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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
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CALGB: 10603 Follow-Up Form DRKS00003845 NCT00651261 - CALGB: 10603 Follow-Up Form NCT00651261

- 08/06/2015 - 1 modulo, 10 itemgroups, 51 elementi, 1 linguaggio
Itemgroups: Header, Patient demographics, Treatment Phase Information, Vital Status, Disease Follow-Up Status, Notice of Progression, RECOVERY, Transplant Treatment Plan, Notice of New Primary Cancer, Footer Module
CALGB: 10603 Follow-Up Form NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43C5D677-EB7A-6D45-E044-0003BA3F9857

LA1

- 08/06/2015 - 1 modulo, 13 itemgroups, 24 elementi, 1 linguaggio
Itemgroups: Header module, Laboratory assessments, CBC, Hematocrit, Hemoglobin, WBC, Neutrophils, Lymphocytes, Chemistry and LFT's, Creatinine, Bilirubin, AST, ALT
LA1 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1A902D-29B1-3DEE-E034-0003BA3F9857

E1900 Induction Treatment Form NCT00049517

- 03/06/2015 - 1 modulo, 5 itemgroups, 30 elementi, 1 linguaggio
Itemgroups: ECOG clinical trial administrative data, Vital Status, Treatment Cycle Information, Comments, CCRR MODULE
E1900 Induction Treatment Form NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294EC6-E15C-2FD0-E034-0003BA0B1A09

E1900 Toxicity Form NCT00049517

- 03/06/2015 - 1 modulo, 4 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: ECOG clinical trial administrative data, Adverse event assessment, Comments, CCRR MODULE
E1900 Toxicity Form NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294BEF-41E2-2FCE-E034-0003BA0B1A09

Treatment Form - Autologous Transplant NCT00049517

- 03/06/2015 - 1 modulo, 10 itemgroups, 32 elementi, 1 linguaggio
Itemgroups: ECOG clinical trial administrative data, Vital Status, High Dose Cytarabine Consolidation Therapy, Peripheral Bood Stem Cell Harvest, Gemtuzumab-ozogamicin Consolidation Therapy, Transplant Conditioning Regimen, PBSC Reinfusion, Transfusions, Comments, CCRR MODULE
Treatment Form - Autologous Transplant NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A727E609-20CC-2F84-E034-0003BA0B1A09

E1900 Non-Protocol Therapy Form NCT00049517

- 03/06/2015 - 1 modulo, 4 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: ECOG clinical trial administrative data, Non-protocol therapy, Comments, CCRR MODULE
E1900 Non-Protocol Therapy Form NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7293E99-DB96-2FBE-E034-0003BA0B1A09

E1900 Second Primary Form NCT00049517

- 03/06/2015 - 1 modulo, 4 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: ECOG clinical trial administrative data, Diagnosis Second Primary Cancer, Comments, CCRR MODULE
E1900 Second Primary Form NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A72941B2-95F8-2FC4-E034-0003BA0B1A09

GVH

- 28/05/2015 - 1 modulo, 6 itemgroups, 49 elementi, 1 linguaggio
Itemgroups: Header Module, Record the highest level of organ abnormalities, the etiologies contributing to the abnormalities and any biopsy results pertaining to GVHD during the assessment period, Skin etiologies, Upper intestinal tract etiologies, Lower intestinal tract etiologies, Liver etiologies
GVH Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19F489-B086-2FD8-E034-0003BA3F9857

Re-Admission/Hospitalization Form (ADM)

- 28/05/2015 - 1 modulo, 2 itemgroups, 25 elementi, 1 linguaggio
Itemgroups: Header Module, Record secondary discharge diagnoses
Re-Admission/Hospitalization Form (ADM) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1A99BE-38AD-3F09-E034-0003BA3F9857

DTH

- 28/05/2015 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Patient death, Enter appropriate cause of death code below. List in order of decreasing severity
DTH Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1A2AFC-A449-1B00-E034-0003BA3F9857

INF

- 28/05/2015 - 1 modulo, 5 itemgroups, 25 elementi, 1 linguaggio
Itemgroups: Patient infection medical history, Infection I, Infection II, Infection III, Provide agent(s) administered for this infectious period
INF Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1B2D88-AFFF-3372-E034-0003BA3F9857

CSL

- 28/05/2015 - 1 modulo, 10 itemgroups, 29 elementi, 1 linguaggio
Itemgroups: Header Module, Record date each apheresis was performed, For each selection procedure performed, record the following information, Starting HPC-A product #1, Starting HPC-A product #2, Starting HPC-A product #3, For each column used, record the following information, Pre-selection/post platelet & antibody wash product #1, Pre-selection/post platelet & antibody wash product #2, Pre-selection/post platelet & antibody wash product #3
CSL Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF1A00BE-B650-1746-E034-0003BA3F9857

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