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PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 08.06.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 08.06.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 08.06.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 08.06.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Dose 2 (Primary)

- 10.01.19 - 1 Formular, 18 Itemgruppen, 79 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dose 2 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Other Local Symptoms, Dose 2 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 2 - Other General Symptoms, Dose 2 - Medication, Reminder
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Booster Dose (Local and General Symptoms)

- 10.01.19 - 1 Formular, 18 Itemgruppen, 78 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Booster Dose - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Booster Dose - Other Local Symptoms, Booster Dose - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Booster Dose - Other General Symptoms, Booster Dose - Medication, Reminder
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK study: Ropinirole in RLS patients 101468/243 - Patient Rating Scales Baseline, Week 12, 24, 36, 48 and EW

- 30.07.17 - 1 Formular, 6 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Patient rated scale baseline, Patient rated scale week 12, Patient rated scale week 24, Patient rated scale week 36, Patient rated scale week 48, Patient rated scale early withdrawal
GSK study: Ropinirole in RLS patients 101468/243 - Patient Rating Scales Baseline, Week 12, 24, 36, 48 and EW Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1

- 30.07.17 - 1 Formular, 22 Itemgruppen, 49 Datenelemente, 1 Sprache
Itemgruppen: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Laboratory test, Urine dipstick, Pregnancy dipstick, Clinical global impression, Pregnancy information, Study conclusion, investigator signature
ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Week 36

- 30.07.17 - 1 Formular, 30 Itemgruppen, 78 Datenelemente, 1 Sprache
Itemgruppen: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Clinical global impression, Instructions for the investigator, Clinical Global impression, Dose modification, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study Subject Participation Status, investigator signature
Module 9A: Wk 36 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Week 48

- 30.07.17 - 1 Formular, 30 Itemgruppen, 78 Datenelemente, 1 Sprache
Itemgruppen: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Clinical global impression, Instructions for the investigator, Clinical Global impression, Dose modification, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study Subject Participation Status, investigator signature
Module 9B: Wk 36 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Week 24

- 29.07.17 - 1 Formular, 33 Itemgruppen, 84 Datenelemente, 1 Sprache
Itemgruppen: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Laboratory test, Urine dipstick, Pregnancy dipstick, Clinical global impression, Instructions for the investigator, Clinical Global impression, Dose modification, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study Subject Participation Status, investigator signature
Module 6B: Wk 24 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

GSK study: Ropinirole in RLS patients 101468/243 - Week 12

- 29.07.17 - 1 Formular, 30 Itemgruppen, 78 Datenelemente, 1 Sprache
Itemgruppen: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Clinical global impression, Instructions for the investigator, Clinical Global impression, Dose modification, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study Subject Participation Status, investigator signature
Module 6A: Wk 12 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

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