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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 18.11.21 - 9 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Itemgroepen 84 Data-elementen

On-Treatment 2

13 Itemgroepen 62 Data-elementen

On-Treatment 4

12 Itemgroepen 62 Data-elementen

On-Treatment 6

12 Itemgroepen 62 Data-elementen

On-Treatment 7

13 Itemgroepen 67 Data-elementen

On-Treatment 8

13 Itemgroepen 67 Data-elementen

Bogen 2 Verlaufsbogen Seite 1 von 2 TIGER Studie Version 23052012 Condition DRKS00005243 - Bogen 2 Verlaufsbogen Seite 1 von 2

- 20.09.21 - 1 Formulier, 11 Itemgroepen, 39 Data-elementen, 2 Talen
Itemgroepen: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Therapiephase, Bisherige Therapie im Intervall, Nilotinib 2*300 mg, 1. Nilotinib Pause, PEG-IFN, 1. PEG-IFN Pause, weitere Medikation, Unterschrift
NCT01657604

CML TIGER inclusion DRKS00005243 NCT01657604 - Bogen 1 Einschluss Randomisierung CML NCT01657604

- 20.09.21 - 1 Formulier, 16 Itemgroepen, 106 Data-elementen, 2 Talen
Itemgroepen: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Randomisierung, Laborwerte, Molekularbiologie, BCR-ABL-Transkripte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Vor- und Begleiterkrankungen, Medikamente, Knochenmarkanalyse, Zytogenetik, Unterschrift
Bogen 1 Einschluss Randomisierung TIGER Studie Version 22052012 Condition NCT01657604

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment - Previous and current therapies for leukemia

- 20.09.21 - 8 Formulieren, 4 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: PREVIOUS AND CURRENT THERAPIES FOR LEUKEMIA, STEM CELL TRANSPLANT, PRIOR RADIOTHERAPY FOR LEUKEMIA, EXTERNAL DATA TRACKING
Study documentation part: Pre-Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.

Medical tests and examinations

5 Itemgroepen 43 Data-elementen

Pre- treatment status

2 Itemgroepen 10 Data-elementen

Pre- Treatment events

3 Itemgroepen 18 Data-elementen

Previous and current medications

1 Itemgroep 3 Data-elementen

General Medical History

5 Itemgroepen 37 Data-elementen

Imatinib Mesylate

3 Itemgroepen 13 Data-elementen

Bogen 1 Bestehende medizinische Symptome DRKS00005243 NCT01657604 CML - Bogen 1 Bestehende medizinische Symptome

- 20.09.21 - 1 Formulier, 4 Itemgroepen, 25 Data-elementen, 2 Talen
Itemgroepen: Allgemeine Angaben, Symptome, SAE, Kommentar
German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Bogen 2 Adverse events DRKS00005243 NCT01657604 CML - Bogen 2 Adverse events

- 20.09.21 - 1 Formulier, 4 Itemgroepen, 26 Data-elementen, 2 Talen
Itemgroepen: Allgemeine Angaben, Unerwünschte Nebenwirkungen, SAE, Kommentar
German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Bogen 0 Ersterhebung_Diagnose DRKS00005243 NCT01657604 CML - Bogen 0 Ersterhebung_Diagnose

- 20.09.21 - 1 Formulier, 6 Itemgroepen, 88 Data-elementen, 2 Talen
Itemgroepen: Allgemeine Angaben, Laborwerte, Klinischer Befund, Molekularbiologie, Knochenmarkanalyse, Zytogenetik
German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

TIGER Study CML Disease Course DRKS00005243 NCT01657604 - Disease Course TIGER Study CML NCT01657604

- 20.09.21 - 1 Formulier, 12 Itemgroepen, 89 Data-elementen, 2 Talen
Itemgroepen: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Laborwerte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Molekularbiologie, Knochenmarkanalyse, Zytogenetik, Unterschrift
Bogen 2 Verlaufsbogen Seite 2 von 2 NCT01657604

Follow-Up 2/2 CML TIGER DRKS00005243 NCT01657604 - Follow-Up 2/2 CML TIGER NCT01657604

- 20.09.21 - 1 Formulier, 12 Itemgroepen, 89 Data-elementen, 2 Talen
Itemgroepen: Administrative Items, Geburtsdatum, Adiminstrative Daten II, Laborwerte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Molekularbiologie, Knochenmarkanalyse, Cytogenetics, Unterschrift
Bogen 2 Verlaufsbogen Seite 2 von 2 NCT01657604 Chronic Myeloid Leukemia Tasigna and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study http://clinicaltrials.gov/ct2/show/NCT01657604

Molecular Monitoring Survey EUREKA - Case Report Form (CRF)

- 17.09.21 - 1 Formulier, 6 Itemgroepen, 27 Data-elementen, 1 Taal
Itemgroepen: Blood Sample Collection, Physician Information, Patient Information, CML Diagnosis, Treatment, Date & Signature, Addresses of reference laboratories
European survey on the assessment of deep molecular REsponse in chronic phase CML patients after at least two years of therapy with tyrosine KinAse inhibitors - major component of the Path to Cure Pillar of EUTOS III. ODM derived from: http://www.eutos.org/content/path_to_cure/eureka/index_eng.html

Eligibility Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive NCT02130557

- 26.06.20 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02130557

Eligibility Leukemia, Myelogenous, Chronic, BCR-ABL Positive NCT01464411

- 26.06.20 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan; ODM derived from: https://clinicaltrials.gov/show/NCT01464411

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