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This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.
This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1.
240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio.
The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zagreb(≥6 to ≤17 Years) | Experimental |
| |
| Zagreb(≥51 Years) | Experimental |
| |
| Essen(≥6 to ≤17 Years) | Active Comparator |
| |
| Essen(≥51 Years) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zagreb | Biological | Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years. | Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15) |
| Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years | Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
| Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Days 1 to 7 postvaccination |
| Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengshan Center for Disease Prevention and Control (CDC) | Mengshan | Guangxi | 530028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25692350 | Derived | Li R, Li Y, Wen S, Wen H, Nong Y, Mo Z, Xie F, Pellegrini M. Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study. Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460. |
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All enrolled subjects were included in the trial
Subjects were enrolled at Mengshan CDC
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| ID | Title | Description |
|---|---|---|
| FG000 | Zagreb(≥6 to ≤17 Years) | ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22 |
| FG001 | Essen(≥6 to ≤17 Years) | ≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
| FG002 | Zagreb(≥51 Years) | ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 |
| FG003 | Essen(≥51 Years) | ≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled set:All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Zagreb | Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 |
| BG001 | Essen | Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
| 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 | Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years. | Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before vaccination (day 1) and 14 days after first vaccination (day 15) |
|
Whole study period (From day 1 to day 43)
Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination
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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 | Zagreb(≥6 to ≤17 Years) | ≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 15.0v | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C039481 | hemoglobin A2 Zagreb |
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| Essen | Biological | Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
|
| Days 1 to 7 postvaccination |
| Number of Children Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | From V1/day 1 (postvaccination) through V7/study termination day 43 |
| Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | from V1/day 1 (postvaccination) through V7/study termination day 43 |
| Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
| Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43). |
| Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43). |
| GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43) |
| GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43) |
| The Subject went out of The Trial |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | Subjects |
|
≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22 |
| OG001 | Essen(≥6 to ≤17 Years) | ≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
|
|
|
| Primary | Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years | Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Analysis was done on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
|
|
|
|
| Secondary | Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
|
|
|
| Secondary | Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Before vaccination (day 1) and 14 days after first vaccination (day 15). |
|
|
|
| Secondary | Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Before vaccination (day 1) and 42 days after first vaccination (day 43). |
|
|
|
| Secondary | Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Before vaccination (day 1) and 42 days after first vaccination (day 43). |
|
|
|
| Primary | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | Subjects | Days 1 to 7 postvaccination |
|
|
|
| Primary | Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Analysis was done on the safety set | Posted | Number | Subjects | Days 1 to 7 postvaccination |
|
|
|
| Secondary | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | Concentration (IU/mL) | Before vaccination (day 1) and 42 days after first vaccination (day 43) |
|
|
|
| Secondary | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | Concentration (IU/ml) | Before vaccination (day 1) and 42 days after first vaccination (day 43) |
|
|
|
| Primary | Number of Children Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | Subjects | From V1/day 1 (postvaccination) through V7/study termination day 43 |
|
|
|
| Primary | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | Subjects | from V1/day 1 (postvaccination) through V7/study termination day 43 |
|
|
|
| 0 |
| 121 |
| 64 |
| 121 |
| EG001 | Essen(≥6 to ≤17 Years) | ≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29 | 0 | 119 | 63 | 119 |
| EG002 | Zagreb(≥51 Years) | ≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22 | 1 | 200 | 19 | 200 |
| EG003 | Essen(≥51 Years) | ≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29 | 0 | 200 | 24 | 200 |
| Injection Site Pain | General disorders | MedDRA 15.0v | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.0v | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0v | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0v | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 15.0v | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0v | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 15.0v | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0v | Systematic Assessment |
|
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial
| D007239 | Infections |
| Day 15(58,56,56,54,114, 110) |
|
| Day 15 (93,93,97,95,190, 188) |
|
| Day 43 (57,56,56,55,113,111) |
|
| Day 43 (92,90,96,93,188,183) |
|
| Injection Site Induration(N=59,58,60,60,119,118) |
|
| Injection Site Pain(N=59,58,60,60,119,118) |
|
| Nausea(N=59,58,60,60,119,118) |
|
| Myalgia(N=59,58,60,60,119,118) |
|
| Arthralgia(N=59,58,60,60,119,118) |
|
| Headache(N=59,58,60,60,119,118) |
|
| Fatigue(N=59,58,60,60,119,118) |
|
| Loss of Appetite(N=59,58,60,60,119,118) |
|
| Body Temp. (≥38°C)(N=59,58,60,60,119,118) |
|
| Low Grade Fever(N=59,58,60,60,119,118) |
|
| Medium Grade Fever(N=59,58,60,60,119,118) |
|
| High Grade Fever(N=59,58,60,60,119,118) |
|
| Analge,Antipyr Used(N=59,58,60,60,119,118) |
|
| Injection Site Induration(N=98,100,99,100,197,200) |
|
| Injection Site Pain(N=98,100,99,100,197,200) |
|
| Nausea(N=98,100,99,100,197,200) |
|
| Myalgia(N=98,100,99,100,197,200) |
|
| Arthralgia(N=98,100,99,100,197,200) |
|
| Headache(N=98,100,99,100,197,200) |
|
| Fatigue(N=98,100,99,100,197,200) |
|
| Loss of Appetite(N=98,100,99,100,197,200) |
|
| Body Temp.(≥38°C)(N=98,100,99,100,197,200) |
|
| Low Grade Fever(N=98,100,99,100,197,200) |
|
| Medium Grade Fever(N=98,100,99,100,197,200) |
|
| High Grade Fever(N=98,100,99,100,197,200) |
|
| Analgesic,Antipyretic use(N=98,100,99,100,197,200) |
|
| Day 43(N=57,56,56,55,113,111) |
|
| Day 43(92,90,96,93,188,183) |
|
| Serious AEs |
|
| At least possibly related Serious AEs |
|
| Death |
|
| Premature withdrawals due to AEs |
|
| Serious AEs |
|
| At least possibly related Serious AEs |
|
| Death |
|
| Premature withdrawals due to AEs |
|