- 12/01/2021 - 1 Formulário, 19 Grupos de itens, 32 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Serious Adverse Event, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis - Microscopy, Urinalysis - Microscopy , Local Laboratory - Unscheduled Clinical Chemistry, Local Laboratory - Unscheduled Clinical Chemistry , Local Laboratory - Unscheduled Haematology, Local Laboratory - Unscheduled Haematology , Unscheduled Urinalysis - Local, Unscheduled Urinalysis - Local, Urinalysis - Microscopy (Unscheduled), Urinalysis - Microscopy (Unscheduled) , Serology - Screen for HIV Antibody and Hepatitis B&C
- 30/10/2019 - 1 Formulário, 19 Grupos de itens, 82 Elementos de dados, 1 Idioma
Grupos de itens: 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
- 10/03/2019 - 1 Formulário, 23 Grupos de itens, 109 Elementos de dados, 1 Idioma
Grupos de itens: 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
- 10/03/2019 - 1 Formulário, 23 Grupos de itens, 107 Elementos de dados, 1 Idioma
Grupos de itens: 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
- 07/03/2019 - 1 Formulário, 25 Grupos de itens, 142 Elementos de dados, 1 Idioma
Grupos de itens: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS
- 06/03/2019 - 1 Formulário, 25 Grupos de itens, 142 Elementos de dados, 1 Idioma
Grupos de itens: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS
- 01/03/2019 - 1 Formulário, 23 Grupos de itens, 109 Elementos de dados, 1 Idioma
Grupos de itens: 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
- 10/10/2017 - 1 Formulário, 18 Grupos de itens, 72 Elementos de dados, 1 Idioma
Grupos de itens: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature

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