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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)

- 4/1/22 - 1 form, 6 itemgroups, 37 items, 1 language

Itemgroups: Date of physical examination,B- Symptoms,Physical Examination,Organ/ System,Hematology,Chemistry

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 7 (Visit 6)

- 2/18/22 - 1 form, 6 itemgroups, 38 items, 1 language

Itemgroups: Date of physical examination,B- Symptoms,Physical Examination,Organ/ System,Hematology,Chemistry

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Follow- Up

- 1/31/22 - 1 form, 8 itemgroups, 44 items, 1 language

Itemgroups: Date of physical examination,Visit Week physical examination,B- Symptoms,Physical Examination,Organ/ System,Visit Week laboratory,Hematology,Chemistry

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

- 9/20/21 - 1 form, 11 itemgroups, 99 items, 1 language

Itemgroups: Administrative,Medical Examination,Medical consultation,laboratory tests,Aftercare,medical consultation early cancer prevention,vaccination status,cardiovascular risk factor,Rehabilitation measures,Physical therapy,Medication

Study part: Present aftercare Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response

- 4/1/21 - 1 form, 16 itemgroups, 59 items, 1 language

Itemgroups: Administrative,Physical Examination (Follow-Up),Physical Examination (Follow-Up),Laboratory Results - Hematology/ Chemistry (Follow-Up),Laboratory Results (Follow-Up) - Hematology,Laboratory Results (Follow-Up) - Hematology,Laboratory Results (Follow-Up) - Chemistry,Laboratory Results (Follow-Up) - Chemistry,Post-Treatment Response (Follow -Up),Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results,Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy,Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease,Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease,Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease,Post-Treatment Response (Follow-Up) - Response,Signature of Investigator

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Physical Examination

- 2/19/21 - 1 form, 3 itemgroups, 12 items, 1 language

Itemgroups: Administrative Data,Physical Lymph Node Examination,Physical Organ Exam

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit, the first and last weekly visits during the cycles of therapy, the cycle observation visits, unscheduled visits, withdrawal visits and the visits at the end of study/treatment.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Post-Treatment Physical Exam

- 9/3/20 - 1 form, 3 itemgroups, 46 items, 1 language

Itemgroups: Administrative Data,Vital Signs,Pre-treatment physical exam

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Post-Treatment Physical Exam Form is used to record the physical examination prior to initiation of treatment. For patients receiving Argatroban for no more than 14 days, complete within 24 hours of final infusion completion. For patients receiving Argatroban for more than 14 days [continuing with non-study Argatroban], complete within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Pre-Treatment Physical Exam

- 9/3/20 - 1 form, 3 itemgroups, 46 items, 1 language

Itemgroups: Administrative Data,Vital Signs,Pre-treatment physical exam

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Pre-Treatment Physical Exam Form has to be filled in at the screening visit. It is used to record the physical examination prior to initiation of treatment. To be completed within 72 hours before treatment initiation.

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 10/30/19 - 1 form, 19 itemgroups, 82 items, 1 language

Itemgroups: Administrative,Visit Date,Was a physical examination performed?,Physical Examination,Vital Signs,12-Lead ECG,ECG Results,ECG Findings,Hematology,Hematology ,Clinical Chemistry, Coagulation and Electrolytes,Clinical Chemistry, Coagulation and Electrolytes ,Urinalysis dipstick results,Urinalysis microscopy results,Urinalysis microscopy results ,Serum beta-hCG Pregnancy Test,PK Sampling - Plasma Samples,Study Treatment Compliance (Return) ,New Adverse Events and Concomitant Treatment

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501, Monotherapy, Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/10/19 - 1 form, 23 itemgroups, 109 items, 1 language

Itemgroups: Administrative,Visit Date,Was a physical examination performed?,Physical Examination,Vital Signs,12-Lead ECG,ECG Result,ECG Findings,Hematology,Hematology ,Clinical Chemistry, Coagulation and Electrolytes,Clinical Chemistry, Coagulation and Electrolytes ,Urinalysis dipstick results,Urinalysis microscopy results,Urinalysis microscopy results ,Serum beta-hCG Pregnancy Test,Radiographic Assessment,Radiographic Assessment ,Disease Marker Assessment ,Disease Marker Assessment ,Disease Response,Study Treatment Compliance (Return) ,New Adverse Events and Concomitant Treatment

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501 + Bortezomib Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/10/19 - 1 form, 23 itemgroups, 107 items, 1 language

Itemgroups: Administrative,Visit Date,Was a physical examination performed?,Physical Examination,Vital Signs,12-Lead ECG,ECG Result,ECG Findings,Hematology,Hematology ,Clinical Chemistry, Coagulation and Electrolytes,Clinical Chemistry, Coagulation and Electrolytes ,Urinalysis dipstick results,Urinalysis microscopy results,Urinalysis microscopy results ,Serum beta-hCG Pregnancy Test,Radiographic Assessment,Radiographic Assessment ,Disease Marker Assessment ,Disease Marker Assessment ,Disease Response,Study Treatment Compliance (Return) ,New Adverse Events and Concomitant Treatment

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Screening Visit

- 3/6/19 - 1 form, 17 itemgroups, 137 items, 1 language

Itemgroups: ELIMINATION CRITERIA DURING THE STUDY,CONTRAINDICATIONS TO SUBSEQUENT VACCINATION,INFORMED CONSENT,DEMOGRAPHICS,ELIGIBILITY CHECK,INCLUSION CRITERIA,EXCLUSION CRITERIA,GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION,VITAL SIGNS,HEMATOLOGY / BIOCHEMISTRY,HEMATOLOGY,BIOCHEMISTRY,LDH,URINALYSIS,Urinalysis (Dipstick) Test,SCREENING CONCLUSION,INVESTIGATOR'S SIGNATURE

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 13 (Visit 8)

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Week 7 (Visit 6)

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Follow- Up

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Physical Examination

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Post-Treatment Physical Exam

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Pre-Treatment Physical Exam

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Screening Visit

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