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Eligibility Acute Lymphoblastic Leukemia NCT00165087

- 08.12.15 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Treatment of Childhood Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00165087

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - Concomitant Medication

- 19.11.18 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Concomitant Medication, Medication Data
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form asks for concomitant medications of the subject. It should be filled out at first visit, and re-checked at each subsequent visit.

Maintenance therapy R2 AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Maintenance therapy R2 AIEOP-BFM ALL 2009 NCT01117441

- 15.03.21 - 1 Formular, 3 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Examinations, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

Laboratory Parameters R-R2 AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Laboratory Parameters R-R2 AIEOP-BFM ALL 2009 NCT01117441

- 15.05.16 - 1 Formular, 4 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Laboratory Parameters Study Section, Laboratory Parameters Control Section, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Laboratory documentation. Clinical Trial Number: NCT01117441.

Laboratory Parameters R-HR AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Laboratory Parameters R-HR AIEOP-BFM ALL 2009 NCT01117441

- 15.05.16 - 1 Formular, 4 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Laboratory Parameters Study Section, Laboratory Parameters Control Section, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Laboratory documentation. Clinical Trial Number: NCT01117441.

Initial survey AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Initial survey AIEOP-BFM ALL 2009 NCT01117441

- 15.05.16 - 1 Formular, 9 Itemgruppen, 103 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Anamnesis, Diagnosis, Blood analysis, Initial CNS status, Multi-organ involvement, Prednisone response, Comments, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Initial survey. Please send this document within one month after diagnosis to the study centre. Clinical Trial Number: NCT01117441.

Event recording AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Event recording AIEOP-BFM ALL 2009 NCT01117441

- 09.05.16 - 1 Formular, 7 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Relapse, Second neoplasms, Death, Therapy discontinuation, Comments, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Event Recording. All events have to be reported to the study centre within two weeks after event. Clinical Trial Number: NCT01117441.

Protocol medication AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Protocol medication AIEOP-BFM ALL 2009 NCT01117441

- 14.07.16 - 1 Formular, 14 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, First Element, Second Element, Third Element, Fourth Element, Fifth Element, Sixth Element, Seventh Element, Eighth Element, Ninth Element, Cranial radiation, Maintenance treatment, Comments, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation of administered protocol medication Clinical Trial Number: NCT01117441.

Documentation of therapy toxicity AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Documentation of therapy toxicity AIEOP-BFM ALL 2009 NCT01117441

- 31.05.16 - 1 Formular, 6 Itemgruppen, 25 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Therapy, Blood analysis, Toxicity, Comments, Identification and Signature
Study Description Stamm: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation of therapy toxicity. Clinical Trial Number: NCT01117441.

HR-3 therapy documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - HR-3 therapy documentation AIEOP-BFM ALL 2009 NCT01117441

- 09.05.16 - 1 Formular, 4 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Chemotherapy Regimen, PEG-L-ASP/ Erwinase, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

HR-2 therapy documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - HR-2 therapy documentation AIEOP-BFM ALL 2009 NCT01117441

- 09.05.16 - 1 Formular, 4 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Chemotherapy Regimen, PEG-L-ASP/ Erwinase, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

DNX-FLA regimen AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - DNX-FLA regimen AIEOP-BFM ALL 2009 NCT01117441

- 09.05.16 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Chemotherapy Regimen, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

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