INSTEM01 4 WEEK TOXICITY STUDY IN THE RAT INSTEM01 BWGAIN BWGAINC BW TERMBW FC ALB SERUM Clinical LBMETHOD ALP SERUM Clinical LBMETHOD ALT SERUM Clinical LBMETHOD APTT PLASMA Coagulation LBMETHOD AST SERUM Clinical LBMETHOD BASO WHOLE Hematology LBMETHOD BASOLE WHOLE Hematology LBMETHOD BILI SERUM Clinical LBMETHOD BILI URINE Urinalysis LBMETHOD BUN SERUM Clinical LBMETHOD CA SERUM Clinical LBMETHOD CHOL SERUM Clinical LBMETHOD CL SERUM Clinical LBMETHOD CREAT SERUM Clinical LBMETHOD EOS WHOLE Hematology LBMETHOD EOSLE WHOLE Hematology LBMETHOD FIBRINO PLASMA Coagulation LBMETHOD GLOBUL SERUM Clinical LBMETHOD GLUC SERUM Clinical LBMETHOD GLUC SERUM Urinalysis LBMETHOD GLUC URINE Urinalysis LBMETHOD HCT WHOLE Hematology LBMETHOD HGB WHOLE Hematology LBMETHOD K SERUM Clinical LBMETHOD KETONES URINE Urinalysis LBMETHOD LGLUCLE WHOLE Hematology LBMETHOD LGUNSCE WHOLE Hematology LBMETHOD LYM WHOLE Hematology LBMETHOD LYMLE WHOLE Hematology LBMETHOD MCH WHOLE Hematology LBMETHOD MCHC WHOLE Hematology LBMETHOD MCV WHOLE Hematology LBMETHOD MONO WHOLE Hematology LBMETHOD MONOLE WHOLE Hematology LBMETHOD NEUT WHOLE Hematology LBMETHOD NEUTLE WHOLE Hematology LBMETHOD OCCBLD URINE Urinalysis LBMETHOD PH URINE Urinalysis LBMETHOD PHOS SERUM Clinical LBMETHOD PLAT WHOLE Hematology LBMETHOD PROT SERUM Clinical LBMETHOD PROT URINE Urinalysis LBMETHOD PT PLASMA Coagulation LBMETHOD RBC WHOLE Hematology LBMETHOD RDW WHOLE Hematology LBMETHOD RETI WHOLE Hematology LBMETHOD RETIRBC WHOLE Hematology LBMETHOD SDH SERUM Clinical LBMETHOD SEDEXAM URINE Urinalysis LBMETHOD SODIUM SERUM Clinical LBMETHOD SPERM URINE Urinalysis LBMETHOD SPGRAV URINE Urinalysis LBMETHOD TRIG SERUM Clinical LBMETHOD UROBIL URINE Urinalysis LBMETHOD WBC WHOLE Hematology LBMETHOD TRT PLASMA ANALYTE LC AUCALL PLASMA Treatment NONCOMPARTMENTAL CMAX PLASMA Treatment NONCOMPARTMENTAL TMAX PLASMA Treatment NONCOMPARTMENTAL CLRESMOD MARESMOD MIRESMOD AGETXT AGEU DIET DOSDUR DOSSTDTC ENVTEMP ENVTEMPU EXPENDTC EXPSTDTC FEEDREG GLPTYP HOUSEGRP HUMIDT HUMIDTU IDMETH LIGHT PINV RECSAC ROUTE SDESIGN SLENGTH SNDCTVER SNDIGVER SPECIES SPLANSUB SPLRLOC SPLRNAM SPREFID SRANDOM SSPONSOR SSTYP STCAT STDIR STITLE STRAIN STSTDTC TFCNTRY TRMSAC TRT TRTCAS TRTV TSCNTRY TSLOC TSNAM TSTFLOC TSTFNAM ARMCD GRPLBL SETLBL SPGRPCD TCNTRL TKDESC TRTDOS TRTDOSU Trial Arms ta.xpt Trial Elements te.xpt Trial Summary ts.xpt Trial Sets tx.xpt Comments co.xpt Demographics dm.xpt Subject Elements se.xpt Exposure ex.xpt Disposition ds.xpt Body Weight Gains bg.xpt Body Weight bw.xpt Clinical Observations cl.xpt Food and Water Consumption fw.xpt Laboratory Test Results lb.xpt Macroscopic Findings ma.xpt Microscopic Findings mi.xpt Organ Measurements om.xpt Pharmacokinetic Concentrations pc.xpt Pharmacokinetics Parameters pp.xpt Pooled Definition pooldef.xpt Related Records relrec.xpt Supplemental Qualifiers for CL suppcl.xpt Supplemental Qualifiers for MA suppma.xpt Supplemental Qualifiers for MI suppmi.xpt Study Identifier Domain Abbreviation Planned Arm Code Description of Planned Arm Order of Element within Arm Element Code Description of Element Branch Transition Rule Trial Epoch Study Identifier Domain Abbreviation Element Code Description of Element Rule for Start of Element Rule for End of Element Planned Duration of Element Study Identifier Domain Abbreviation Sequence Number Group Identifier Trial Summary Parameter Short Name Trial Summary Parameter Parameter Value Study Identifier Domain Abbreviation Set Code Set Description Sequence Number Trial Set Parameter Short Name Trial Set Parameter Trial Set Parameter Value Study Identifier Domain Abbreviation Related Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Identifying Variable Identifying Variable Value Comment Reference Comment Evaluator Date/Time of Comment Study Day of Comment Study Identifier Domain Abbreviation Unique Subject Identifier Subject Identifier for the Study Subject Reference Start Date/Time Subject Reference End Date/Time Study Site Identifier Date/Time of Birth Age Age Range Age Unit Sex Species Strain/Substrain Strain/Substrain Details Planned Arm Code Description of Planned Arm Set Code Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Element Code Description of Element Start Date/Time of Element End Date/Time of Element Description of Unplanned Element Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Name of Actual Treatment Dose per Administration Dose Description Dose Units Dose Form Dosing Frequency Per Interval Route of Administration Lot Number Location of Dose Administration Method of Administration Treatment Vehicle Amount Administered Amount Administered Units Reason for Dose Adjustment Start Date/Time of Treatment End Date/Time of Treatment Study Day of Start of Treatment Study Day of End of Treatment Duration of Treatment Planned Time Point Name Planned Time Point Number Planned Elapsed Time from Time Point Ref Time Point Reference Date/Time of Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Disposition Event Standardized Disposition Term Planned Study Day of Disposition Date/Time of Disposition Study Day of Disposition Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Test Short Name Test Name Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Examination Status Reason Not Done Exclusion Flag Reason for Exclusion Date/Time Animal Weighed End Date/Time Animal Weighed Study Day Animal Weighed Study Day of End of Weight Interval Planned Elapsed Time from Time Point Ref Time Point Reference Date/Time of Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Test Short Name Test Name Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Examination Status Reason Not Done Baseline Flag Fasting Status Exclusion Flag Reason for Exclusion Planned Study Day of Collection Date/Time Animal Weighed Study Day Animal Weighed Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Group Identifier Mass Identifier Test Short Name Test Name Category for Clinical Observations Subcategory for Clinical Observations Body System or Organ Class Result or Findings as Collected Standardized Result in Character Format Result Category Examination Status Reason Not Done Location of a Finding Evaluator Severity Exclusion Flag Reason for Exclusion Planned Study Day of Collection Start Date/Time of Observation Study Day of Observation Planned Time Point Name Planned Time Point Number Planned Elapsed Time from Time Point Ref Time Point Reference Date/Time of Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Group Identifier Food /Water Consumption Short Name Food /Water Consumption Name Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Completion Status Reason Not Done Exclusion Flag Reason for Exclusion Date/Time of Observation End Date/Time of Observation Study Day of Observation Study Day of End of Observation Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Group Identifier Specimen Identifier Sponsor-Defined Identifier Lab Test or Examination Short Name Lab Test or Examination Name Category for Lab Test Subcategory for Lab Test Result or Findings as Collected Unit of the Original Result Reference Range Lower Limit-Orig Unit Reference Range Upper Limit-Orig Unit Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Reference Range Lower Limit-Std Unit Reference Range Upper Limit-Std Unit Reference Range for Char Rslt-Std Unit Reference Range Indicator Completion Status Reason Not Done Vendor Name Specimen Type Anatomical Region of Specimen Specimen Condition Specimen Usability for the Test Specimen Collection Location Specimen Laterality within Subject Specimen Directionality within Subject Portion or Totality Method of Test or Examination Baseline Flag Fasting Status Derived Flag Toxicity Standard Toxicity Grade Exclusion Flag Reason for Exclusion Planned Study Day of Collection Date/Time of Specimen Collection End Date/Time of Specimen Collection Study Day of Specimen Collection Study Day of End of Specimen Collection Planned Time Point Name Planned Time Point Number Planned Elapsed Time from Time Point Ref Time Point Reference Date/Time of Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Group Identifier Specimen Reference Identifier Mass Identifier Macroscopic Examination Short Name Macroscopic Examination Name Body System or Organ Class Result or Findings as Collected Standardized Result in Character Format Examination Status Reason Not Done Laboratory Name Specimen Material Type Anatomical Region of Specimen Specimen Condition Specimen Usability for the Test Specimen Laterality within Subject Specimen Directionality within Subject Portion or Totality Evaluator Severity Relationship to Death Date/Time of Collection Study Day of Specimen Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Group Identifier Specimen Reference Identifier Mass Identifier Microscopic Examination Short Name Microscopic Examination Name Body System or Organ Class Result or Findings as Collected Standardized Result in Character Format Result Category Completion Status Reason Not Done Laboratory Name Specimen Material Type Anatomical Region of Specimen Specimen Condition Specimen Usability for the Test Method of Test or Examination Specimen Laterality within Subject Specimen Directionality within Subject Evaluator Severity Relationship to Death Date/Time of Specimen Collection Study Day of Specimen Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Test Short Name Test Name Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Finding Status Reason Not Done Specimen Material Type Anatomical Region of Specimen Specimen Condition Specimen Usability for the Test Specimen Laterality within Subject Specimen Directionality within Subject Portion or Totality Exclusion Flag Reason for Exclusion Date/Time Organ Weighed Study Day of Weighing Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Group Identifier Sample Identifier Sponsor Identifier Test Short Name Test Name Test Category Test Subcategory Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Completion Status Reason Not Done Vendor Name Specimen Material Type Specimen Condition Method of Test or Examination Baseline Flag Fasting Status Derived Flag Lower Limit of Quantitation Exclusion Flag Reason for Exclusion Visit Day Date/Time of Specimen Collection End Date/Time of Specimen Collection Study Day of Specimen Collection Study Day of End of Specimen Collection Planned Time Point Name Planned Time Point Number Planned Elapsed Time from Time Point Ref Time Point Reference Date/Time of Reference Point Evaluation Interval Study Identifier Domain Abbreviation Unique Subject Identifier Pool Identifier Sequence Number Group Identifier Parameter Short Name Parameter Name Parameter Category Parameter Subcategory Result or Findings as Collected Unit of the Original Result Standardized Result in Character Format Standardized Result in Numeric Format Unit of the Standardized Result Completion Status Reason Not Done Specimen Material Type Planned Study Day of Collection Time Point Reference Date/Time of Reference Point Start of Evaluation Interval End of Evaluation Interval Study Identifier Pool Identifier Unique Subject Identifier Study Identifier Related Domain Abbreviation Unique Subject Identifier Pool Identifier Identifying Variable Identifying Variable Value Relationship Type Relationship Identifier Study Identifier Related Domain Abbreviation Unique Subject Identifier Pool Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Related Domain Abbreviation Unique Subject Identifier Pool Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Related Domain Abbreviation Unique Subject Identifier Pool Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Body Weight Gain Cumulative Body Weight Gain Body Weight Terminal Body Weight Food Consumption Albumin Alkaline Phosphatase Alanine Aminotransferase Activated Partial Thromboplastin Time Aspartate Aminotransferase Basophils Basophils/Leukocytes Bilirubin Bilirubin Blood Urea Nitrogen Calcium Cholesterol Chloride Creatinine Eosinophils Eosinophils/Leukocytes Fibrinogen Globulin Glucose Glucose Glucose Hematocrit Hemoglobin Potassium Ketones Large Unstained Cells/Leukocytes Large Unstained Cells Lymphocytes Lymphocytes/Leukocytes Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular HGB Concentration Ery. Mean Corpuscular Volume Monocytes Monocytes/Leukocytes Neutrophils Neutrophils/Leukocytes Occult Blood pH Phosphate Platelets Protein Protein Prothrombin Time Erythrocytes Erythrocytes Distribution Width Reticulocytes Reticulocytes/Erythrocytes Sorbitol Dehydrogenase Sediment Examination Sodium Spermatozoa Specific Gravity Triglycerides Urobilinogen Leukocytes Treatment BI 894416 AUC All Max Conc Time of CMAX Result Modifiers Result Modifiers Result Modifiers Age Text Age Unit Basal Diet Dosing Duration Start Date/Time of Dose Interval Environmental Temperature Environmental Temperature Units Experimental End Date Experimental Start Date Feeding Regimen Good Laboratory Practice Type Housing Group Housing Humidity Housing Humidity Units Method of Identification Light Cycle Principal Investigator Recovery Period Route of Administration Study Design Study Length SEND Controlled Terminology Version SEND Implementation Guide Version Species Planned Number of Subjects Test Subject Supplier Site Test Subject Supplier Sponsor's Reference ID Study Is Randomized Sponsoring Organization Study Type Study Category Study Director Study Title Strain/Substrain Study Start Date Test Facility Country Time to Terminal Sacrifice Investigational Therapy or Treatment Primary Treatment CAS Registry Number Treatment Vehicle Test Site Country Test Site Location Test Site Name Test Facility Location Test Facility Name Arm Code Group Label Set Label Sponsor-Defined Group Code Control Type Toxicokinetic Description Dose Level Dose Units Week BODY WEIGHT GAIN Body Weight Gain Cumulative Body Weight Gain Body Weight Gain Cumulative Body Weight Gain BODY WEIGHT Body Weight Terminal Body Weight Body Weight Terminal Body Weight CLINICAL OBSERVATIONS Clinical Signs COMMENTS UNITED STATES PARALLEL DEMOGRAPHICS DISPOSITION Planned Recovery Sacrifice Planned Terminal Sacrifice EXPOSURE Daily; Per Day SOLUTION FOOD AND WATER CONSUMPTION Food Consumption Food Consumption BILATERAL LABORATORY TEST RESULTS Activated Partial Thromboplastin Time Alanine Aminotransferase; SGPT Albumin; Microalbumin Alkaline Phosphatase Aspartate Aminotransferase; SGOT Basophils Basophils/Leukocytes Bilirubin; Total Bilirubin Blood Urea Nitrogen Calcium Chloride Cholesterol; Total Cholesterol Creatinine Eosinophils Eosinophils/Leukocytes Ery. Mean Corpuscular HGB Concentration Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular Volume; Erythrocytes Mean Corpuscular Volume; RBC Mean Corpuscular Volume Erythrocytes; Red Blood Cells Erythrocytes Distribution Width; Red Blood Cell Distribution Width Fibrinogen Globulin Glucose EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume FHGB; Free Hemoglobin; Hemoglobin Ketones Large Unstained Cells Large Unstained Cells/Leukocytes Leukocytes; White Blood Cells Lymphocytes Lymphocytes/Leukocytes Monocytes Monocytes/Leukocytes Neutrophils Neutrophils/Leukocytes Occult Blood Inorganic Phosphate; Phosphate; Phosphorus Platelets Potassium Protein Prothrombin Time Reticulocytes Reticulocytes/Erythrocytes Microscopic Sediment Analysis; Sediment Analysis; Sediment Examination Sodium Sorbitol Dehydrogenase Specific Gravity Spermatozoa Triglycerides Urobilinogen pH Albumin; Microalbumin Alkaline Phosphatase Alanine Aminotransferase; SGPT Activated Partial Thromboplastin Time Aspartate Aminotransferase; SGOT Basophils Basophils/Leukocytes Bilirubin; Total Bilirubin Blood Urea Nitrogen Calcium Cholesterol; Total Cholesterol Chloride Creatinine Eosinophils Eosinophils/Leukocytes Fibrinogen Globulin Glucose EVF; Erythrocyte Volume Fraction; Hematocrit; PCV; Packed Cell Volume FHGB; Free Hemoglobin; Hemoglobin Potassium Ketones Large Unstained Cells/Leukocytes Large Unstained Cells Lymphocytes Lymphocytes/Leukocytes Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular HGB Concentration Ery. Mean Corpuscular Volume; Erythrocytes Mean Corpuscular Volume; RBC Mean Corpuscular Volume Monocytes Monocytes/Leukocytes Neutrophils Neutrophils/Leukocytes Occult Blood pH Inorganic Phosphate; Phosphate; Phosphorus Platelets Protein Prothrombin Time Erythrocytes; Red Blood Cells Erythrocytes Distribution Width; Red Blood Cell Distribution Width Reticulocytes Reticulocytes/Erythrocytes Sorbitol Dehydrogenase Microscopic Sediment Analysis; Sediment Analysis; Sediment Examination Sodium Spermatozoa Specific Gravity Triglycerides Urobilinogen Leukocytes; White Blood Cells MACROSCOPIC FINDINGS Gross Pathological Examination Gross Pathological Examination MICROSCOPIC FINDINGS Non-neoplastic Disorder Microscopic Examination Microscopic Examination NOT DONE No Yes ORGAN MEASUREMENTS Organ to Body Weight Ratio Organ to Brain Weight Ratio Weight Organ to Brain Weight Ratio Organ to Body Weight Ratio Weight PHARMACOKINETICS CONCENTRATIONS AUC All Max Conc Time of CMAX AUC All Max Conc Time of CMAX Hour; hr h*nmol/L Nanomole per Liter PHARMACOKINETICS PARAMETERS ORAL GAVAGE Clinical Observation Laboratory Data Macroscopic Findings Microscopic Findings SUBJECT ELEMENTS MARKED Slight Trace MODERATE SEVERE Female Male SEND IG Version 3.0 Aorta BONE MARROW SMEAR Bone Marrow, Femoral Bone Marrow, Sternal Bone, Femoral; Femur Sterna; Sternum Brain; Nervous System, Brain Cervix Uteri; Uterine Cervix EPIDIDYMIS ESOPHAGUS Eye; Eyeball GLAND, ADRENAL GLAND, HARDERIAN GLAND, MAMMARY GLAND, PARATHYROID Hypophysis; Hypophysis Cerebri GLAND, PROSTATE Parotid Gland Gland, Salivary, Mandibular; Submaxillary Gland GLAND, SALIVARY, SUBMANDIBULAR/GLAND, SALIVARY, SUBLINGUAL Seminal Sacs GLAND, THYROID Cardiac; Heart KIDNEY Cecal; Cecum Colon LARGE INTESTINE, RECTUM Larynx LIVER LUNG Axillary Lymph Node LYMPH NODE, MESENTERIC Skeletal Muscle Tissue Optic Nerve Sciatic Nerve Ovary Fallopian Tube PANCREAS PEYER'S PATCH PLASMA Sera SKIN/SUBCUTIS SMALL INTESTINE, DUODENUM Ileum Jejunum Medulla Spinalis SPLEEN STOMACH Testicle; Testis THYMUS Tongue Trachea; Windpipe Ureter Bladder; Urinary System, Bladder URINE Womb Vagina WHOLE BLOOD RAT FDA RPS Toxicology: Repeat Dose Toxicity Toxicology WH TRIAL ARMS TRIAL ELEMENTS TRIAL SUMMARY TRIAL SETS Percentage per High Powered Field per Low Powered Field 10^6/mm3; 10^6/uL; T/L; TI/L; Tera/L 10^3/mm3; 10^3/uL; 10^6/mL; G/L; GI/L; Giga per Liter Degree Fahrenheit Unit per Liter; mU/mL Cubic Micrometer; Cubic Micron; Femtoliter; um3 Gram Gram per Deciliter; g% Milligram per Deciliter; mg% Milligram per Kilogram per Day Micromole per Milliliter; Millimole per Liter; Mole per Cubic Meter; mcmol/mL; mmol/L; mol/m3; nmol/uL; umol/mL Picogram Second Microliter; mcL; mm3 If birth date is collected, this animal's start date on the dosing phase (RFSTDTC) minus Birth date+1, otherwise this is the age of the animal at the start of the study if that is defined in the study protocol. Y for last non missing record on or before the first dose date (RFSTDTC); otherwise Null Actual amount of test article in the dose administered: EXVAMT * Dose concentration "--DTC minus RFSTDTC plus 1 if --DTC is on or after RFSTDTC. --DTC minus RFSTDTC if --DTC precedes RFSTDTC." "--ENDTC minus RFSTDTC plus 1 if --ENDTC is on or after RFSTDTC. --ENDTC minus RFSTDTC if --ENDTC precedes RFSTDTC." The total amount of food consumed during the interval divided by the number of animals in the cage * number of cage days in the interval Sequential number identifying records within a dataset "--STDTC minus RFSTDTC plus 1 if --STDTC is on or after RFSTDTC. --STDTC minus RFSTDTC if --STDTC precedes RFSTDTC" Copy of --ORRES When --STRESC contains a numeric result, the numeric equivalent is reported in --STRESN WHEN --STRESC contains a numeric result, --ORRESU is reported in --STRESU Derived from the organ/tissue name used during sample collection. A value assigned to each unique session name that is reported in --TPT. Concatenation of STUDYID-SUBJID Set equal to associated domain --DY except when activity was performed on a different day than planned or activity was unscheduled. This is populated only if an age range rather than a specific age or birth date is recorded for the study animals Mapped from the collected clinical signs category A concatenation of the individual observation components collected Translated from collected DSTERM to controlled terminology FWORRESU/animal/day Mapped from the test name used during sample collection Derived from the test name used during sample collection A concatenation of the individual observation components collected A concatenation of the individual observation components collected Not populated Not Populated Difference between values in BWORRES values for interval specified Animal's date of death on the study. If animal did not die during the study this is the study end date. Animal's start date of the dosing phase If not populated, see the TS domain entry. If not populated, see the TS domain entry. Mapped from test name used during data collection Sequential number identifying records in the domain Sequential number identifying records in the domain Unit that body weight was collected in, from BWORRESU