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1 SDTMIG 3.3 DS 1 STUDYID Study Identifier Char   Identifier Unique identifier for a study. Req Events STUDYID
2 SDTMIG 3.3 DS 2 DOMAIN Domain Abbreviation Char DS Identifier Two-character abbreviation for the domain. Req Events DOMAIN
3 SDTMIG 3.3 DS 3 USUBJID Unique Subject Identifier Char   Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req Events USUBJID
4 SDTMIG 3.3 DS 4 DSSEQ Sequence Number Num   Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req Events SEQ
5 SDTMIG 3.3 DS 5 DSGRPID Group ID Char   Identifier Used to tie together a block of related records in a single domain for a subject. Perm Events GRPID
6 SDTMIG 3.3 DS 6 DSREFID Reference ID Char   Identifier Internal or external identifier. Perm Events REFID
7 SDTMIG 3.3 DS 7 DSSPID Sponsor-Defined Identifier Char   Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Disposition page. Perm Events SPID
8 SDTMIG 3.3 DS 8 DSTERM Reported Term for the Disposition Event Char   Topic Verbatim name of the event or protocol milestone. Some terms in DSTERM will match DSDECOD, but others, such as "Subject moved" will map to controlled terminology in DSDECOD, such as "LOST TO FOLLOW-UP". Req Events TERM
9 SDTMIG 3.3 DS 9 DSDECOD Standardized Disposition Term Char (NCOMPLT), (PROTMLST) Synonym Qualifier Controlled terminology for the name of disposition event or protocol milestone. Examples of protocol milestones: "INFORMED CONSENT OBTAINED", "RANDOMIZED". There are separate codelists used for DSDECOD where the choice depends on the value of DSCAT. Codelist "NCOMPLT" is used for disposition events and codelist "PROTMLST" is used for protocol milestones. The variable may be subject to controlled terminology for other events. Req Events DECOD
10 SDTMIG 3.3 DS 10 DSCAT Category for Disposition Event Char (DSCAT) Grouping Qualifier Used to define a category of related records. Exp Events CAT
11 SDTMIG 3.3 DS 11 DSSCAT Subcategory for Disposition Event Char   Grouping Qualifier A further categorization of DSCAT (e.g., "STUDY PARTICIPATION", "STUDY TREATMENT" when DSCAT = "DISPOSITION EVENT"). Perm Events SCAT
12 SDTMIG 3.3 DS 12 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the event. Perm Events EPOCH
13 SDTMIG 3.3 DS 13 DSDTC Date/Time of Collection Char ISO 8601 Timing Collection date and time of the disposition observation represented in ISO 8601 character format. Perm Events DTC
14 SDTMIG 3.3 DS 14 DSSTDTC Start Date/Time of Disposition Event Char ISO 8601 Timing Start date/time of the disposition event in ISO 8601 character format. Exp Events STDTC
15 SDTMIG 3.3 DS 15 DSDY Study Day of Collection Num   Timing Start date/time of the disposition event in ISO 8601 character format. Exp Events DY
16 SDTMIG 3.3 DS 16 DSSTDY Study Day of Start of Disposition Event Num   Timing Study day of start of event relative to the sponsor-defined RFSTDTC. Perm Events STDY

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CODE
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NCI_PREFERRED_TERM
1 2020-03-27 DSCAT DISPOSITION EVENT     .   C74558 Category for Disposition Event No CDISC SDTM Category For Disposition Event Terminology The group of incidents that occur during a clinical trial and describe whether a subject completed the study epoch or the reason this event did not occur. The subject's disposition is often described for each phase of the study. Disposition Event C74590 Protocol Disposition Event
2 2020-03-27 DSCAT OTHER EVENT     .   C74558 Category for Disposition Event No CDISC SDTM Category For Disposition Event Terminology Other important events that occur during a trial but are not driven by protocol requirements. Other Event C150824 Non-Protocol Disposition Event
3 2020-03-27 DSCAT PROTOCOL MILESTONE     .   C74558 Category for Disposition Event No CDISC SDTM Category For Disposition Event Terminology Occurrences within some epochs that are initiated by a protocol-specified event. The most common protocol milestone is "Informed Consent Obtained" which usually documents the start of the study. Protocol Milestone C74588 Protocol Milestone
4 2020-03-27 EPOCH BASELINE     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study after eligibility has been met and before the start of treatment, at which baseline measurements are collected.   C125938 Baseline Epoch
5 2020-03-27 EPOCH BLINDED TREATMENT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects receive blinded therapeutic treatment.   C102255 Blinded Treatment Epoch
6 2020-03-27 EPOCH CONTINUATION TREATMENT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects receive continuation treatment. Continuation Phase C123452 Continuation Therapy Epoch
7 2020-03-27 EPOCH FOLLOW-UP     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded.   C99158 Clinical Study Follow-up
8 2020-03-27 EPOCH INDUCTION TREATMENT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects receive induction treatment. Induction Phase; Intensive Phase C123453 Induction Therapy Epoch
9 2020-03-27 EPOCH LONG-TERM FOLLOW-UP     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which information about the health status of an individual is obtained long after study interventions have concluded.   C16032 Long-term Follow-up
10 2020-03-27 EPOCH OBSERVATION     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects are observed, without any planned intervention.   C165873 Observation Study Epoch
11 2020-03-27 EPOCH OPEN LABEL TREATMENT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects receive open label therapeutic treatment.   C102256 Open Label Treatment Epoch
12 2020-03-27 EPOCH RUN-IN     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason.   C98779 Run-in Period
13 2020-03-27 EPOCH SCREENING     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects are evaluated for participation in the study.   C48262 Trial Screening
14 2020-03-27 EPOCH TREATMENT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period in a clinical study during which subjects receive investigational product.   C101526 Treatment Epoch
15 2020-03-27 EPOCH WASHOUT     .   C99079 Epoch Yes CDISC SDTM Epoch Terminology A period of time during a clinical study when a participant is taken off of a study drug or other medication in order to eliminate the effects of the treatment.   C42872 Washout Period
16 2020-03-27 NCOMPLT ADVERSE EVENT     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary)   C41331 Adverse Event
17 2020-03-27 NCOMPLT COMPLETED     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI)   C25250 Complete
18 2020-03-27 NCOMPLT DEATH     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology The absence of life or state of being dead. (NCI) Died C28554 Dead
19 2020-03-27 NCOMPLT DISEASE RELAPSE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology The return of a disease after a period of remission. Recurrent Disease C38155 Recurrent Disease
20 2020-03-27 NCOMPLT FAILURE TO MEET CONTINUATION CRITERIA     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject has not been able to meet protocol-defined continuation criteria and will not continue to participate in the clinical trial.   C139236 Failure To Meet Continuation Criteria
21 2020-03-27 NCOMPLT FAILURE TO MEET RANDOMIZATION CRITERIA     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject has been unable to fulfill/satisfy the criteria required for assignment into a randomized group.   C105448 Failure to Meet Randomization Criteria
22 2020-03-27 NCOMPLT LACK OF EFFICACY     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology The lack of expected or desired effect related to a therapy. (NCI)   C48226 Lack of Efficacy
23 2020-03-27 NCOMPLT LOST TO FOLLOW-UP     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology The loss or lack of continuation of a subject to follow-up.   C48227 Lost To Follow-Up
24 2020-03-27 NCOMPLT MET ELIGIBILITY CRITERIA BUT NOT NEEDED     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject met inclusion/exclusion criteria but was not needed in the trial. Passed Screening But Not Needed; Qualified But Not Needed; Reserve, Not Used C150884 Subject Met Eligibility Criteria But Was Not Needed
25 2020-03-27 NCOMPLT NO LONGER CLINICALLY BENEFITING     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a treatment or therapy was changed or discontinued because it is no longer clinically beneficial to the subject or patient, based on the primary therapeutic objective for which it is being administered and assessed. (Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. Scher HI, Morris MJ, Stadler WM, et al.; Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18.) NLCB C156551 No Longer Clinically Benefiting
26 2020-03-27 NCOMPLT NON-COMPLIANCE WITH NON-STUDY DEVICE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a subject has not followed the instructions related to a device that is not under study.   C139240 Non-Compliance With Non-Study Device
27 2020-03-27 NCOMPLT NON-COMPLIANCE WITH STUDY DEVICE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a subject has not followed the instructions related to a device under study.   C139241 Non-Compliance With Study Device
28 2020-03-27 NCOMPLT NON-COMPLIANCE WITH STUDY DRUG     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)   C49631 Non-Compliance With Study Drug
29 2020-03-27 NCOMPLT NON-COMPLIANCE WITH STUDY SCHEDULE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a subject has not followed the schedule of study activities.   C161411 Non-Compliance With Study Schedule
30 2020-03-27 NCOMPLT OTHER     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology Different than the one(s) previously specified or mentioned. (NCI) Other C17649 Other
31 2020-03-27 NCOMPLT PHYSICIAN DECISION     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A position, opinion or judgment reached after consideration by a physician with reference to subject. (NCI)   C48250 Physician Decision
32 2020-03-27 NCOMPLT PREGNANCY     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology Pregnancy is the state or condition of having a developing embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. (NCI)   C25742 Pregnancy
33 2020-03-27 NCOMPLT PROGRESSIVE DISEASE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A disease process that is increasing in extent or severity. (NCI) Disease Progression; Progressive Disease C35571 Progressive Disease
34 2020-03-27 NCOMPLT PROTOCOL DEVIATION     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE: Good clinical practice recommends that deviations be summarized by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed. Compare to protocol violation. [See ICH E3] (CDISC Glossary)   C50996 Protocol Deviation
35 2020-03-27 NCOMPLT PROTOCOL VIOLATION     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per-protocol analysis, and may require that the subject(s) who violate the protocol be discontinued from the study. Compare to protocol deviation. (CDISC Glossary)   C142185 Protocol Violation
36 2020-03-27 NCOMPLT PROTOCOL-SPECIFIED WITHDRAWAL CRITERION MET     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the patient has met one or multiple protocol-specified withdrawal criteria and has been removed from the study.   C142349 Protocol-Specified Withdrawal Criterion Met
37 2020-03-27 NCOMPLT RANDOMIZED BY MISTAKE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject was randomized but should not have been.   C139237 Randomized By Mistake
38 2020-03-27 NCOMPLT RANDOMIZED BY MISTAKE WITH STUDY TREATMENT     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject was randomized but should not have been and study treatment was received in error.   C139238 Randomized By Mistake With Study Treatment
39 2020-03-27 NCOMPLT RANDOMIZED BY MISTAKE WITHOUT STUDY TREATMENT     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject was randomized but should not have been however no study treatment was received.   C139239 Randomized By Mistake Without Study Treatment
40 2020-03-27 NCOMPLT RECOVERY     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A healing process and/or an outcome implying relative health. The term is typically used in the context of direct and indirect effects of sickness or injury. (NCI)   C25746 Recovery
41 2020-03-27 NCOMPLT SCREEN FAILURE     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology The potential subject who does not meet eligibility criteria during the screening period.   C49628 Trial Screen Failure
42 2020-03-27 NCOMPLT SCREENING NOT COMPLETED     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the subject did not complete the screening process.   C166074 Screening Not Completed
43 2020-03-27 NCOMPLT SITE TERMINATED BY SPONSOR     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a clinical study was stopped at a particular site by its sponsor. (NCI)   C106576 Trial Site Terminated by Sponsor
44 2020-03-27 NCOMPLT SPONSOR REQUEST     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that the study subject was removed from the study at the sponsor's request.   C161410 Subject Removed at Sponsor Request
45 2020-03-27 NCOMPLT STUDY TERMINATED BY SPONSOR     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a clinical study was stopped by its sponsor. (NCI)   C49632 Study Terminated By Sponsor
46 2020-03-27 NCOMPLT TECHNICAL PROBLEMS     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology A problem with some technical aspect of a clinical study, usually related to an instrument. (NCI)   C49633 Technical Problem
47 2020-03-27 NCOMPLT WITHDRAWAL BY PARENT/GUARDIAN     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a study participant has been removed from the study by the parent or legal guardian.   C102355 Study Subject Withdrawal by Parent or Guardian
48 2020-03-27 NCOMPLT WITHDRAWAL BY SUBJECT     .   C66727 Completion/Reason for Non-Completion Yes CDISC SDTM Reason for Non-Completion Terminology An indication that a study participant has removed themself from the study.   C49634 Withdrawal by Subject
49 2020-03-27 PROTMLST ELIGIBILITY CRITERIA MET     .   C114118 Protocol Milestone Yes CDISC SDTM Protocol Milestone Terminology The subject has fulfilled the criteria needed to enter or continue in the study.   C132447 Eligibility Criteria Met By Subject
50 2020-03-27 PROTMLST ENTERED INTO TRIAL     .   C114118 Protocol Milestone Yes CDISC SDTM Protocol Milestone Terminology The subject has met eligibility criteria and is enrolled in the study. The subject may or may not subsequently be randomized.   C161417 Subject Entered Into Trial
51 2020-03-27 PROTMLST INFORMED ASSENT OBTAINED     .   C114118 Protocol Milestone Yes CDISC SDTM Protocol Milestone Terminology Assent given by a minor or adult who is unable to give informed consent on their own behalf, to participate in a clinical trial. Assent must be accompanied by consent from a parent or legal guardian for full participation in the study.   C161418 Informed Assent
52 2020-03-27 PROTMLST INFORMED CONSENT OBTAINED     .   C114118 Protocol Milestone Yes CDISC SDTM Protocol Milestone Terminology Consent given by a subject, or in the case of an individual that can only give assent, by a parent or legal guardian, for the participation in a clinical study only after having achieved an understanding of both the relevant medical facts and the relevant risks involved.   C16735 Informed Consent
53 2020-03-27 PROTMLST RANDOMIZED     .   C114118 Protocol Milestone Yes CDISC SDTM Protocol Milestone Terminology Participants are assigned to arms of a clinical trial by chance.   C114209 Subject is Randomized

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1 2020-03-27 DSCAT Single DISPOSITION EVENT       .   C74590 C74558   No   Category for Disposition Event    
2 2020-03-27 DSCAT Single OTHER EVENT       .   C150824 C74558   No   Category for Disposition Event    
3 2020-03-27 DSCAT Single PROTOCOL MILESTONE       .   C74588 C74558   No   Category for Disposition Event    
4 2020-03-27 EPOCH Single BASELINE       .   C125938 C99079   Yes   Epoch    
5 2020-03-27 EPOCH Single BLINDED TREATMENT       .   C102255 C99079   Yes   Epoch    
6 2020-03-27 EPOCH Single CONTINUATION TREATMENT       .   C123452 C99079   Yes   Epoch    
7 2020-03-27 EPOCH Single FOLLOW-UP       .   C99158 C99079   Yes   Epoch    
8 2020-03-27 EPOCH Single INDUCTION TREATMENT       .   C123453 C99079   Yes   Epoch    
9 2020-03-27 EPOCH Single LONG-TERM FOLLOW-UP       .   C16032 C99079   Yes   Epoch    
10 2020-03-27 EPOCH Single OBSERVATION       .   C165873 C99079   Yes   Epoch    
11 2020-03-27 EPOCH Single OPEN LABEL TREATMENT       .   C102256 C99079   Yes   Epoch    
12 2020-03-27 EPOCH Single RUN-IN       .   C98779 C99079   Yes   Epoch    
13 2020-03-27 EPOCH Single SCREENING       .   C48262 C99079   Yes   Epoch    
14 2020-03-27 EPOCH Single TREATMENT       .   C101526 C99079   Yes   Epoch    
15 2020-03-27 EPOCH Single WASHOUT       .   C42872 C99079   Yes   Epoch    
16 2020-03-27 NCOMPLT Single ADVERSE EVENT       .   C41331 C66727   Yes   Completion/Reason for Non-Completion    
17 2020-03-27 NCOMPLT Single COMPLETED       .   C25250 C66727   Yes   Completion/Reason for Non-Completion    
18 2020-03-27 NCOMPLT Single DEATH       .   C28554 C66727   Yes   Completion/Reason for Non-Completion    
19 2020-03-27 NCOMPLT Single DISEASE RELAPSE       .   C38155 C66727   Yes   Completion/Reason for Non-Completion    
20 2020-03-27 NCOMPLT Single FAILURE TO MEET CONTINUATION CRITERIA       .   C139236 C66727   Yes   Completion/Reason for Non-Completion    
21 2020-03-27 NCOMPLT Single FAILURE TO MEET RANDOMIZATION CRITERIA       .   C105448 C66727   Yes   Completion/Reason for Non-Completion    
22 2020-03-27 NCOMPLT Single LACK OF EFFICACY       .   C48226 C66727   Yes   Completion/Reason for Non-Completion    
23 2020-03-27 NCOMPLT Single LOST TO FOLLOW-UP       .   C48227 C66727   Yes   Completion/Reason for Non-Completion    
24 2020-03-27 NCOMPLT Single MET ELIGIBILITY CRITERIA BUT NOT NEEDED       .   C150884 C66727   Yes   Completion/Reason for Non-Completion    
25 2020-03-27 NCOMPLT Single NO LONGER CLINICALLY BENEFITING       .   C156551 C66727   Yes   Completion/Reason for Non-Completion    
26 2020-03-27 NCOMPLT Single NON-COMPLIANCE WITH NON-STUDY DEVICE       .   C139240 C66727   Yes   Completion/Reason for Non-Completion    
27 2020-03-27 NCOMPLT Single NON-COMPLIANCE WITH STUDY DEVICE       .   C139241 C66727   Yes   Completion/Reason for Non-Completion    
28 2020-03-27 NCOMPLT Single NON-COMPLIANCE WITH STUDY DRUG       .   C49631 C66727   Yes   Completion/Reason for Non-Completion    
29 2020-03-27 NCOMPLT Single NON-COMPLIANCE WITH STUDY SCHEDULE       .   C161411 C66727   Yes   Completion/Reason for Non-Completion    
30 2020-03-27 NCOMPLT Single OTHER       .   C17649 C66727   Yes   Completion/Reason for Non-Completion    
31 2020-03-27 NCOMPLT Single PHYSICIAN DECISION       .   C48250 C66727   Yes   Completion/Reason for Non-Completion    
32 2020-03-27 NCOMPLT Single PREGNANCY       .   C25742 C66727   Yes   Completion/Reason for Non-Completion    
33 2020-03-27 NCOMPLT Single PROGRESSIVE DISEASE       .   C35571 C66727   Yes   Completion/Reason for Non-Completion    
34 2020-03-27 NCOMPLT Single PROTOCOL DEVIATION       .   C50996 C66727   Yes   Completion/Reason for Non-Completion    
35 2020-03-27 NCOMPLT Single PROTOCOL VIOLATION       .   C142185 C66727   Yes   Completion/Reason for Non-Completion    
36 2020-03-27 NCOMPLT Single PROTOCOL-SPECIFIED WITHDRAWAL CRITERION MET       .   C142349 C66727   Yes   Completion/Reason for Non-Completion    
37 2020-03-27 NCOMPLT Single RANDOMIZED BY MISTAKE       .   C139237 C66727   Yes   Completion/Reason for Non-Completion    
38 2020-03-27 NCOMPLT Single RANDOMIZED BY MISTAKE WITH STUDY TREATMENT       .   C139238 C66727   Yes   Completion/Reason for Non-Completion    
39 2020-03-27 NCOMPLT Single RANDOMIZED BY MISTAKE WITHOUT STUDY TREATMENT       .   C139239 C66727   Yes   Completion/Reason for Non-Completion    
40 2020-03-27 NCOMPLT Single RECOVERY       .   C25746 C66727   Yes   Completion/Reason for Non-Completion    
41 2020-03-27 NCOMPLT Single SCREEN FAILURE       .   C49628 C66727   Yes   Completion/Reason for Non-Completion    
42 2020-03-27 NCOMPLT Single SCREENING NOT COMPLETED       .   C166074 C66727   Yes   Completion/Reason for Non-Completion    
43 2020-03-27 NCOMPLT Single SITE TERMINATED BY SPONSOR       .   C106576 C66727   Yes   Completion/Reason for Non-Completion    
44 2020-03-27 NCOMPLT Single SPONSOR REQUEST       .   C161410 C66727   Yes   Completion/Reason for Non-Completion    
45 2020-03-27 NCOMPLT Single STUDY TERMINATED BY SPONSOR       .   C49632 C66727   Yes   Completion/Reason for Non-Completion    
46 2020-03-27 NCOMPLT Single TECHNICAL PROBLEMS       .   C49633 C66727   Yes   Completion/Reason for Non-Completion    
47 2020-03-27 NCOMPLT Single WITHDRAWAL BY PARENT/GUARDIAN       .   C102355 C66727   Yes   Completion/Reason for Non-Completion    
48 2020-03-27 NCOMPLT Single WITHDRAWAL BY SUBJECT       .   C49634 C66727   Yes   Completion/Reason for Non-Completion    
49 2020-03-27 PROTMLST Single ELIGIBILITY CRITERIA MET       .   C132447 C114118   Yes   Protocol Milestone    
50 2020-03-27 PROTMLST Single ENTERED INTO TRIAL       .   C161417 C114118   Yes   Protocol Milestone    
51 2020-03-27 PROTMLST Single INFORMED ASSENT OBTAINED       .   C161418 C114118   Yes   Protocol Milestone    
52 2020-03-27 PROTMLST Single INFORMED CONSENT OBTAINED       .   C16735 C114118   Yes   Protocol Milestone    
53 2020-03-27 PROTMLST Single RANDOMIZED       .   C114209 C114118   Yes   Protocol Milestone