSTRESC is numeric then QSSTRESN=QSSTRESC in numeric format, else null. + + + + + The Date of Study Completion or Early Termination. Null for screen failures. + + + + + The latest date of assessment for the subject as determined by the End of Study Form, any scheduled assessments, Adverse Events, or Concomitant Medications. + + + + + The first date/time of study drug. Null for screen failures. + + + + + The last date/time of study drug administration. Null for subjects with no treatment data. + + + + + The first date/time of study drug administration. Null for subjects with no treatment data. + + + + + RSSTRESC is the corresponding numeric value of RSORRES according the values shown on the HAMD-17 CRF page. + + + + + SEENDTC is set to the start of the next Element, or RFPENDTC for the last Element. + + + + + Unique sequence number within a subject, restarting at 1 for every subject, applied to sorted data. + + + + + SESTDTC if set to the --DTC for that subject which exists in the data for the defined start of the Element, such as DSSTDTC when DSDECOD=INFORMED CONSENT OBTAINED for Screening Elements or min(EXSTDTC) for Dosing Elements. + + + + + If --STRESC represents a numeric value then --STRESN is the numeric version of --STRESC, else null. "--" represents the domain code. + + + + + For each scheduled visit, SVENDTC = the last (max) date associated with a subject for that visit. For unplanned visits, SVENDTC is the date of the visit. + + + + + For each scheduled visit, SVSTDTC = the first (min) date associated with a subject for that visit. For unplanned visits, SVSTDTC is the date of the visit. + + + + + Unique sequence number within each TSPARM, restarting at 1 for per TSPARM, applied to sorted data. + + + + + Data collected in conventional units (i.e. F, lbs, inches) is converted using standard conversion factors to standard units (C, kg, cm). + + + + + + + + + + + Even though the variable is 'Assigned' an annotation has been added to page 23 to clarify the assignment. + + + + + Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. + + + + + Coding variables are not populated due to the proprietary coding dictionary, but the variables are included as they are Expected or Required. Note CDISC Conformance Rule CG0014 would fire for this variable due to the decision not to populate coding variables. + + + + + Subject CDISC003 had an AE of Epistaxis on 2013-09-30 with AESER set to 'Y' without any of the individual serious qualifiers set to 'Y' also. The site was queried several times but the data were not updated. Note Conformance Rule CG0041 would fire for this subject. + + + + + If the CM is not taken for a 'Primary Study Condition' then CMINDC would be 'Prophylaxis or Non-therapeutic use' + + + + + Since no collected data was subjective then QEVAL was not populated. It is an 'Expected' variable and so is included. + + + + + Since no subjects had more than 3 Races, RACE4 was not used. + + + + + Since no subjects had more than 3 Races, RACE5 was not used. + + + + + Variable is Assigned but there are annotations to help understand the data and so references to the proper pages are included + + + + + DataType is 'partialDatetime' instead of 'datetime' since datetime values are planned to be collected without seconds for this study. + + + + + All values are null as the findings are not visit based. The variable is Expected and so is included. + + + + + The FA domain contains Findings About Injection Site Reaction Adverse Events + + + + + IEDY is needed if IEDTC is included. Note RFSTDTC is not populated for not randomized subjects then IEDY could not be populated in those cases. + + + + + Please see Appendix 1 of the cSDRG for complete versions of IETESTCD and IETEST. + + + + + Standard's Conformance Notes: +1) The SDTM v1.7/SDTMIG v3.3 datasets were evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC SDTM v1.7/SDTMIG v3.3 conformance rules were recently published, but not available by any validation tools to validate. +2) The Define-XML document was evaluated manually and programmatically by the CDISC SDS MSG Team. At the completion of the SDTM-MSG v2.0, the CDISC +Define-XML v2.1 conformance rules were not published, nor available by any validation tools to validate. Please ensure that any official regulatory submission of an Define-XML v2.1 document and accompanying data is done in accordance to the respective regulatory health authorities requirements/guidance. + + + + + Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such was not submitted. + + + + + Per protocol, electroencephalograms are only performed after such an event were to occur. No subjects within the trial had an occurrence of an electroencephalogram event. Therefore, no data exists for the NV dataset and as such SUPPNV was not submitted. + + + + + No subjects within the trial had an ophthalmic examination of clinical significance to report. Therefore, no data exists for the SUPPOE dataset and as such was not submitted. + + + + + QSPH contains the PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9) questionnaire data. + + + + + QSSL contains the SATISFACTION WITH LIFE SURVEY (SWLS) questionnaire data. + + + + + Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3 + + + + + Study Data Tabulation Model Implementation Guide for Medical Devices Version 1.0 + + + + + This was the latest release of CDISC CT available when this sample submission was completed. + + + + + This was the CDISC CT Package associated to the CDISC Define-XML Specification Version 2.1 when this sample submission was completed. + + + + + All vital signs were performed as expected, so VSSTAT was never populated. The variable is included as it was possible to populate it in this study. + + + + + + + + + + Annotated CRF + + + + Reviewers Guide + + + + + + + + + + diff --git a/tests/resources/CoreIssue1421/Rule.yml b/tests/resources/CoreIssue1421/Rule.yml new file mode 100644 index 000000000..bb1157f65 --- /dev/null +++ b/tests/resources/CoreIssue1421/Rule.yml @@ -0,0 +1,66 @@ +# Variable: -- +# Condition: +# Rule: +Authorities: + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: xxx. + Document: IG v3.4 + Item: Item 3.b. + Section: '2.6' + - Cited Guidance: yyyyyyy. + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0999 + Version: '2' + Version: '2.0' + Version: '3.4' + +Check: + all: + - name: variable_name + operator: equal_to + value: library_variable_name + - name: variable_name + operator: equal_to + value: define_variable_name + - name: library_variable_ccode + operator: not_equal_to + value: "" + - name: library_variable_ccode + operator: non_empty + - name: library_variable_ccode + operator: not_equal_to + value: define_variable_ccode + +Core: + Id: CDISC.SDTMIG.CG0999 + Status: Draft + Version: '1' +Description: Testing rule type Variables Metadata Check against Define XML and + Library Metadata +Executability: Fully Executable +Outcome: + Message: "Issue with codelist definition in the Define-XML document." + Output Variables: + - variable_name + - library_variable_name + - library_variable_ccode + - library_variable_data_type + - define_variable_name + - define_variable_ccode + +Rule Type: Variable Metadata Check against Define XML and Library Metadata +Scope: + Classes: + Include: + - ALL + Domains: + Include: + - ALL +Sensitivity: Record From bbd5e1ab5a144fd1d4c3b4fd03bcc8456d625c65 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Fri, 28 Nov 2025 16:09:26 +0100 Subject: [PATCH 3/7] fix: correct conditional logic for variable metadata checks --- cdisc_rules_engine/rules_engine.py | 2 -- 1 file changed, 2 deletions(-) diff --git a/cdisc_rules_engine/rules_engine.py b/cdisc_rules_engine/rules_engine.py index 795f8d185..0e8a82297 100644 --- a/cdisc_rules_engine/rules_engine.py +++ b/cdisc_rules_engine/rules_engine.py @@ -324,8 +324,6 @@ def validate_rule( elif ( rule.get("rule_type") == RuleTypes.VARIABLE_METADATA_CHECK_AGAINST_DEFINE.value - or rule.get("rule_type") - == RuleTypes.VARIABLE_METADATA_CHECK_AGAINST_DEFINE_XML_AND_LIBRARY.value ): self.rule_processor.add_comparator_to_rule_conditions( rule, comparator=None, target_prefix="define_" From f855e8044e80f8078a376781734ed15e6e6831c4 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Mon, 1 Dec 2025 16:10:46 +0100 Subject: [PATCH 4/7] test: update dataset assertions --- .../test_Issues/test_CoreIssue1421.py | 71 +++++++++++++++---- 1 file changed, 58 insertions(+), 13 deletions(-) diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py index ba3c743f0..e4eb952e8 100644 --- a/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py @@ -12,7 +12,7 @@ ) -# @pytest.mark.regression +@pytest.mark.regression def test_validate_define_xml_against_lib_metadata(): command = [ f"{get_python_executable()}", @@ -48,38 +48,83 @@ def test_validate_define_xml_against_lib_metadata(): # Open the Excel file workbook = openpyxl.load_workbook(excel_file_path) - # dataset details - # issue summary - # Go to the "Issue Details" sheet sheet = workbook[issue_datails_sheet] variables_values_column = sheet[issue_sheet_variable_column] - variables_values = [cell.value for cell in variables_values_column[1:] if cell.value is not None] - assert len(variables_values) == 32 + variables_values = [ + cell.value for cell in variables_values_column[1:] if cell.value is not None + ] + assert len(variables_values) == 1 # Ожидаем одну строку, как в реальном результате for value in variables_values: assert len(value.split(",")) == 6 variables_names_column = sheet["H"] - variables_names_values = [cell.value for cell in variables_names_column[1:] if cell.value is not None] - assert len(variables_names_values) == 32 + variables_names_values = [ + cell.value for cell in variables_names_column[1:] if cell.value is not None + ] + assert len(variables_names_values) == 1 for value in variables_names_values: assert len(value.split(",")) == 6 dataset_column = sheet["D"] - dataset_column_values = [cell.value for cell in dataset_column[1:] if cell.value is not None] - assert sorted(set(dataset_column_values)) == ['ae.xpt', 'dm.xpt', 'ec.xpt', 'ex.xpt'] + dataset_column_values = [ + cell.value for cell in dataset_column[1:] if cell.value is not None + ] + assert sorted(set(dataset_column_values)) == ["dm.xpt"] core_id_column = sheet[issue_sheet_coreid_column] - core_id_column_values = [cell.value for cell in core_id_column[1:] if cell.value is not None] + core_id_column_values = [ + cell.value for cell in core_id_column[1:] if cell.value is not None + ] assert set(core_id_column_values) == {"CDISC.SDTMIG.CG0999"} # Go to the "Rules Report" sheet - rules_values = [row for row in workbook[rules_report_sheet].iter_rows(values_only=True)][1:] + rules_values = [ + row for row in workbook[rules_report_sheet].iter_rows(values_only=True) + ][1:] rules_values = [row for row in rules_values if any(row)] assert rules_values[0][0] == "CDISC.SDTMIG.CG0999" assert "SUCCESS" in rules_values[0] - assert rules_values[0][4] == "Issue with codelist definition in the Define-XML document." + assert ( + rules_values[0][4] + == "Issue with codelist definition in the Define-XML document." + ) + + # Go to the "Dataset Details" sheet + dataset_sheet = workbook[dataset_details_sheet] + dataset_values = [row for row in dataset_sheet.iter_rows(values_only=True)][1:] + dataset_values = [row for row in dataset_values if any(row)] + assert len(dataset_values) > 0 + dataset_names = set(row[0] for row in dataset_values if row[0] is not None) + assert dataset_names == {"ae.xpt", "dm.xpt", "ec.xpt", "ex.xpt", "suppec.xpt"} + expected_records = { + "ae.xpt": 74, + "dm.xpt": 18, + "ec.xpt": 1590, + "ex.xpt": 1583, + "suppec.xpt": 13, + } + for row in dataset_values: + dataset_name = row[0] + records_count = row[-1] + assert records_count == expected_records[dataset_name] + + # Go to the "Issue Summary" sheet + issue_summary_sheet = workbook["Issue Summary"] + summary_values = [row for row in issue_summary_sheet.iter_rows(values_only=True)][ + 1: + ] + summary_values = [row for row in summary_values if any(row)] + assert len(summary_values) == 1 + core_ids = set(row[1] for row in summary_values if row[1] is not None) + assert core_ids == {"CDISC.SDTMIG.CG0999"} + # Check Message and dataset columns + assert ( + summary_values[0][2] + == "Issue with codelist definition in the Define-XML document." + ) + assert summary_values[0][0] == "dm.xpt" # Delete the excel file if os.path.exists(excel_file_path): From 8be107f762cb1b51960e6b2ff0f1063260a409d8 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Tue, 2 Dec 2025 16:48:10 +0100 Subject: [PATCH 5/7] minor changes --- tests/QARegressionTests/test_Issues/test_CoreIssue1421.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py index e4eb952e8..11c0c7f2e 100644 --- a/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py +++ b/tests/QARegressionTests/test_Issues/test_CoreIssue1421.py @@ -55,7 +55,7 @@ def test_validate_define_xml_against_lib_metadata(): variables_values = [ cell.value for cell in variables_values_column[1:] if cell.value is not None ] - assert len(variables_values) == 1 # Ожидаем одну строку, как в реальном результате + assert len(variables_values) == 1 for value in variables_values: assert len(value.split(",")) == 6 From a886c9882849da6f7f283a12cdf4a588aafd8b62 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Tue, 9 Dec 2025 15:23:44 +0100 Subject: [PATCH 6/7] correctly load domain for SUPP domains in variable extraction --- .../dataset_builders/base_dataset_builder.py | 10 +++++++--- 1 file changed, 7 insertions(+), 3 deletions(-) diff --git a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py index 2aa8efbf9..72e4c1535 100644 --- a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py +++ b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py @@ -156,9 +156,13 @@ def get_define_xml_variables_metadata(self) -> List[dict]: define_xml_reader = DefineXMLReaderFactory.get_define_xml_reader( self.dataset_path, self.define_xml_path, self.data_service, self.cache ) - return define_xml_reader.extract_variables_metadata( - domain_name=self.dataset_metadata.domain - ) + # If domain is not set and this is a SUPP domain, use rdomain + domain = self.dataset_metadata.domain + if not domain and getattr(self.dataset_metadata, "is_supp", False): + domain = getattr(self.dataset_metadata, "rdomain", None) + if not domain: + return [] + return define_xml_reader.extract_variables_metadata(domain_name=domain) def get_define_xml_value_level_metadata(self) -> List[dict]: """ From cab8c72a506f5e7251ca8692cd09b80c2dfbb293 Mon Sep 17 00:00:00 2001 From: alexfurmenkov Date: Wed, 10 Dec 2025 18:22:45 +0100 Subject: [PATCH 7/7] fix: correctly load variables metadata using domain name and name --- .../dataset_builders/base_dataset_builder.py | 4 ++++ .../define_xml/base_define_xml_reader.py | 21 +++++++++++++------ cdisc_rules_engine/utilities/decorators.py | 11 +++++++++- 3 files changed, 29 insertions(+), 7 deletions(-) diff --git a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py index 72e4c1535..e1e07b1b7 100644 --- a/cdisc_rules_engine/dataset_builders/base_dataset_builder.py +++ b/cdisc_rules_engine/dataset_builders/base_dataset_builder.py @@ -160,6 +160,10 @@ def get_define_xml_variables_metadata(self) -> List[dict]: domain = self.dataset_metadata.domain if not domain and getattr(self.dataset_metadata, "is_supp", False): domain = getattr(self.dataset_metadata, "rdomain", None) + name = getattr(self.dataset_metadata, "name", None) + return define_xml_reader.extract_variables_metadata( + domain_name=domain, name=name + ) if not domain: return [] return define_xml_reader.extract_variables_metadata(domain_name=domain) diff --git a/cdisc_rules_engine/services/define_xml/base_define_xml_reader.py b/cdisc_rules_engine/services/define_xml/base_define_xml_reader.py index a72d55953..fb57c1ea5 100644 --- a/cdisc_rules_engine/services/define_xml/base_define_xml_reader.py +++ b/cdisc_rules_engine/services/define_xml/base_define_xml_reader.py @@ -157,13 +157,15 @@ def extract_domain_metadata(self, domain_name: str = None) -> dict: return domain_metadata_dict @cached("define-variables-metadata") - def extract_variables_metadata(self, domain_name: str = None) -> List[dict]: + def extract_variables_metadata( + self, domain_name: str = None, name: str = None + ) -> List[dict]: logger.info( f"Extracting variables metadata from Define-XML. domain_name={domain_name}" ) try: metadata = self._odm_loader.MetaDataVersion() - domain_metadata = self._get_domain_metadata(metadata, domain_name) + domain_metadata = self._get_domain_metadata(metadata, domain_name, name) variables_metadata = [] codelist_map = self._get_codelist_def_map(metadata.CodeList) for index, itemref in enumerate(domain_metadata.ItemRef): @@ -267,11 +269,18 @@ def _get_dataset_metadata(self, metadata, dataset_name): f"Dataset {dataset_name} is not found in Define XML" ) - def _get_domain_metadata(self, metadata, domain_name): + def _get_domain_metadata(self, metadata, domain_name, name: str = None): try: - domain_metadata = next( - item for item in metadata.ItemGroupDef if item.Domain == domain_name - ) + if name: + domain_metadata = next( + item + for item in metadata.ItemGroupDef + if item.Domain == domain_name and item.Name == name + ) + else: + domain_metadata = next( + item for item in metadata.ItemGroupDef if item.Domain == domain_name + ) return domain_metadata except StopIteration: raise DomainNotFoundInDefineXMLError( diff --git a/cdisc_rules_engine/utilities/decorators.py b/cdisc_rules_engine/utilities/decorators.py index 174754dba..01c12dcf6 100644 --- a/cdisc_rules_engine/utilities/decorators.py +++ b/cdisc_rules_engine/utilities/decorators.py @@ -48,13 +48,20 @@ def cached(cache_key: str): # noqa: C901 """ def format_cache_key( - key: str, args=[], study_id=None, data_bundle_id=None, domain_name=None + key: str, + args=[], + study_id=None, + data_bundle_id=None, + domain_name=None, + name=None, ): """ If a study_id and data_bundle_id are available, cache_key = {study_id}/{data_bundle_id}/key else the function just returns the provided cache key. """ + if name: + key = f"{name}/" + key if domain_name: key = f"{domain_name}/" + key if data_bundle_id: @@ -85,6 +92,7 @@ def inner(*args, **kwargs): if hasattr(instance, "domain") else kwargs.get("domain_name") ) + name = instance.name if hasattr(instance, "name") else kwargs.get("name") if ( hasattr(instance, "cache_service") and instance.cache_service is not None @@ -95,6 +103,7 @@ def inner(*args, **kwargs): study_id=study_id, data_bundle_id=data_bundle_id, domain_name=domain_name, + name=name, ) cached_data = instance.cache_service.get(key) if cached_data is not None: