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Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 Formular, 16 Itemgruppen, 104 Datenelemente, 1 Sprache
Itemgruppen: Medical and Surgical History, Significant Medical and Surgical History, NSCLC Diagnosis, NSCLC-related Surgery, Tobacco/Nicotine History at Randomization, Prior Adjuvant Chemotherapy, Prior Adjuvant Chemotherapy for NSCLC, Optional Research Blood Sample, Radiology, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Study Drug Dispensed, Investigator's Signature
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Baseline Assessments

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 Formular, 10 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: On-Treatment Assessments

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 Formular, 11 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed Applicable, Study Drug Dispensed
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Unscheduled Visit

Post-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Post-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 Formular, 7 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Vital Assessment, Physical Examination, Pregnancy Test, Biochemistry/Proteomics, Off Treatment Reason, Death, Investigator Signature
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Post-Treatment Assessments

Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 Formular, 8 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Open-label Tarceva Dispensed
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Open-label Baseline Assessments

REFLECT-1 Visit 9 NCT00428090

- 9/25/16 - 1 Formular, 15 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Central Laboratory Instructions, Investigator Instructions, Vital signs, Neurologic Examination, Central Laboratory, Pregnancy Test, 12-Lead ECG, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Rating Scale Instrucitions, Investigational Product Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 3 NCT00428090

- 9/25/16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 2 NCT00428090

- 9/25/16 - 1 Formular, 10 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 5 NCT00428090

- 9/25/16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 4 NCT00428090

- 9/25/16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 7 NCT00428090

- 9/25/16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

REFLECT-1 Visit 8 NCT00428090

- 9/25/16 - 1 Formular, 12 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient Information, Investigator Instructions, Subject Continuation, Vital signs, Central Laboratory, Concomitant medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product, Compliance, End of Visit Reminder
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

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