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| ID | Type | Description | Link |
|---|---|---|---|
| FY06-31 | Other Identifier | SIP | |
| S-09-12 | Other Identifier | Sponsor number |
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This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.
The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination | Experimental | Inactivated, Dried, TSI-GSD 104, EEE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, Dried, TSI-GSD 104, EEE | Biological | Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Response Rates for PRNT80 Titers | Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution). | 5 years |
| Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Post dose 2, days 21-35 |
| Response Rates of Pre-Month 6 PRNT80 Titers | Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject Experiencing Local and Systemic Adverse Events | Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster. | vaccination/booster days 0-28 for up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Rivard, MD | USAMRIID Medical Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland | 21702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33899755 | Derived | Schultz JS, Sparks H, Beckham JD. Arboviral central nervous system infections. Curr Opin Infect Dis. 2021 Jun 1;34(3):264-271. doi: 10.1097/QCO.0000000000000729. |
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138 subjects were enrolled at Special Immunizations Clinic, Division of Medicine, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccination | Inactivated, Dried, TSI-GSD 104, EEE Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccination | Inactivated, Dried, TSI-GSD 104, EEE Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period. |
| 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 | Subject Response Rates for PRNT80 Titers | Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution). | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | 5 years |
|
vaccination and booster days 0-28 for up to 5 years
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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 | Vaccination/Booster | Inactivated, Dried, TSI-GSD 104, EEE Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial febrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Cardile, D.O. | USAMRIID Medical Division | 301-619-8833 | anthony.cardile.mil@mail.mil |
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| ID | Term |
|---|---|
| D020242 | Encephalomyelitis, Eastern Equine |
| ID | Term |
|---|---|
| D004683 | Encephalomyelitis, Equine |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| ID | Term |
|---|---|
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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|
|
| Pre-month 6 |
| Response Rates of Post Month 6: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Post month 6, days 21-35 |
| Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Post booster 1, days 21-35 |
| Response Rates of Annual (11-13 Months) PRNT80 Titers | Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Months 11-13 |
| Non-compliance |
|
| Lost to follow up |
|
| Screen failures |
|
| Years of age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Vaccination |
Inactivated, Dried, TSI-GSD 104, EEE Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period. |
|
|
| Primary | Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | Post dose 2, days 21-35 |
|
|
|
| Primary | Response Rates of Pre-Month 6 PRNT80 Titers | Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | Pre-month 6 |
|
|
|
| Primary | Response Rates of Post Month 6: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | Post month 6, days 21-35 |
|
|
|
| Primary | Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers | Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | Post booster 1, days 21-35 |
|
|
|
| Primary | Response Rates of Annual (11-13 Months) PRNT80 Titers | Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. | Only observations or specimens collected according to the protocol were included in the analyses | Posted | Count of Participants | Participants | Months 11-13 |
|
|
|
| Secondary | Number of Subject Experiencing Local and Systemic Adverse Events | Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster. | Posted | Count of Participants | Participants | vaccination/booster days 0-28 for up to 5 years |
|
|
|
| 0 |
| 136 |
| 5 |
| 136 |
| 73 |
| 136 |
| Biscuspid aortic valve | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral pericarditis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal destension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Allergic rhinitis | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Amoebic dysentery | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bicuspic aortic valve | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Chills | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colon cancer | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhea haemorrhagic | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site erythema | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site induration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site paraesthesia | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pruritus | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site swelling | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site warmth | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Middle ear infection | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle strain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vessel puncture site haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral pericarditis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D004679 | Encephalomyelitis |
| D000069544 | Infectious Encephalitis |
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D004671 | Encephalitis, Arbovirus |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| Year: 2010 |
|
| Year: 2011 |
|
| Year: 2013 |
|
| Year: 2014 |
|
| Non-responders |
|
|
| Year: 2010 |
|
| Year: 2011 |
|
| Year: 2013 |
|
| Year: 2014 |
|
| Non-responders |
|
|
| Year: 2010 |
|
| Year: 2011 |
|
| Year: 2012 |
|
| Year: 2013 |
|
| Year: 2014 |
|
| Year: 2015 |
|
| Non-responders |
|
|
| Year: 2010 |
|
| Year: 2011 |
|
| Year: 2013 |
|
| Year: 2014 |
|
| Year: 2015 |
|
| Non-responders |
|
|
| Year: 2010 |
|
| Year: 2011 |
|
| Year: 2013 |
|
| Year: 2014 |
|
| Non-responders |
|
|
| Had AEs: Male subjects |
|
| Had AEs: Female subjects |
|