from pharmadata import pharmaverseadam
meta = pharmaverseadam.meta('adtr_onco')
print(f"Rows: {meta.number_rows:,} Columns: {meta.number_columns}")Rows: 181 Columns: 99adtr_onco
adtr_onco
Tumor Results Analysis for Oncology
Structure: One or more records per subject per analysis parameter per analysis timepoint
Variables
Show variable specs
shape: (99, 5)
| variable | label | type | mandatory | role |
|---|---|---|---|---|
| str | str | str | str | str |
| "STUDYID" | "Study Identifier" | "String" | "Yes" | "Identifier Variables for BDS Datasets" |
| "USUBJID" | "Unique Subject Identifier" | "String" | "Yes" | "Identifier Variables for BDS Datasets" |
| "SUBJID" | "Subject Identifier for the Study" | "String" | "No" | "Identifier Variables for BDS Datasets" |
| "SITEID" | "Study Site Identifier" | "String" | "No" | "Identifier Variables for BDS Datasets" |
| "COUNTRY" | "Country" | "String" | "No" | null |
| "DOMAIN" | "Domain Abbreviation" | "String" | "No" | null |
| "RFSTDTC" | "Subject Reference Start Date/Time" | "String" | "No" | null |
| "RFENDTC" | "Subject Reference End Date/Time" | "String" | "No" | null |
| "RFXSTDTC" | "Date/Time of First Study Treatment" | "String" | "No" | null |
| "RFXENDTC" | "Date/Time of Last Study Treatment" | "String" | "No" | null |
| "RFPENDTC" | "Date/Time of End of Participation" | "String" | "No" | null |
| "SCRFDT" | "Screen Failure Date" | "Date" | "No" | null |
| "FRVDT" | "Final Retrieval Visit Date" | "Date" | "No" | null |
| "DTHDTC" | "Date/Time of Death" | "String" | "No" | null |
| "DTHADY" | "Relative Day of Death" | "Float64" | "No" | null |
| "DTHFL" | "Subject Death Flag" | "String" | "No" | null |
| "LDDTHELD" | "Elapsed Days from Last Dose to Death" | "Float64" | "No" | null |
| "LDDTHGR1" | "Last Dose to Death - Days Elapsed Grp 1" | "String" | "No" | null |
| "DTH30FL" | "Death Within 30 Days of Last Trt Flag" | "String" | "No" | null |
| "DTHA30FL" | "Death After 30 Days from Last Trt Flag" | "String" | "No" | null |
| "DTHDOM" | "Domain for Date of Death Collection" | "String" | "No" | null |
| "DTHB30FL" | "Death Within 30 Days of First Trt Flag" | "String" | "No" | null |
| "ASEQ" | "Analysis Sequence Number" | "Int32" | "No" | "Identifier Variables for BDS Datasets" |
| "REGION1" | "Geographic Region 1" | "String" | "No" | null |
| "DMDTC" | "Date/Time of Collection" | "String" | "No" | null |
| "DMDY" | "Study Day of Collection" | "Float64" | "No" | null |
| "AGE" | "Age" | "Float64" | "No" | "ADSL Subject Demographics Variables" |
| "AGEU" | "Age Units" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "AGEGR1" | "Pooled Age Group 1" | "String" | "No" | null |
| "SEX" | "Sex" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "RACE" | "Race" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "RACEGR1" | "Pooled Race Group 1" | "String" | "No" | null |
| "ETHNIC" | "Ethnicity" | "String" | "No" | null |
| "SAFFL" | "Safety Population Flag" | "String" | "No" | "ADSL Population Indicator Variables" |
| "PDFL" | "Pharmacodynamic Analysis Set Flag" | "String" | "No" | null |
| "ARM" | "Description of Planned Arm" | "String" | "No" | "ADSL Treatment Variables" |
| "ARMCD" | "Planned Arm Code" | "String" | "No" | null |
| "ACTARM" | "Description of Actual Arm" | "String" | "No" | "ADSL Treatment Variables" |
| "ACTARMCD" | "Actual Arm Code" | "String" | "No" | null |
| "TRT01P" | "Planned Treatment for Period 01" | "String" | "No" | null |
| "TRT01A" | "Actual Treatment for Period 01" | "String" | "No" | null |
| "TRTSDT" | "Date of First Exposure to Treatment" | "Date" | "No" | "ADSL Treatment Timing Variables" |
| "TRTSDTM" | "Datetime of First Exposure to Treatment" | "Datetime" | "No" | "ADSL Treatment Timing Variables" |
| "TRTSTMF" | "Time of First Exposure Imput. Flag" | "String" | "No" | "ADSL Treatment Timing Variables" |
| "TRTEDT" | "Date of Last Exposure to Treatment" | "Date" | "No" | "ADSL Treatment Timing Variables" |
| "TRTEDTM" | "Datetime of Last Exposure to Treatment" | "Datetime" | "No" | "ADSL Treatment Timing Variables" |
| "TRTETMF" | "Time of Last Exposure Imput. Flag" | "String" | "No" | "ADSL Treatment Timing Variables" |
| "EOSSTT" | "End of Study Status" | "String" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "EOSDT" | "End of Study Date" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "RFICDTC" | "Date/Time of Informed Consent" | "String" | "No" | null |
| "RANDDT" | "Date of Randomization" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "LSTALVDT" | "Date Last Known Alive" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "TRTDURD" | "Total Treatment Duration (Days)" | "Float64" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "DTHDT" | "Date of Death" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "DTHCAUS" | "Cause of Death" | "String" | "No" | null |
| "DTHCGR1" | "Cause of Death Reason 1" | "String" | "No" | null |
| "ADT" | "Analysis Date" | "Date" | "No" | "Timing Variables for BDS Datasets" |
| "ADY" | "Analysis Relative Day" | "Float64" | "No" | "Timing Variables for BDS Datasets" |
| "ADTF" | "Analysis Date Imputation Flag" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "AVISIT" | "Analysis Visit" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "AVISITN" | "Analysis Visit (N)" | "Float64" | "No" | "Timing Variables for BDS Datasets" |
| "PARAM" | "Parameter" | "String" | "Yes" | "Analysis Parameter Variables for BDS Datasets" |
| "PARAMCD" | "Parameter Code" | "String" | "Yes" | "Analysis Parameter Variables for BDS Datasets" |
| "PARCAT1" | "Parameter Category 1" | "String" | "No" | null |
| "PARCAT2" | "Parameter Category 2" | "String" | "No" | null |
| "PARCAT3" | "Parameter Category 3" | "String" | "No" | null |
| "AVAL" | "Analysis Value" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "BASE" | "Baseline Value" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "CHG" | "Change from Baseline" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "PCHG" | "Percent Change from Baseline" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "NADIR" | "NADIR" | "Float64" | "No" | null |
| "CHGNAD" | "Change from NADIR" | "Float64" | "No" | null |
| "PCHGNAD" | "Percent Change from NADIR" | "Float64" | "No" | null |
| "ABLFL" | "Baseline Record Flag" | "String" | "No" | "Flag Variables for BDS Datasets" |
| "ANL01FL" | "Analysis Flag 01" | "String" | "No" | null |
| "ANL02FL" | "Analysis Flag 02" | "String" | "No" | null |
| "ANL03FL" | "Analysis Flag 03" | "String" | "No" | null |
| "ANL04FL" | "Analysis Flag 04" | "String" | "No" | null |
| "TRSEQ" | "Sequence Number" | "Int32" | "No" | null |
| "TRGRPID" | "Group ID" | "String" | "No" | null |
| "TRLNKID" | "Link ID" | "String" | "No" | null |
| "TRTESTCD" | "Tumor/Lesion Assessment Short Name" | "String" | "No" | null |
| "TRTEST" | "Tumor/Lesion Assessment Test Name" | "String" | "No" | null |
| "TRORRES" | "Result or Finding in Original Units" | "String" | "No" | null |
| "TRORRESU" | "Original Units" | "String" | "No" | null |
| "TRSTRESC" | "Character Result/Finding in Std Format" | "String" | "No" | null |
| "TRSTRESN" | "Numeric Result/Finding in Standard Units" | "Float64" | "No" | null |
| "TRSTRESU" | "Standard Units" | "String" | "No" | null |
| "TREVAL" | "Evaluator" | "String" | "No" | null |
| "TREVALID" | "Evaluator Identifier" | "String" | "No" | null |
| "TRACPTFL" | "Accepted Record Flag" | "String" | "No" | null |
| "VISITNUM" | "Visit Number" | "Float64" | "No" | null |
| "VISIT" | "Visit Name" | "String" | "No" | null |
| "TRDTC" | "Date/Time of Tumor/Lesion Measurement" | "String" | "No" | null |
| "TULOC" | "Location of the Tumor/Lesion" | "String" | "No" | null |
| "TULOCGR1" | "Tumor Site Group 1" | "String" | "No" | null |
| "LSEXP" | "Lesion IDs Expected" | "String" | "No" | null |
| "LSASS" | "Lesion IDs Assessed" | "String" | "No" | null |
| "DTHDTF" | "Date of Death Imputation Flag" | "String" | null | null |
Examples
from great_docs import tbl_explorer
from pharmadata import pharmaverseadam
tbl_explorer(pharmaverseadam.adtr_onco.head(10))PolarsRows10Columns99 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STUDYID str |
USUBJID str |
SUBJID str |
SITEID str |
COUNTRY str |
DOMAIN str |
RFSTDTC str |
RFENDTC str |
RFXSTDTC str |
RFXENDTC str |
RFPENDTC str |
SCRFDT date |
FRVDT date |
DTHDTC str |
DTHADY f64 |
DTHFL str |
LDDTHELD f64 |
LDDTHGR1 str |
DTH30FL str |
DTHA30FL str |
DTHDOM str |
DTHB30FL str |
ASEQ i32 |
REGION1 str |
DMDTC str |
DMDY f64 |
AGE f64 |
AGEU str |
AGEGR1 str |
SEX str |
RACE str |
RACEGR1 str |
ETHNIC str |
SAFFL str |
PDFL str |
ARM str |
ARMCD str |
ACTARM str |
ACTARMCD str |
TRT01P str |
TRT01A str |
TRTSDT date |
TRTSDTM dtime |
TRTSTMF str |
TRTEDT date |
TRTEDTM dtime |
TRTETMF str |
EOSSTT str |
EOSDT date |
RFICDTC str |
RANDDT date |
LSTALVDT date |
TRTDURD f64 |
DTHDT date |
DTHCAUS str |
DTHCGR1 str |
ADT date |
ADY f64 |
ADTF str |
AVISIT str |
AVISITN f64 |
PARAM str |
PARAMCD str |
PARCAT1 str |
PARCAT2 str |
PARCAT3 str |
AVAL f64 |
BASE f64 |
CHG f64 |
PCHG f64 |
NADIR f64 |
CHGNAD f64 |
PCHGNAD f64 |
ABLFL str |
ANL01FL str |
ANL02FL str |
ANL03FL str |
ANL04FL str |
TRSEQ i32 |
TRGRPID str |
TRLNKID str |
TRTESTCD str |
TRTEST str |
TRORRES str |
TRORRESU str |
TRSTRESC str |
TRSTRESN f64 |
TRSTRESU str |
TREVAL str |
TREVALID str |
TRACPTFL str |
VISITNUM f64 |
VISIT str |
TRDTC str |
TULOC str |
TULOCGR1 str |
LSEXP str |
LSASS str |
DTHDTF str |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 1 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-02 | 1 | None | BASELINE | 0 | Target Lesion 1 Analysis Diameter | LDIAM1 | Target Lesion(s) | Investigator | RECIST 1.1 | 21 | None | None | None | None | None | None | None | Y | None | None | None | 17 | TARGET | T01 | LDIAM | Longest Diameter | 21 | mm | 21 | 21 | mm | INVESTIGATOR | None | None | 1 | SCREENING | 2014-01-02 | ADRENAL GLAND | NON-NODAL | T01 | T01 | None |
| 1 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 2 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-23 | 22 | None | WEEK 3 | 2 | Target Lesion 1 Analysis Diameter | LDIAM1 | Target Lesion(s) | Investigator | RECIST 1.1 | 20 | None | None | None | None | None | None | None | Y | None | None | None | 41 | TARGET | T01 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm | INVESTIGATOR | None | None | 2 | WEEK 3 | 2014-01-23 | ADRENAL GLAND | NON-NODAL | T01 | T01 | None |
| 2 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 3 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-02-01 | 31 | D | WEEK 6 | 3 | Target Lesion 1 Analysis Diameter | LDIAM1 | Target Lesion(s) | Investigator | RECIST 1.1 | 20 | None | None | None | None | None | None | None | Y | None | None | None | 57 | TARGET | T01 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm | INVESTIGATOR | None | None | 3 | WEEK 6 | 2014-02 | ADRENAL GLAND | NON-NODAL | T01 | T01 | None |
| 3 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 4 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-03-06 | 64 | None | WEEK 9 | 4 | Target Lesion 1 Analysis Diameter | LDIAM1 | Target Lesion(s) | Investigator | RECIST 1.1 | 0 | None | None | None | None | None | None | None | Y | None | None | None | 77 | TARGET | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm | INVESTIGATOR | None | None | 4 | WEEK 9 | 2014-03-06 | ADRENAL GLAND | NON-NODAL | T01 | T01 | None |
| 4 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 5 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-02 | 1 | None | BASELINE | 0 | Target Lesion 2 Analysis Diameter | LDIAM2 | Target Lesion(s) | Investigator | RECIST 1.1 | 33.28 | None | None | None | None | None | None | None | Y | None | None | None | 22 | TARGET | T02 | LDIAM | Longest Diameter | 33.28 | mm | 33.28 | 33.28 | mm | INVESTIGATOR | None | None | 1 | SCREENING | 2014-01-02 | LYMPH NODE | NODAL | T02 | T02 | None |
| 5 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 6 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-23 | 22 | None | WEEK 3 | 2 | Target Lesion 2 Analysis Diameter | LDIAM2 | Target Lesion(s) | Investigator | RECIST 1.1 | 35.7 | None | None | None | None | None | None | None | Y | None | None | None | 46 | TARGET | T02 | LDIAM | Longest Diameter | 35.7 | mm | 35.7 | 35.7 | mm | INVESTIGATOR | None | None | 2 | WEEK 3 | 2014-01-23 | LYMPH NODE | NODAL | T02 | T02 | None |
| 6 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 7 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-03-06 | 64 | None | WEEK 9 | 4 | Target Lesion 2 Analysis Diameter | LDIAM2 | Target Lesion(s) | Investigator | RECIST 1.1 | 7.49 | None | None | None | None | None | None | None | Y | None | None | None | 82 | TARGET | T02 | LDIAM | Longest Diameter | 7.49 | mm | 7.49 | 7.49 | mm | INVESTIGATOR | None | None | 4 | WEEK 9 | 2014-03-06 | LYMPH NODE | NODAL | T02 | T02 | None |
| 7 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 8 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-02 | 1 | None | BASELINE | 0 | Target Lesion 3 Analysis Diameter | LDIAM3 | Target Lesion(s) | Investigator | RECIST 1.1 | 24 | None | None | None | None | None | None | None | Y | None | None | None | 19 | TARGET | T03 | LDIAM | Longest Diameter | 24 | mm | 24 | 24 | mm | INVESTIGATOR | None | None | 1 | SCREENING | 2014-01-02 | BODY | NON-NODAL | T03 | T03 | None |
| 8 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 9 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-01-23 | 22 | None | WEEK 3 | 2 | Target Lesion 3 Analysis Diameter | LDIAM3 | Target Lesion(s) | Investigator | RECIST 1.1 | 24 | None | None | None | None | None | None | None | Y | None | None | None | 43 | TARGET | T03 | LDIAM | Longest Diameter | 24 | mm | 24 | 24 | mm | INVESTIGATOR | None | None | 2 | WEEK 3 | 2014-01-23 | BODY | NON-NODAL | T03 | T03 | None |
| 9 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | TR | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | 10 | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | None | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | 2014-03-06 | 64 | None | WEEK 9 | 4 | Target Lesion 3 Analysis Diameter | LDIAM3 | Target Lesion(s) | Investigator | RECIST 1.1 | 0 | None | None | None | None | None | None | None | Y | None | None | None | 79 | TARGET | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm | INVESTIGATOR | None | None | 4 | WEEK 9 | 2014-03-06 | BODY | NON-NODAL | T03 | T03 | None |