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The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 | Experimental |
| |
| Formulation 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK2189242A (formulation 1) | Biological | One dose will be administered intramuscularly at Study Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 7-day (Days 0-6) post-booster vaccination period |
| Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination. | During the 7-day (Days 0-6) post-booster vaccination period |
| Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | During the 31-day (Days 0-30) post-booster vaccination period |
| Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Day 0 to Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD. | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) |
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Inclusion Criteria:
Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 41 years old at the time of vaccination.
Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112993 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2189242A Formulation 1 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
| FG001 | GSK2189242A Formulation 2 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2189242A Formulation 1 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-booster vaccination period |
|
Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post-booster vaccination; SAEs: during the entire study period (from Day 0 up to Day 30).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2189242A Formulation 1 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Pneumococcal vaccine GSK2189242A (formulation 2) | Biological | One dose will be administered intramuscularly at Study Day 0. |
|
| Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening | At Days 1 and 6 post-booster vaccination |
| Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6. | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) |
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 7-day (Days 0-6) post-booster vaccination period |
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. | During the 7-day (Days 0-6) post-booster vaccination period |
| Number of Subjects With Any Unsolicited AEs | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-booster vaccination period |
| Number of Subjects With Any SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Day 0 to Day 30) |
| Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening | At 1 and 6 days post-booster vaccination |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112993 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112993 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112993 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112993 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 |
| GSK2189242A Formulation 2 Group |
Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | GSK2189242A Formulation 2 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. |
|
|
| Primary | Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-booster vaccination period |
|
|
|
| Primary | Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-booster vaccination period |
|
|
|
| Primary | Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 30) |
|
|
|
| Primary | Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | At Days 1 and 6 post-booster vaccination |
|
|
|
| Secondary | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins | Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay. | Posted | Geometric Mean | 95% Confidence Interval | LU/mL | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) |
|
|
|
| Secondary | Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein | Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) |
|
|
|
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-booster vaccination period |
|
|
|
| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-booster vaccination period |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited AEs | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-booster vaccination period |
|
|
|
| Secondary | Number of Subjects With Any SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 30) |
|
|
|
| Secondary | Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities | Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening | The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented. | Posted | Count of Participants | Participants | At 1 and 6 days post-booster vaccination |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 21 |
| 22 |
| EG001 | GSK2189242A Formulation 2 Group | Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0. | 0 | 21 | 0 | 21 | 21 | 21 |
| Redness | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Grade 3 Gastrointestinal symptoms |
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| Related Gastrointestinal symptoms |
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| Grade 3 Headache |
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| Related Headache |
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| Grade 3 Malaise |
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| Related Malaise |
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| Grade 3 Myalgia |
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| Related Myalgia |
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| Grade 3 Fever |
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| Related Fever |
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| AST, Day 6 |
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| Cholesterol, Day 1 |
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| Cholesterol, Day 6 |
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| CRP, Day 1 |
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| CRP, Day 6 |
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| Hemoglobin decrease, Day 1 |
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| Hemoglobin decrease, Day 6 |
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| Haemoglobin, Day 1 |
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| Haemoglobin, Day 6 |
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| LDH, Day 6 |
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| Neutrophils, Day 6 |
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| RBC, Day 1 |
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| RBC, Day 6 |
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| Reticulocytes, Day 6 |
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| WBC, Day 1 |
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| WBC, Day 6 |
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| Overall parameters, Day 1 |
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| Overall parameters, Day 6 |
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| Anti-PhtD, Day 0 |
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| Anti-PhtD, Day 30 |
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| Any Swelling |
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| Any Headache |
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| Any Malaise |
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| Any Myalgia |
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| Any Fever |
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| Grade 1 AST, Day 6 |
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| Grade 1 Cholesterol, Day 1 |
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| Grade 1 Cholesterol, Day 6 |
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| Grade 1 CRP, Day 1 |
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| Grade 1 CRP, Day 6 |
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| Grade 1 Hemoglobin decrease, Day 1 |
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| Grade 1 Hemoglobin decrease, Day 6 |
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| Grade 1 Haemoglobin, Day 1 |
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| Grade 1 Haemoglobin, Day 6 |
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| Grade 1 LDH, Day 6 |
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| Grade 1 Neutrophils, Day 6 |
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| Grade 1 RBC, Day 1 |
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| Grade 1 RBC, Day 6 |
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| Grade 1 Reticulocytes, Day 6 |
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| Grade 1 WBC, Day 1 |
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| Grade 1 WBC, Day 6 |
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| Grade 1 Overall parameters, Day 1 |
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| Grade 1 Overall parameters, Day 6 |
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| Grade 2 ALT, Day 1 |
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| Grade 2 AST, Day 6 |
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| Grade 2 Cholesterol, Day 1 |
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| Grade 2 Cholesterol, Day 6 |
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| Grade 2 CRP, Day 1 |
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| Grade 2 CRP, Day 6 |
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| Grade 2 Hemoglobin decrease, Day 1 |
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| Grade 2 Hemoglobin decrease, Day 6 |
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| Grade 2 Haemoglobin, Day 1 |
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| Grade 2 Haemoglobin, Day 6 |
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| Grade 2 LDH, Day 6 |
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| Grade 2 Neutrophils, Day 6 |
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| Grade 2 RBC, Day 1 |
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| Grade 2 RBC, Day 6 |
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| Grade 2 Reticulocytes, Day 6 |
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| Grade 2 WBC, Day 1 |
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| Grade 2 WBC, Day 6 |
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| Grade 2 Overall parameters, Day 1 |
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| Grade 2 Overall parameters, Day 6 |
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| Grade 4 ALT, Day 1 |
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| Grade 4 AST, Day 6 |
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| Grade 4 Cholesterol, Day 1 |
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| Grade 4 Cholesterol, Day 6 |
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| Grade 4 CRP, Day 1 |
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| Grade 4 CRP, Day 6 |
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| Grade 4 Hemoglobin decrease, Day 1 |
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| Grade 4 Hemoglobin decrease, Day 6 |
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| Grade 4 Haemoglobin, Day 1 |
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| Grade 4 Haemoglobin, Day 6 |
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| Grade 4 LDH, Day 6 |
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| Grade 4 Neutrophils, Day 6 |
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| Grade 4 RBC, Day 1 |
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| Grade 4 RBC, Day 6 |
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| Grade 4 Reticulocytes, Day 6 |
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| Grade 4 WBC, Day 1 |
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| Grade 4 WBC, Day 6 |
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| Grade 4 Overall parameters, Day 1 |
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| Grade 4 Overall parameters, Day 6 |
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