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Study completion_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Study completion form

- 27.09.21 - 1 Formular, 5 Itemgruppen, 30 Datenelemente, 1 Sprache

Itemgruppen: Study completion, Hematology, Biochemistry, Withdrawal of demand medication, Assessment

Study part: Study completion form.Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V5 (Day 140 + - 14)

- 27.09.21 - 1 Formular, 8 Itemgruppen, 49 Datenelemente, 1 Sprache

Itemgruppen: Visit, Physical examination, Medical Examination Rhinoscope, Spirometry; Peak Expiratory Flow, Medication, Hematology, Biochemistry, medication Demand

Study part: Visit V5 (Day 140 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Visit V6_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V6 (Day 196 + - 14)

- 27.09.21 - 1 Formular, 5 Itemgruppen, 35 Datenelemente, 1 Sprache

Itemgruppen: Visit, Physical examination, Medical Examination Rhinoscope, Spirometry; Peak Expiratory Flow, medication Demand

Study part: Visit V6 (Day 196 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological/Hypersensitivity Adverse Event Form

- 20.09.21 - 1 Formular, 11 Itemgruppen, 66 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Dermatological/Hypersensitivity Adverse Event, Systemic Symptoms, Signs or Laboratory Abnormalities, Haematologic Abnormalities, Supportive/Investigative Measures, Diagnosis, Responsible for Diagnosis, Lesion Location, Concomitant Medication, Infections, Conclusion

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occur during the study. Record details of any dematological/hypersensitivity adverse event in the appropriate Non-Serious Adverse/Serious Adverse Event section of the CRF. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Hypersensitivity/ Anaphylaxis Evaluation Mepolizumab HES NCT00086658 - Hypersensitivity/ Anaphylaxis Evaluation

- 20.09.21 - 1 Formular, 1 Itemgruppe, 53 Datenelemente, 1 Sprache

Itemgruppe: evaluation Hypersensitivity

Study part: Hypersensitivity/ Anaphylaxis Evaluation.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79 - Visit V0 Screening visit

- 20.09.21 - 1 Formular, 18 Itemgruppen, 157 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria, demographics, Laboratory, Physical examination, Medical Examination Rhinoscope, History of allergies, Clinical symptoms, Score Rhinoconjunctivitis, Concomitant medication, medical history, skin prick test, Spirometry; Peak Expiratory Flow, Conjunctival provocation testing, diagnostics allergy, Hematology, Biochemistry, Inclusion Criteria

Study part: Visit V0 Screening visit. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Concomitant medication_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Documentation concomitant medication

- 30.10.19 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache

Itemgruppe: Concomitant medication

Study part: Documentation concomitant medication. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological Drug Reaction History

- 16.12.18 - 1 Formular, 2 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Dermatological Drug Reaction History

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the subjects history of dermatological drug reactions. It should be filled out at each treatment period visit. Complete the Dermatological Drug Reaction History pages for each drug reaction experienced. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903

- 03.01.18 - 1 Formular, 16 Itemgruppen, 69 Datenelemente, 1 Sprache

Itemgruppen: Event number, Food allergies, Hymenoptera sting allergy, Latex allergy, 5. Penicillin allergy, Cephalosporin allergy, Aspirin allergy, NSAID allergy, ACE inhibitor allergy, Other allergies, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria (hives), Angioedema, Anaphylactic/Anaphylactoid reaction, Other symptoms of hypersensitivity reaction

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Hypersensitivity Reaction Record - Repeating form (Scheduled visits)

Genetic Screening For HLA-B*5701 Pregnancy Notification Form NCT00340080

- 20.06.17 - 1 Formular, 2 Itemgruppen, 33 Datenelemente, 1 Sprache

Itemgruppen: Pregnancy Notification Form, Drug exposures

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Pregnancy Notification Form Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Genetic Screening For HLA-B5701 n Patients with HIV Day 1 NCT00340080 - Genetic Screening For HLA-B5701 Day 1 NCT00340080

- 20.06.17 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache

Itemgruppe: Day 1

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Day 1 (Cohort Study) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Genetic Screening For HLA-B5701 n Patients with HIV Week 1 NCT00340080 - Genetic Screening For HLA-B5701 Week 1 NCT00340080

- 20.06.17 - 1 Formular, 1 Itemgruppe, 18 Datenelemente, 1 Sprache

Itemgruppe: Week 1

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Week 1 Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

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