- 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
- 2/19/21 - 1 form, 3 itemgroups, 12 items, 1 language
Itemgroups: Administrative Data,Physical Lymph Node Examination,Physical Organ 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.
- 9/3/20 - 1 form, 3 itemgroups, 46 items, 1 language
Itemgroups: Administrative Data,Vital Signs,Pre-treatment physical exam
- 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
- 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
- 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

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