Rhabdomyosarcoma

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1	INFO	Title	Rhabdomyosarcoma (RMS) Data Dictionary
2	INFO	Name	rms_dev
3	INFO	Release Notes
4	INFO	Parent Data Model	pcdc_dev
5	INFO	License	Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/)
6	INFO	D4CG Data Modeling Wiki	https://docs.pedscommons.org/
7	INFO	Disease Consortium Information	https://commons.cri.uchicago.edu/pcdc/
8	INFO	Description	Rhabdomyosarcoma (RMS) Data Dictionary
9	INFO	Total Variables
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11	RowType	VariableName	DataType	Tier	VariableDescription	VariableCode	PermissibleValue	ValueDescription	ValueCode	ImplementationNotes	Mappings	Modeling Notes (ignored in processing)
12
13	DD	Protocol
14	TD	Subject Characteristics
15	TG	One row per subject per study
16	VD	HONEST_BROKER_SUBJECT_ID	String	2 - contributors should prioritize inclusion if resources are available	The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker.	ncit:C168949	_undefined_	_undefined_	_undefined_
17	VD	CONSORTIUM	Enum	2 - contributors should prioritize inclusion if resources are available	The consortium under which this data is being contributed to the Pediatric Cancer Data Commons.	ncit:C61538	_undefined_	_undefined_	_undefined_		New VD
18	PD						INSTRuCT	International Soft Tissue Sarcoma Consortium (INSTRuCT)	ncit:C192758		New PD
19	VD	DATA_CONTRIBUTOR_ID	Enum	2 - contributors should prioritize inclusion if resources are available	An identifier assigned to a data contributor.	ncit:C168950	_undefined_	_undefined_	_undefined_
20	PD						COG	Children's Oncology Group. An NCI-supported clinical cooperative group formed by the merger of the four national pediatric cancer research organizations: the Children's Cancer Group, the Intergroup Rhabdomyosarcoma Study Group, the National Wilms Tumor Study Group, and the Pediatric Oncology Group. The primary objective of the organization is to conduct clinical trials of new therapies for childhood and adolescent cancer. COG develops and coordinates clinical trials conducted at the 238 member institutions that include cancer centers of all major universities and teaching hospitals throughout the U.S. and Canada, as well as sites in Europe and Australia. COG members include over 5000 cancer researchers.	ncit:C39353		New PD
21	PD						EpSSG	European Paediatric Soft Tissue Sarcoma Study Group. An international organization of healthcare professionals devoted to the care and treatment of children and young people with soft tissue sarcoma.	ncit:C192774		New PD
22	PD						CWS	Cooperative Weichteilsarkom Studiengruppe. An international pediatric soft tissue sarcoma study group, also known as the Cooperative Soft Tissue Sarcoma Group, that creates guidance for risk-adapted treatment of soft tissue sarcoma and soft tissue tumors in children, adolescents, and young adults in Europe.	ncit:C192777		New PD
23	PD						MMT	International Society of Paediatric Oncology Malignant Mesenchymal Tumour Committee. An international pediatric oncology committee that specializes in the research of malignant mesenchymal tumors. Along with the Associazione Italiana Ematologia Oncologia Pediatrica-Soft Tissue Sarcoma Committee (AIEOP-STSC), which was formerly known as the Italian Cooperative Group (ICG), SIOP-MMT founded the European pediatric Soft tissue sarcoma Study Group (EpSSG) and the Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) study in 2005 with the goal of making pediatric non-rhabdomyosarcoma soft tissue sarcoma treatment uniform across Europe.	ncit:C192775		New PD
24	PD						STSC	AIEOP Soft Tissue Sarcoma Committee			New PD
25	VD	STUDY_ID	Enum	2 - contributors should prioritize inclusion if resources are available	A sequence of characters used to identify, name, or characterize the study.	ncit:C83082	_undefined_	_undefined_	_undefined_
26	PD						ARST0331	Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma. This non-randomized phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. (ClinicalTrials.gov Identifier: NCT00075582)			New PD
27	PD						ARST0431	Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma. This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma. (ClinicalTrials.gov Identifier: NCT00354744)			New PD
28	PD						ARST0531	Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS). This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. (ClinicalTrials.gov Identifier: NCT00354835)			New PD
29	PD						ARST08P1	A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma. This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. (ClinicalTrials.gov Identifier: NCT01055314)			New PD
30	PD						D9602	Results of the Intergroup Rhabdomyosarcoma Study Group D9602 Protocol, Using Vincristine and Dactinomycin With or Without Cyclophosphamide and Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Embryonal Rhabdomyosarcoma: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group. The objective of this study is to decrease toxicity in similar patients by reducing radiotherapy (RT) doses and eliminating cyclophosphamide for the lowest-risk patients. (Raney RB, Walterhouse DO, Meza JL, et al. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011;29(10):1312-1318. doi:10.1200/JCO.2010.30.4469)			New PD
31	PD						D9802	Rhabdomyosarcoma: Review of the Children’s Oncology Group (COG) Soft-Tissue Sarcoma Committee Experience and Rationale for Current COG Studies. (Malempati S, Hawkins DS. Rhabdomyosarcoma: review of the Children's Oncology Group (COG) Soft-Tissue Sarcoma Committee experience and rationale for current COG studies. Pediatr Blood Cancer. 2012;59(1):5-10. doi:10.1002/pbc.24118)			New PD
32	PD						D9803	Vincristine, Actinomycin, and Cyclophosphamide Compared With Vincristine, Actinomycin, and Cyclophosphamide Alternating With Vincristine, Topotecan, and Cyclophosphamide for Intermediate-Risk Rhabdomyosarcoma: Children's Oncology Group Study D9803. The purpose of this randomized study was to compare the outcome of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with standard VAC (vincristine, dactinomycin, and cyclophosphamide) chemotherapy to that of patients treated with VAC alternating with vincristine, topotecan, and cyclophosphamide (VAC/VTC). (DOI: 10.1200/JCO.2009.22.3768 Journal of Clinical Oncology 27, no. 31 (November 01, 2009) 5182-5188.)			New PD
33	PD						RMS2005	A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005]. This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma. (ClinicalTrials.gov Identifier: NCT00379457)			New PD
34	PD						MTS2008	Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. This study presents the results of the MTS 2008 study with a pooled analysis including patients from the concurrent BERNIE study. (Schoot RA, Chisholm JC, Casanova M, et al. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022;40(32):3730-3740. doi:10.1200/JCO.21.02981)			New PD
35	PD						ICG RMS96	Localized vaginal/uterine rhabdomyosarcoma—results of a pooled analysis from four international cooperative groups. The purpose of this study is to explore the impact of radiation therapy on local failure rate and OS when used as part of primary treatment, and to assess the use of intracavitary brachytherapy between the different cooperative groups. (Minard-Colin V, Walterhouse D, Bisogno G, et al. Localized vaginal/uterine rhabdomyosarcoma-results of a pooled analysis from four international cooperative groups. Pediatr Blood Cancer. 2018;65(9):e27096. doi:10.1002/pbc.27096)			New PD
36	PD						RMS 4.99	Sequential high-dose chemotherapy for children with metastatic rhabdomyosarcoma. The RMS4.99 study was designed to explore the role of multiple sequential high-dose chemotherapy cycles administered early in the treatment of children with metastatic rhabdomyosarcoma. (Bisogno, Gianni & Ferrari, Andrea & Prete, Arcangelo & Messina, Chiara & Basso, Eleonora & Cecchetto, Giovanni & Indolfi, Paolo & Scarzello, Giovanni & D'Angelo, Paolo & De Sio, Luigi & Di Cataldo, Andrea & Carli, Modesto. (2009). Sequential high-dose chemotherapy for children with metastatic rhabdomyosarcoma. European journal of cancer (Oxford, England : 1990). 45. 3035-41. 10.1016/j.ejca.2009.08.019)			New PD
37	PD						CWS-IV-2002	Pediatric Patients with Stage IV Rhabdomyosarcoma Significantly Benefit from Long-Term Maintenance Therapy: Results of the CWS-IV 2002 and the CWS DOK IV 2004-Trials. Report prognostic factors and outcome of patients receiving multimodal treatment for RMS followed by either LTMT, HDCT, or alloHSCT. In addition, we compared the prognosis of patients who received either O-TIE or CYC/VBL as LTMT. The treatment decisions are based on the choice of the treating attending physicians. (Tramsen L, Bochennek K, Sparber-Sauer M, et al. Pediatric Patients with Stage IV Rhabdomyosarcoma Significantly Benefit from Long-Term Maintenance Therapy: Results of the CWS-IV 2002 and the CWS DOK IV 2004-Trials. Cancers (Basel). 2023;15(7):2050. Published 2023 Mar 30. doi:10.3390/cancers15072050)			New PD
38	PD						CWS2002P	Long-Term Clinical Outcome and Prognostic Factors of Children and Adolescents with Localized Rhabdomyosarcoma Treated on the CWS-2002P Protocol. This trial reports the results of the prospective, non-randomized, historically controlled CWS-2002P study in patients ≤ 21 years with localized RMS developed with the aim to improve the long-term outcome by adapting the burden of therapy to risk profile and to investigate the feasibility and relation to the outcome of maintenance therapy (MT) in the high-risk groups. (Koscielniak E, Blank B, Vokuhl C, et al. Long-Term Clinical Outcome and Prognostic Factors of Children and Adolescents with Localized Rhabdomyosarcoma Treated on the CWS-2002P Protocol. Cancers (Basel). 2022;14(4):899. Published 2022 Feb 11. doi:10.3390/cancers14040899)			New PD
39	PD						CWS91	Cooperative trial CWS-91 for localized soft tissue sarcoma in children, adolescents, and young adults. The purpose of this trial is to improve risk-adapted therapy for localized childhood soft tissue sarcoma within an international multicenter setting. (Dantonello TM, Int-Veen C, Harms D, et al. Cooperative trial CWS-91 for localized soft tissue sarcoma in children, adolescents, and young adults. J Clin Oncol. 2009;27(9):1446-1455. doi:10.1200/JCO.2007.15.0466)			New PD
40	PD						CWS96	Treatment of children with metastatic soft tissue sarcoma with oral maintenance compared to high dose chemotherapy: report of the HD CWS-96 trial. This trial studies the efficacy of high dose therapy (HDT) versus an oral maintenance treatment (OMT) in patients with stage IV soft tissue sarcoma (STS). (Klingebiel T, Boos J, Beske F, et al. Treatment of children with metastatic soft tissue sarcoma with oral maintenance compared to high dose chemotherapy: report of the HD CWS-96 trial. Pediatr Blood Cancer. 2008;50(4):739-745. doi:10.1002/pbc.21494)			New PD
41	PD						MMT95	MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood. This randomized phase III trial is studying surgery followed by different regimens of combination chemotherapy given together with radiation therapy and/or additional surgery to compare how well they work in treating patients with soft tissue sarcoma. (ClinicalTrials.gov Identifier: NCT00002898)			New PD
42	VD	EFS_CENSOR_STATUS	Enum	2 - contributors should prioritize inclusion if resources are available	The status of individuals in a study when their outcome (event occurrence or time to event) is censored or not censored at the time of analysis or data collection. Censoring occurs when an individual has not experienced the event of interest by the end of the study period or at the time of data analysis, often because they were lost to follow-up, withdrew from the study, or the study ended before the event could occur. In event-free survival analysis, these censored individuals are included in the analysis up to the point of censoring and are essential for estimating survival probabilities and analyzing the time to events.		_undefined_	_undefined_	_undefined_		skos:exactMatch [RMS].[v2.0].[Subject Characteristics].[CENSOR_STATUS]
43	PD						Censored	The status of a participant or subject in a study whose event or outcome of interest has not yet occurred or has not been observed within the study's follow-up period. Censoring occurs when the event of interest has not happened to a participant by the end of the study or when they are lost to follow-up before the event occurs.	ncit:C118962		skos:exactMatch [RMS].[v2.0].[Subject Characteristics].[Subject is censored (i.e. has had no events(s)]
44	PD						Not Censored	The patient has experienced the event of interest within the study period and has reached the endpoint being evaluated, such as disease progression, relapse, recurrence, or death, and their time to event can be accurately recorded and analyzed.			skos:exactMatch [RMS].[v2.0].[Subject Characteristics].[Subject has had one or more events]
45	PD						Unknown	Reported as unknown by the data contributor.	ncit:C17998		skos:exactMatch [RMS].[v2.0].[Subject Characteristics].[CENSOR_STATUS].[Unknown]
46	VD	TREATMENT_ARM	Enum	2 - contributors should prioritize inclusion if resources are available	A specific treatment plan within a clinical trial that describes the activities a subject will be involved in as he or she progresses through the study.	ncit:C15538	_undefined_	_undefined_	_undefined_
47	PD						ARST0331:Regimen I	Patients received treatment in the following course sequence: 1) VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 1; 2) VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); 3) Radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose.			New PD
48	PD						ARST0331:Regimen II	Patients received treatment in the following course sequence: 1) VAC chemotherapy and radiation therapy as in regimen I; 2) VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy).			New PD
49	PD						ARST0431:High Risk Rhabdomyosarcoma	Patients received treatment in the following course sequence: 1) Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20; 2) Weeks 1-6: vincristine sulfate and irinotecan hydrochloride; 3) Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA; 4) Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim; 5) Radiation therapy beginning at Week 20; 6) Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.			New PD
50	PD						ARST0531:Arm I (Chemotherapy, Radiotherapy)	Patients randomized with the following course sequence: 1) VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; 2) Dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; 3) Cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40; 4) Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.			New PD
51	PD						ARST0531:Arm II (Chemotherapy, Radiotherapy)	Patients randomized with the following course sequence: 1) VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; 2) Dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; 3) Cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; 4) Irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37; 5) Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.			New PD
52	PD						ARST08P1:Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	Patients randomized with the following course sequence: 1) Vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; 2) Irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; 3) Ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, and 30; 4) Doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28, and 32; 5) Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and 44; 6) Dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41, and 44; 7) Cixutumumab IV over 1 hour on day 1 of weeks 1-51; 8) Patients also undergo radiation therapy on days 1-5 of weeks 20-24.			New PD
53	PD						D9602:Subgroup A	Patients received treatment in the following course sequence: 1) Vincristine plus dactinomycin (VA).			New PD
54	PD						D9602:Subgroup B	Patients received treatment in the following course sequence: 1) Vincristine (VA) plus cyclophosphamide.			New PD
55	PD						D9802	Patients randomized with the following course sequence: 1) Bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles; 2) Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment.			New PD
56	PD						D9803	Patients randomized with the following course sequence: 1) Bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles; 2) Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment.			New PD
57	PD						RMS2005	Patients randomized with the following course sequence: 1) 9 cycles of IVA +/− doxorubicin, surgery, and/or radiotherapy.			New PD
58	PD						MTS2008	Patients received treatment in the following course sequence: 1) Four cycles of ifosfamide, vincristine, and actinomycin D (IVA) plus doxorubicin, five cycles of IVA, and 12 cycles of maintenance chemotherapy (low-dose cyclophosphamide and vinorelbine).			New PD
59	PD						ICG RMS96	Patients received treatment in the following course sequence: 1) Radiation therapy (RT)			New PD
60	PD						RMS 4.99	Patients received treatment in the following course sequence: 1) Three cycles of initial standard chemotherapy; 2) One course of cyclophosphamide and etoposide to obtain peripheral blood stem cells (PBSC); 3) Three consecutive high-dose combinations followed by PBSC rescue; 4) Surgery and/or radiotherapy, after which a final maintenance treatment with six courses of vincristine, actinomycin D and cyclophosp.hamide was administered			New PD
61	PD						CWS-IV-2002	Patients received treatment in the following course sequence: 1) Two courses of topotecan and carboplatin; 2) Two consecutive cycles of ifosfamide, vincristine, actinomycin D (I3VA), ifosfamide, vincristine, adriamycin (I3VAd), and TC			New PD
62	PD						CWS2002P:LR	Patients received treatment in the following course sequence: 1) Vincristine (VCR), dactinomycin (ACTO-D)			New PD
63	PD						CWS2002P:SR	Patients received treatment in the following course sequence: 1) Vincristine (VCR), dactinomycin (ACTO-D) and ifosfamide (IFO)			New PD
64	PD						CWS2002P:HR	Patients received treatment in the following course sequence: 1) Vincristine (VCR), dactinomycin (ACTO-D), ifosfamide (IFO) and doxorubicin; 2) Low-dose cyclophosphamide and vinblastine maintenance therapy (MT) over 6 months.			New PD
65	PD						CWS2002P:VHR	Patients received treatment in the following course sequence: 1) Vincristine (VCR), dactinomycin (ACTO-D), ifosfamide (IFO) and doxorubicin; 2) Low-dose cyclophosphamide and vinblastine maintenance therapy (MT) over 6 months.			New PD
66	PD						CWS91	Patients received treatment in the following course sequence: 1) Etoposide, vincristine, dactinomycin, ifosfamide, and doxorubicin (EVAIA)			New PD
67	PD						CWS96:High Dose Therapy (HDT)	Patients received treatment in the following course sequence: 1) Carboplatin, etoposide, vincristine, actinomycin D, ifosfamide, and epirubicin; 2) Cycle of thiotepa (600 mg/m2) plus cyclophosphamide (4,500 mg/m2) and melphalan (120 mg/m2) plus etoposide (1,800 mg/m2)			New PD
68	PD						CWS96:Oral Maintenance Therapy (OMT)	Patients received treatment in the following course sequence: 1) Carboplatin, etoposide, vincristine, actinomycin D, ifosfamide, and epirubicin; 2) Four cycles trofosfamide (10 days 2 × 75 mg/m2/day) plus etoposide (10 days 2 × 25 mg/m2/day), and 4 cycles trofosfamide (10 days 2 × 75 mg/m2/day) plus idarubicin (10 days 4 × 5 mg/m2).			New PD
69	PD						MMT95	Patients randomized with the following course sequence: 1) Ifosfamide, vincristine, and dactinomycin (IVA) or a six-drug combination (IVA plus carboplatin, epirubicin, and etoposide) both delivered over 27 weeks.			New PD
70
71
72	DD	Protocol
73	TD	Time Period									skos:broadMatch [RMS].[v2.0].[Disease Phase Timing] \|\| skos:broadMatch [RMS].[v2.0].[Course Timing]
74	TG	One row per subject per time period type
75	VD	HONEST_BROKER_SUBJECT_ID	String	2 - contributors should prioritize inclusion if resources are available	The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker.	ncit:C168949	_undefined_	_undefined_	_undefined_
76	VD	SUBMITTER_ID	String	2 - contributors should prioritize inclusion if resources are available	An ID provided by the data contributor that identifies a unique time period and that is referenced throughout subsequent tabels in the TIME_PERIOD_SUBMITTER_ID variables.		_undefined_	_undefined_	_undefined_		New VD
77	VD	PARENT_SUBMITTER_ID	String	2 - contributors should prioritize inclusion if resources are available	The SUBMITTER_ID of the time period in whose context a subsequent time period takes place. For example, multiple treatment courses occuring the "Initial Diagnosis" period would each reference the SUBMITTER_ID of the "Initial Diagnosis" period as their PARENT_SUBMITTER_ID.		_undefined_	_undefined_	_undefined_		New VD
78	VD	TIME_PERIOD_TYPE	Enum	2 - contributors should prioritize inclusion if resources are available	The type of time period being reported.		_undefined_	_undefined_	_undefined_		New VD
79	PD						Disease Phase	The stage or period of an individual's disease.	ncit:C168878		New PD
80	PD						Course	The type of protocol treatment course administered with respect to Course Timing.	ncit:C187095		New PD
81	VD	DISEASE_PHASE	Enum	2 - contributors should prioritize inclusion if resources are available	The phase of the cancer treatment process during which relevant observations were recorded. This variable is used across domains to frame the timing of these longitudinal observations and reduce the number of redundant variables needed to report similar concepts (see "Disease Phase Timing and Course Table" in the documentation for additional guidance).	ncit:C168878	_undefined_	_undefined_	_undefined_		skos:exactMatch [RMS].[v2.0].[Disease Phase Timing].[DISEASE_PHASE]
82	PD						Initial Diagnosis	The first diagnosis of the individual's condition.	ncit:C156813		skos:exactMatch [RMS].[v2.0].[Disease Phase Timing].[DISEASE_PHASE].[Initial Diagnosis]
83	PD						Relapse	The return of a disease after a period of remission.	ncit:C38155		skos:exactMatch [RMS].[v2.0].[Disease Phase Timing].[DISEASE_PHASE].[Relapse]
84	PD						Progression	A process that manifests as the worsening of a disease over time.	ncit:C17747		skos:exactMatch [RMS].[v2.0].[Disease Phase Timing].[DISEASE_PHASE].[Progression]
85	VD	COURSE	Enum	2 - contributors should prioritize inclusion if resources are available	The protocol treatment "course" during which relevant observations were recorded. This variable is used across domains to frame the timing of these longitudinal observations and reduce the number of redundant variables needed to report similar concepts (see "Disease Phase Timing and Course Table" in the documentation for additional guidance).	ncit:C168807	_undefined_	_undefined_	_undefined_		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE]
86	PD						Prephase	A chemotherapy treatment administered prior to the definitive chemotherapy treatment.	ncit:C168826		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE].[Prephase]
87	PD						Induction	The first choice of treatment for a particular type of cancer.	ncit:C158876		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE].[Induction]
88	PD						Intensification	A second round of intense chemotherapy as part of consolidation therapy.	ncit:C173105		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE].[Intensification]
89	PD						Consolidation	Treatment that is given after initial therapy to kill any remaining cancer cells.	ncit:C15679		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE].[Consolidation]
90	PD						Maintenance	Continuation of treatment for an extended period of time to prevent relapse.	ncit:C15688		skos:exactMatch [RMS].[v2.0].[Course Timing].[COURSE].[Maintenance]
91	VD	TIME_PERIOD_NUMBER	Integer	2 - contributors should prioritize inclusion if resources are available	This variable indicates the ordinal numbering of time periods of the same TIME_PERIOD_TYPE within its various subgroups (e.g., Relapse 1, Relapse 2, Relapse 3, etc.). The observations across domains can therefore be organized longitudinally without the need for specific dates.		_undefined_	_undefined_	_undefined_		skos:broadMatch [RMS].[v2.0].[Disease Phase Timing].[DISEASE_PHASE_NUMBER] \|\| skos:broadMatch [RMS].[v2.0].[Course Timing].[COURSE_NUMBER]
92	VD	YEAR_AT_START	Integer	2 - contributors should prioritize inclusion if resources are available	The year at the start of the indicated time period.		_undefined_	_undefined_	_undefined_		skos:exactMatch [RMS].[v2.0].[Disease Phase Timing].[YEAR_AT_DISEASE_PHASE]
93	VD	AGE_AT_START	Integer	2 - contributors should prioritize inclusion if resources are available	The age (in days) of the patient at the start of the reported time period.		_undefined_	_undefined_	_undefined_		skos:broadMatch [RMS].[v2.0].[Disease Phase Timing].[AGE_AT_DISEASE_PHASE] \|\| skos:broadMatch [RMS].[v2.0].[Course Timing].[AGE_AT_COURSE_START]
94	VD	AGE_AT_END	Integer	2 - contributors should prioritize inclusion if resources are available	The age (in days) of the patient at the end of the reported time period.		_undefined_	_undefined_	_undefined_		skos:broadMatch [RMS].[v2.0].[Course Timing].[AGE_AT_COURSE_END]
95
96
97	DD	Demographics
98	TD	Demographics
99	TG	One row per subject
100	VD	HONEST_BROKER_SUBJECT_ID	String	2 - contributors should prioritize inclusion if resources are available	The identifier assigned to the subject by the honest broker. An individual, organization or system acting for, or on behalf of, a covered entity to collect and provide health information to research investigators in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients-subjects directly or indirectly. The honest broker cannot be one of the investigators. The information provided to the investigators by the honest broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a "re-identification code"), however the information linking this re- identification code to the patient's identity must be retained by the honest broker and subsequent inquiries are conducted through the honest broker.	ncit:C168949	_undefined_	_undefined_	_undefined_