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ACUTE LYMPHOBLASTIC LEUKEMIA, previously untreated - PRESTUDY FORM

- 02.08.17 - 1 Formular, 4 Itemgruppen, 34 Datenelemente, 1 Sprache

Itemgruppen: Disease Description, Organ Involvement, LABORATORY VALUES, CCRR MODULE

S0100 PREVIOUSLY UNTREATED ACUTE LYMPHOBLASTIC LEUKEMIA PRESTUDY FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEB40E5C-A386-418C-E034-0003BA12F5E7

Lung Cancer NCT00946712 Pre-Study - Southwest Oncology Group S0819 Prestudy Form - 2863901v1.0 - Southwest Oncology Group S0819 Prestudy Form

- 20.09.21 - 1 Formular, 8 Itemgruppen, 72 Datenelemente, 1 Sprache

Itemgruppen: Header Module, PATIENT AND DISEASE DESCRIPTION, PATIENT AND DISEASE DESCRIPTION1, LABORATORY VALUES, LABORATORY VALUES1, ADDITIONAL PRESTUDY DATA, PRIOR TREATMENT RELATED TO THIS CANCER, Comments

Southwest Oncology Group S0819 Prestudy Form Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=684FE956-5AAF-A7DA-E040-BB89AD432A2B

Lung Cancer NCT00863512 Pre-Study - CALGB 30506 Pre-Study/Surgical Resection Form - 2821782v1.0 - CALGB 30506 Pre-Study/Surgical Resection Form

- 20.09.21 - 1 Formular, 9 Itemgruppen, 46 Datenelemente, 1 Sprache

Itemgruppen: Header Module, Header, Initial Laboratory Values, Smoking Status, Pre-surgical Disease Status, Surgical Disease Status, Planned Treatment, Contact Information, Footer Module

CALGB 30506 Pre-Study/Surgical Resection Form Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5FE8C8A3-6705-BC07-E040-BB89AD4332A8

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Laboratory Tests Data

- 14.11.18 - 1 Formular, 6 Itemgruppen, 23 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Timepoint, Hematology, Chemistry / Serum HCG / SP Chemistry, UA / UDS / Urine Chemistry, Serology

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Southwest Oncology Group Medical Conditions Questionnaire

- 03.07.15 - 1 Formular, 3 Itemgruppen, 36 Datenelemente, 1 Sprache

Itemgruppen: SWOG clinical trial administrative data, Medical Conditions, CCRR MODULE

Southwest Oncology Group Medical Conditions Questionnaire Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A4CF6FCD-888E-36E1-E034-080020C9C0E0

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Prior Concomitant Medications and Non-Drug Therapies

- 14.11.18 - 1 Formular, 3 Itemgruppen, 20 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Prior Medications and Therapies, If Yes, add details on next page (includes over-the counter and prescription drugs) below

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Prestudy form NSCLC Stage III NCT00020709

- 20.09.21 - 1 Formular, 4 Itemgruppen, 25 Datenelemente, 1 Sprache

Itemgruppen: SWOG clinical trial administrative data, PATIENT AND DISEASE DESCRIPTION, CURRENT LABORATORY VALUES (SI UNITS), Notes

NCT00020709 S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CA62D43-4AA8-361C-E034-080020C9C0E0

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: General Medical History

- 14.11.18 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Relevant Medical Conditions

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Electrocardiogram

- 14.11.18 - 1 Formular, 3 Itemgruppen, 21 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, ECG, Interpretation of ECG

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Physical Examination

- 14.11.18 - 1 Formular, 2 Itemgruppen, 29 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Physical Examination

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: Inclusion Criteria

- 05.12.18 - 1 Formular, 3 Itemgruppen, 5 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Eligibility check, Inclusion Criteria

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: Exclusion Criteria

- 05.12.18 - 1 Formular, 3 Itemgruppen, 21 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Eligibility check, Exclusion Criteria

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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