ti

ti

Trial Inclusion/ Exclusion Criteria

Structure: One record per I/E criterion

from pharmadata import cdiscpilotsdtm

meta = cdiscpilotsdtm.meta('ti')
print(f"Rows: {meta.number_rows:,}  Columns: {meta.number_columns}")
Rows: 31  Columns: 5

Variables

Show variable specs
shape: (5, 5)
variablelabeltypemandatoryrole
strstrstrstrstr
"STUDYID""Study Identifier""String""Yes""IDENTIFIER"
"DOMAIN""Domain Abbreviation""String""Yes""IDENTIFIER"
"IETESTCD""Inclusion/Exclusion Criterion Short Name""String""Yes""TOPIC"
"IETEST""Inclusion/Exclusion Criterion""String""Yes""SYNONYM QUALIFIER"
"IECAT""Inclusion/Exclusion Category""String""Yes""GROUPING QUALIFIER"

Examples

from great_docs import tbl_explorer
from pharmadata import cdiscpilotsdtm

tbl_explorer(cdiscpilotsdtm.ti.head(10))
PolarsRows10Columns5
STUDYID
str
DOMAIN
str
IETESTCD
str
IETEST
str
IECAT
str
0 CDISCPILOT01 TI INCL01 Males and postmenopausal females at least 50 years of age. INCLUSION
1 CDISCPILOT01 TI INCL02 Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines (Protocol Attachment LZZT.7). INCLUSION
2 CDISCPILOT01 TI INCL03 MMSE score of 10 to 23. INCLUSION
3 CDISCPILOT01 TI INCL04 Modified Hachinski Ischemic Scale score of <= 4. (Protocol Attachment LZZT.8). INCLUSION
4 CDISCPILOT01 TI INCL05 CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. INCLUSION
5 CDISCPILOT01 TI INCL06 Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver. INCLUSION
6 CDISCPILOT01 TI INCL07 Geographic proximity to investigator's site that allows adequate follow-up. INCLUSION
7 CDISCPILOT01 TI INCL08 Caregiverwill monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. INCLUSION
8 CDISCPILOT01 TI EXCL09 Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of xanomeline. EXCLUSION
9 CDISCPILOT01 TI EXCL10 Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study. EXCLUSION