Partnership for Research on Ebola VACcinations | NCT02876328 | Trialant
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Studies Partnership for Research on Ebola VACcinations NCT02876328 Show options National Institute of Allergy and Infectious Diseases (NIAID)
Ad26.ZEBOV MVA-BN-Filo rVSVΔG-ZEBOV-GP Placebo rVSV boost Guinea Liberia Mali Sierra Leone Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link PREVACEBL3005 Other Identifier LSHTM
Partnership for Research on Ebola VACcinations
Partnership for Research on Ebola VACcinations (PREVAC)
National Institute of Allergy and Infectious Diseases (NIAID) NIH
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Aug 18, 2016
Results First Submitted Date Jul 14, 2022
Results First Submitted that Met QC Criteria Aug 30, 2022
Results First Posted Date Sep 28, 2022 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Jun 14, 2024
Responsible Party, by Official Title Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) NIH
Name Class Partnership for Research on Ebola Virus in Liberia (PREVAIL) NETWORK Institut National de la Santé Et de la Recherche Médicale, France OTHER_GOV London School of Hygiene and Tropical Medicine OTHER
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.
The purpose of this study is to evaluate the safety and immunogenicity of two Ebola virus disease (EVD) vaccines, Ad26.ZEBOV (rHAd26) and rVSVΔG-ZEBOV-GP (rVSV), in children and adults. These vaccines will be studied using three different strategies: the rHAd26 vaccine plus a MVA-BN-Filo (MVA) boost, and the rVSV vaccine with or without boosting.
Participants will be randomized into five groups: the Ad26.ZEBOV vaccine with an MVA boost, the rVSV vaccine with or without boosting, or one of two placebo groups. At Day 0 (study entry), participants will receive the Ad26.ZEBOV vaccine, the rVSV vaccine, or placebo.
At Day 56, participants assigned to the rVSV vaccine without a boost and the two placebo groups will receive placebo. Those initially given the Ad26.ZEBOV vaccine will receive the MVA boost. Those assigned to the boosted rVSV group will receive the rVSV boost.
Additional study visits will occur on Days 7, 14, 28, and 63, and at Months 3, 6, 12, 24, 36, 48, and 60. Study visits may include blood collection and other assessments.
Some participants may take part in substudies, which will include blood or saliva collection.
After the Month 12 visit, during the long-term follow-up, the participants who received the placebo will be vaccinated with a single dose of rVSVΔG-ZEBOV-GP vaccine in Liberia and Mali and with the Ad26.ZEBOV/MVA-BN-Filo vaccine strategy in Guinea and Sierra Leone. The participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy will be offered a single dose of the Ad26.ZEBOV or MVA-BN-Filo vaccine in Guinea and Sierra Leone and a single dose of rVSVΔG-ZEBOV-GP in Liberia and Mali.
Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost Experimental Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Placebo (0.5 mL) Placebo Comparator Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost Experimental Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
Biological: rVSVΔG-ZEBOV-GP Biological: Placebo rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost Experimental Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
Biological: rVSVΔG-ZEBOV-GP Biological: rVSV boost Placebo (1 mL) Placebo Comparator Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Name Type Description Arm Group Labels Other Names Ad26.ZEBOV Biological 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost
Measure Description Time Frame Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.
Measured through Month 12
Measure Description Time Frame Frequency of Serious Adverse Events (SAEs) SAEs as defined in the protocol
Measured through Month 60 Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.
Inclusion Criteria:
Informed consent/assent
Age greater than or equal to 1 year
Planned residency in the area of the study site for the next 12 months
Willingness to comply with the protocol requirements
Exclusion Criteria:
Fever greater than 38º Celsius
History of EVD (self-report)
Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
Positive HIV test for participants less than 18 years of age
Reported current breast-feeding
Prior vaccination against Ebola (self-report)
Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol
Inclusion Criteria for Revaccination Post 12 Month Visit:
Participants who received the placebo
Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:
Fever greater than 38º Celsius
Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
Reported current breast-feeding (self-report)
Any vaccination in the past 28 days or planned within the 28 days after trial vaccination
Exclusion Criteria for Revaccination Post 12 Month Visit:
EVD notified in the electronic case report form
For minor participants: change in HIV status since enrollment (self-report)
Previous Ebola vaccination outside of the study including incomplete vaccine strategies
Known medical history or significant risk factors for a thrombotic and/or thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or MVA-BN-Filo vaccine)
Accepts Healthy Volunteers Yes
Name Affiliation Role Yazdan Yazdanpannah Institut National de la Santé Et de la Recherche Médicale, France Principal Investigator Abdoul Habib Beavogui Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah Principal Investigator Mark Kieh Redemption Hospital Principal Investigator Bailah Leigh University of Sierra Leone Principal Investigator Stephen B. Kennedy Redemption Hospital Principal Investigator Seydou Doumbia Universite des Sciences, des Techniques et des Technologies de Bamako Principal Investigator Samba O. Sow Centre pour le Developpement des Vaccins Principal Investigator
Facility Status City State ZIP Country Contacts Centre national de formation et de recherche en santé rurale (Maferyniah) Conakry Guinea Landreah
PubMed Identifier Type Citation Retractions Result Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chene G, Richert L, Neaton JD, Yazdanpanah Y; PREVAC study team. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9.
Available IPD Information Not provided
No data available
No data is available for this block.
4789 participants were enrolled in the study, however, only 4786 participants are part of the data analysis.
Healthy volunteers were enrolled at 6 sites in 4 countries: Guinea at 2 sites (Landreah and Maferinyah), Liberia (Redemption Hospital), Mali at 2 sites (Center for Vaccine Development and the University Clinical Research Center), and Sierra Leone (Mambolo). Total enrollment includes participants enrolled in all versions of the protocol, but only participants enrolled in version 4.0 of the protocol are included in the primary outcome analysis.
ID Title Description FG000 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
FG001 Placebo (0.5 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG002 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG003 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
FG004 Placebo (1 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG005 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh
FG006 Title: Placebo (0.5 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
FG007 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
FG008 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
FG009 Placebo (1 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
FG010 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
FG011 Placebo (0.5 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG012 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG013 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
FG014 Placebo (1 mL) - Adults (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG015 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
FG016 Placebo (0.5 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
FG017 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
FG018 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
FG019 Placebo (1 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
FG020 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
FG021 Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
FG022 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
FG023 Placebo (0.5 mL) - Children (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED FG000 396 subjects FG001 221 subjects FG002 395 subjects FG003 197 subjects FG004 191 subjects FG005 403 subjects FG006 179 subjects FG007 407 subjects FG008 202 subjects FG009 210 subjects FG010 187 subjects FG011 99 subjects FG012 177 subjects FG013 99 subjects FG014 100 subjects FG015 227 subjects FG016 107 subjects FG017 237 subjects FG018 108 subjects FG019 107 subjects FG020 324 subjects FG021 172 subjects FG022 34 subjects FG023 7 subjects COMPLETED For the primary outcome, Completed is defined as attending the 12 month visit.
FG000 379 subjects FG001 208 subjects FG002 378 subjects FG003 NOT COMPLETED FG000 17 subjects FG001 13 subjects FG002 17 subjects FG003 9 subjects FG004
Type Comment Reasons Death FG000 2 subjects FG001 1 subjects FG002 3 subjects FG003
Baseline Analysis Population Description Not provided
ID Title Description BG000 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Adults and children are analyzed separately.
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 Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.
The analysis population only includes participants from version 4.0 of the protocol. Adults and children are analyzed separately.
Participants with a missing baseline or 12-month antibody result are excluded. Participants with elevated antibody levels at baseline were not excluded. The placebo group is pooled. Percentages of participants that do not yield whole numbers are the result of rounding.
Posted Number percentage of participants Measured through Month 12 ID Title Description OG000 Protocol Version 4.0 Ad26/MVA Ad26.ZEBOV first dose (0.5 mL) followed by an MVA-BN-Filo second dose (0.5 mL) at 56 days
12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete.
AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected.
Systematically assessed AEs were collected via standard checklist.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information test General disorders MedDRA (22.0) Non-systematic Assessment
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Abdominal pain Gastrointestinal disorders MedDRA (22.0) Systematic Assessment
Are all PI(s) employees of the sponsor? No
Title Organization Phone Extension Email John Tierney, Director of Office of the Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases (NIAID) 301.451.5136 JTierney@niaid.nih.gov
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot Yes No No Study Protocol Mar 10, 2018 Jul 14, 2022 SAP No Yes No Statistical Analysis Plan Apr 10, 2020 Jul 14, 2022 ICF No No Yes Informed Consent Form Mar 20, 2018 Jul 14, 2022
Estimated Results First Submitted Date Not provided
ID Term D019142 Hemorrhagic Fever, Ebola
ID Term D006482 Hemorrhagic Fevers, Viral D012327 RNA Virus Infections D014777 Virus Diseases D007239 Infections
No data available
No data is available for this block.
European and Developing Countries Clinical Trials Partnership (EDCTP) OTHER_GOV
Randomized
Intervention Model Description Not provided
Participant Care Provider Investigator Outcomes Assessor
MVA-BN-Filo Biological 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost
rVSVΔG-ZEBOV-GP Biological 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost
Placebo Biological 0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Placebo (0.5 mL) Placebo (1 mL) rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost
rVSV boost Biological 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost
Measured through Month 60
The Redemption Hospital Monrovia Liberia
Centre pour le Développement des Vaccins (CVD) Bamako Mali
University Clinical Research Center (UCRC) Bamako Mali
Mambolo Clinic Kapesseh Sierra Leone
PREVAC Study Team; Kieh M, Richert L, Beavogui AH, Grund B, Leigh B, D'Ortenzio E, Doumbia S, Lhomme E, Sow S, Vatrinet R, Roy C, Kennedy SB, Faye S, Lees S, Millimouno NP, Camara AM, Samai M, Deen GF, Doumbia M, Esperou H, Pierson J, Watson-Jones D, Diallo A, Wentworth D, McLean C, Simon J, Wiedemann A, Dighero-Kemp B, Hensley L, Lane HC, Levy Y, Piot P, Greenwood B, Chene G, Neaton J, Yazdanpanah Y. Randomized Trial of Vaccines for Zaire Ebola Virus Disease. N Engl J Med. 2022 Dec 29;387(26):2411-2424. doi: 10.1056/NEJMoa2200072. Epub 2022 Dec 14.
Derived Beavogui AH, Doumbia S, Kieh M, Leigh B, Sow S, Lhomme E, Ben-Farhat S, Dubois Cauwelaert N, Roy C, Diouf W, Idrissa S, Diarra S, Millimouno NP, Diallo FA, Kamara M, Pratt D, Dicko I, Kennedy SB, Esperou H, Choi EM, Kpetigo AD, D'Ortenzio E, Diallo A, Lancrey-Javal S, Hamze B, Schwimmer C, Wiedemann A, Ayouba A, Peeters M, Lane HC, Higgs E, Watson-Jones D, Yazdanpanah Y, Greenwood B, Richert L, Levy Y; PREVAC study Team. Five-year immunogenicity and safety follow-up of the PREVAC randomized Trial of Vaccines for Zaire Ebola Virus Disease. medRxiv [Preprint]. 2026 Jun 8:2026.05.29.26354050. doi: 10.64898/2026.05.29.26354050.
Derived Kpetigo AD, Alexandre M, Camara A, Beavogui A, Doumbia S, Kieh M, Leigh B, Sow S, Wittkop L, Soutthiphong AA, Berry IM, Fleck S, Akoo P, Hamze B, Watson-Jones D, Kuhn JH, Greenwood B, Richert L, Yazdanpanah Y, Levy Y, Thiebaut R, Prague M; PREVAC Study Team; Lhomme E. Effect of the time of day for vaccination on the immune response to Ebola Virus Disease vaccines: A modeling study from PREVAC randomized trial. PLoS Negl Trop Dis. 2026 Jan 30;20(1):e0013950. doi: 10.1371/journal.pntd.0013950. eCollection 2026 Jan.
Derived Valayer S, Alexandre M, Prague M, Beavogui AH, Doumbia S, Kieh M, Greenwood B, Leigh B, Poupelin M, Schwimmer C, Sow SO, Berry IM, Kuhn JH, Fusco D, Cauwelaert ND, Watson-Jones D, Thiebaut R, Levy Y, Yazdanpanah Y, Richert L, Lhomme E; PREVAC study team. Evaluation of waning of IgG antibody responses after rVSVDeltaG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccines: a modelling study from the PREVAC randomized trial. Emerg Microbes Infect. 2025 Dec;14(1):0. doi: 10.1080/22221751.2024.2432353. Epub 2024 Dec 9.
Derived Wiedemann A, Lhomme E, Huchon M, Foucat E, Bererd-Camara M, Guillaumat L, Yaradouno M, Tambalou J, Rodrigues C, Ribeiro A, Beavogui AH, Lacabaratz C, Thiebaut R, Richert L, Levy Y; Prevac study team. Long-term cellular immunity of vaccines for Zaire Ebola Virus Diseases. Nat Commun. 2024 Sep 3;15(1):7666. doi: 10.1038/s41467-024-51453-z.
Derived Lee AW, Liu K, Lhomme E, Blie J, McCullough J, Onorato MT, Connor L, Simon JK, Dubey S, VanRheenen S, Deutsch J, Owens A, Morgan A, Welebob C, Hyatt D, Nair S, Hamze B, Guindo O, Sow SO, Beavogui AH, Leigh B, Samai M, Akoo P, Serry-Bangura A, Fleck S, Secka F, Lowe B, Watson-Jones D, Roy C, Hensley LE, Kieh M, Coller BG; PREVAC Study Team. Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVDeltaG-ZEBOV-GP Ebola Vaccine (ERVEBO(R)): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults. Clin Infect Dis. 2024 Apr 10;78(4):870-879. doi: 10.1093/cid/ciad693.
188 subjects
FG004 181 subjects
FG005 388 subjects
FG006 175 subjects
FG007 395 subjects
FG008 192 subjects
FG009 202 subjects
FG010 182 subjects
FG011 98 subjects
FG012 172 subjects
FG013 95 subjects
FG014 96 subjects
FG015 223 subjects
FG016 102 subjects
FG017 227 subjects
FG018 106 subjects
FG019 105 subjects
FG020 312 subjects
FG021 164 subjects
FG022 33 subjects
FG023 7 subjects 10 subjects
FG005 15 subjects
FG006 4 subjects
FG007 12 subjects
FG008 10 subjects
FG009 8 subjects
FG010 5 subjects
FG011 1 subjects
FG012 5 subjects
FG013 4 subjects
FG014 4 subjects
FG015 4 subjects
FG016 5 subjects
FG017 10 subjects
FG018 2 subjects
FG019 2 subjects
FG020 12 subjects
FG021 8 subjects
FG022 1 subjects
FG023 0 subjects 0 subjects
FG004 0 subjects
FG005 0 subjects
FG006 1 subjects
FG007 3 subjects
FG008 0 subjects
FG009 1 subjects
FG010 1 subjects
FG011 0 subjects
FG012 0 subjects
FG013 0 subjects
FG014 0 subjects
FG015 0 subjects
FG016 1 subjects
FG017 1 subjects
FG018 0 subjects
FG019 0 subjects
FG020 0 subjects
FG021 1 subjects
FG022 0 subjects
FG023 0 subjects Withdrawal by Subject FG000 0 subjects FG001 2 subjects FG002 3 subjects FG003 3 subjects FG004 0 subjects FG005 1 subjects FG006 0 subjects FG007 1 subjects FG008 1 subjects FG009 2 subjects FG010 0 subjects FG011 0 subjects FG012 0 subjects FG013 0 subjects FG014 0 subjects FG015 0 subjects FG016 1 subjects FG017 3 subjects FG018 0 subjects FG019 0 subjects FG020 1 subjects FG021 0 subjects FG022 0 subjects FG023 0 subjects
Missed 12 Month Visit FG000 15 subjects FG001 10 subjects FG002 11 subjects FG003 6 subjects FG004 10 subjects FG005 14 subjects FG006 3 subjects FG007 8 subjects FG008 9 subjects FG009 5 subjects FG010 4 subjects FG011 1 subjects FG012 5 subjects FG013 4 subjects FG014 4 subjects FG015 4 subjects FG016 3 subjects FG017 6 subjects FG018 2 subjects FG019 2 subjects FG020 11 subjects FG021 7 subjects FG022 1 subjects FG023 0 subjects
BG001 Placebo (0.5 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG002 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG003 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
BG004 Placebo (1 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG005 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh
BG006 Placebo (0.5 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
BG007 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
BG008 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
BG009 Placebo (1 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG010 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
BG011 Placebo (0.5 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG012 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG013 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
BG014 Placebo (1 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG015 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
BG016 Placebo (0.5 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
BG017 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
BG018 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
BG019 Placebo (1 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
BG020 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
BG021 Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
BG022 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
BG023 Placebo (0.5 mL) - Children (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
BG024 Total Total of all reporting groups
396
BG001 221
BG002 395
BG003 197
BG004 191
BG005 403
BG006 179
BG007 407
BG008 202
BG009 210
BG010 187
BG011 99
BG012 177
BG013 99
BG014 100
BG015 227
BG016 107
BG017 237
BG018 108
BG019 107
BG020 324
BG021 172
BG022 34
BG023 7
BG024 4786 Title Denominators Categories Adults Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 187 Participants BG011 99 Participants BG012 177 Participants BG013 99 Participants BG014 100 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 324 Participants BG021 172 Participants BG022 0 Participants BG023 0 Participants BG024 2558 Title Measurements BG000 27 (21 to 40) BG001 28 (20 to 38) BG002 27 (20 to 39) BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Age, Customized Count of Participants Participants Title Denominators Categories 1-4 years Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 403 Participants BG006 179 Participants BG007 407 Participants BG008 202 Participants BG009 210 Participants BG010 187 Participants BG011 99 Participants BG012 177 Participants BG013 99 Participants BG014 100 Participants BG015 227 Participants BG016 107 Participants BG017 237 Participants BG018 108 Participants BG019 107 Participants BG020 324 Participants BG021 172 Participants BG022 34 Participants BG023 7 Participants BG024 4786 5-11 years Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 12-17 years Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Adults >18 years Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197
Sex: Female, Male Adults and children are analyzed separately.
Count of Participants Participants Title Denominators Categories Adults Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 187 Participants BG011 99 Participants BG012 177 Participants BG013 99 Participants BG014 100 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 324 Participants BG021 172 Participants BG022 0 Participants BG023 0 Participants BG024 2558 Title Measurements Female BG000 171 BG001 106 BG002 182 BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Race and Ethnicity Not Collected Race and Ethnicity were not collected from any participant.
Count of Participants Participants Title Denominators Categories Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0 Participants BG004 0 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 0
Region of Enrollment Adults and children are analyzed separately.
Count of Participants Participants Title Denominators Categories Guinea Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 187 Participants BG011 99 Participants BG012 177 Participants BG013 99 Participants BG014 100 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 324 Participants BG021 172 Participants BG022 0 Participants BG023 0 Participants BG024 2558 Title Measurements BG000 121 BG001 72 BG002 130 BG003
Liberia Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Mali Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Sierra Leone Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197
Region of Enrollment Adults and children are analyzed separately.
Count of Participants Participants Title Denominators Categories Guinea Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0 Participants BG004 0 Participants BG005 403 Participants BG006 179 Participants BG007 407 Participants BG008 202 Participants BG009 210 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 227 Participants BG016 107 Participants BG017 237 Participants BG018 108 Participants BG019 107 Participants BG020 0 Participants BG021 0 Participants BG022 34 Participants BG023 7 Participants BG024 2228 Title Measurements BG005 163 BG006 71 BG007 156 BG008
Liberia Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0 Mali Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0 Sierra Leone Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
HIV Positive Adults and children are analyzed separately. HIV positive minors were not included in the study.
Count of Participants Participants Title Denominators Categories Adults Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 187 Participants BG011 99 Participants BG012 177 Participants BG013 99 Participants BG014 100 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 324 Participants BG021 172 Participants BG022 0 Participants BG023 0 Participants BG024 2558 Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Number of Participants with Results for Ebola IgG Concentration (Version 4) The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Count of Participants Participants Title Denominators Categories Adults Participants BG000 396 Participants BG001 221 Participants BG002 395 Participants BG003 197 Participants BG004 191 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 1400 Title Measurements BG000 394 BG001 220 BG002 388 BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4) 66.96 EU/mL is the lower limit of quantification for the Filovirus Animal Nonclinical Group (FANG) enzyme-linked immunosorbent assay (ELISA)
The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Count of Participants Participants Title Denominators Categories Adults Participants BG000 394 Participants BG001 220 Participants BG002 388 Participants BG003 197 Participants BG004 189 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 1388 Title Measurements BG000 142 BG001 78 BG002 144 BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0) The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Count of Participants Participants Title Denominators Categories Adults Participants BG000 394 Participants BG001 220 Participants BG002 388 Participants BG003 197 Participants BG004 189 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 1388 Title Measurements BG000 50 BG001 38 BG002 58 BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Median Ebola IgG Concentration (Version 4.0) The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Median Inter-Quartile Range EU/mL Title Denominators Categories Adults Participants BG000 394 Participants BG001 220 Participants BG002 388 Participants BG003 197 Participants BG004 189 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 1388 Title Measurements BG000 94 (43 to 149) BG001 99 (49 to 158) BG002 92 (45 to 145) BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
Geometric Mean Ebola IgG Concentration (Version 4.0) The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Geometric Mean Standard Deviation EU/mL Title Denominators Categories Adults Participants BG000 394 Participants BG001 220 Participants BG002 388 Participants BG003 197 Participants BG004 189 Participants BG005 0 Participants BG006 0 Participants BG007 0 Participants BG008 0 Participants BG009 0 Participants BG010 0 Participants BG011 0 Participants BG012 0 Participants BG013 0 Participants BG014 0 Participants BG015 0 Participants BG016 0 Participants BG017 0 Participants BG018 0 Participants BG019 0 Participants BG020 0 Participants BG021 0 Participants BG022 0 Participants BG023 0 Participants BG024 1388 Title Measurements BG000 85 ± 2.7 BG001 92 ± 2.8 BG002 87 ± 2.7 BG003
Children Participants BG000 0 Participants BG001 0 Participants BG002 0 Participants BG003 0
OG001 Protocol Version 4.0 rVSV rVSVΔG-ZEBOV-GP first dose (1 mL) followed by placebo second dose (1 mL) at 56 days
OG002 Protocol Version 4.0 rVSV Boost rVSVΔG-ZEBOV-GP first dose(1 mL) followed by an rVSVΔG-ZEBOV-GP dose (1 mL) at 56 days
OG003 Protocol Version 4.0 Pooled Placebo Placebo dose (0.5 mL or 1 mL) followed by a placebo second dose (0.5 mL or 1 mL) at 56 days
Units Counts Participants OG000 755 OG001 756 OG002 374 OG003 741
Title Denominators Categories Adults Participants OG000 374 Participants OG001 371 Participants OG002 185 Participants OG003 377 Title Measurements OG000 40.9 OG001 75.7 OG002 81.1 OG003
Children Participants OG000 381 Participants OG001 385 Participants OG002 189 Participants OG003 364
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description Analysis applies to both adults and children.
Cochran-Mantel-Haenszel Analyses are stratified by site.
<.001 Each active group is compared to placebo using a 2-sided .0167 significance level.
Superiority
Secondary Frequency of Serious Adverse Events (SAEs) SAEs as defined in the protocol
Not Posted Measured through Month 60 Participants
Secondary Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.
Not Posted Measured through Month 60 Participants
EG001 Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
1 412 5 412 291 412
EG002 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
3 395 6 395 320 395
EG003 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
0 197 1 197 155 197
EG004 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh
0 403 5 403 341 403
EG005 Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
2 389 8 389 298 389
EG006 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh
3 407 9 407 350 407
EG007 rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
rVSV boost: 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
0 202 3 202 179 202
EG008 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
1 187 12 187 142 187
EG009 Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
0 199 6 199 151 199
EG010 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
0 177 6 177 148 177
EG011 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
0 99 2 99 80 99
EG012 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
0 227 4 227 167 227
EG013 Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
1 214 7 214 143 214
EG014 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
1 237 6 237 186 237
EG015 rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
rVSV boost: 1 mL of a 1:2 diluted 2x10^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
0 108 1 108 84 108
EG016 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm
0 324 6 324 232 324
EG017 Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm
1 172 5 172 97 172
EG018 Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
0 34 1 34 23 34
EG019 Placebo (0.5 mL) - Children (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
0 7 0 7 4 7
EG000 1 affected 396 at risk
EG001 0 affected 412 at risk
EG002 0 affected 395 at risk
EG003 0 affected 197 at risk
EG004 0 affected 403 at risk
EG005 0 affected 389 at risk
EG006 0 affected 407 at risk
EG007 0 affected 202 at risk
EG008 0 affected 187 at risk
EG009 0 affected 199 at risk
EG010 0 affected 177 at risk
EG011 0 affected 99 at risk
EG012 0 affected 227 at risk
EG013 0 affected 214 at risk
EG014 0 affected 237 at risk
EG015 0 affected 108 at risk
EG016 0 affected 324 at risk
EG017 0 affected 172 at risk
EG018 0 affected 34 at risk
EG019 0 affected 7 at risk ABSCESS LIMB Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABDOMINAL HERNIA Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABDOMINAL PAIN LOWER Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABDOMINAL PAIN UPPER Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABORTION INCOMPLETE Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABORTION SPONTANEOUS Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ABORTION SPONTANEOUS INCOMPLETE Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ACUTE ABDOMEN Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 1 events 1 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 1 events 1 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ANAEMIA Blood and lymphatic system disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 1 events 1 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ANAEMIA; MALARIA General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 1 events 1 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ANAPHYLACTIC REACTION Immune system disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ANKLE FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
APPENDICITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 6 events 6 affected 396 at risk EG001 2 events 2 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 1 events 1 affected 403 at risk EG005 2 events 2 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 2 events 2 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 1 events 1 affected 227 at risk EG013 2 events 2 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 1 events 1 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 1 events 1 affected 34 at risk EG019 0 events 0 affected 7 at risk
APPENDICITIS; VAGINAL DISCHARGE General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ASTHMA Respiratory, thoracic and mediastinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ASTHMATIC CRISIS Respiratory, thoracic and mediastinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
BLINDNESS UNILATERAL Eye disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 1 events 1 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
BURNS FIRST DEGREE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 1 events 1 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
BURNS SECOND DEGREE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
CELLULITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 1 events 1 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
CEREBROVASCULAR ACCIDENT Nervous system disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 1 events 1 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
CLAVICLE FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
COMPARTMENT SYNDROME; HUMERUS FRACTURE General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 1 events 1 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
DEATH General disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 2 events 2 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
DIABETES MELLITUS Metabolism and nutrition disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 1 events 1 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
DIABETES MELLITUS; URINARY TRACT INFECTION General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 1 events 1 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
DIARRHOEA Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 1 events 1 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
DROWNING General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 1 events 1 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ECTOPIC PREGNANCY Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
EYE INJURY Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 1 events 1 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
FRACTURE; TIBIA FRACTURE; FIBULA FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 1 events 1 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
GASTROENTERITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
GASTROINTESTINAL OBSTRUCTION Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
GENITAL HAEMORRHAGE; UTERINE CONTRACTIONS DURING PREGNANCY General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 1 events 1 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
HEAD INJURY Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 1 events 1 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
HEAD INJURY; JAW FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 1 events 1 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
HIV INFECTION Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
HUMERUS FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
HYPERTENSION; DIABETES MELLITUS INADEQUATE CONTROL; KETOACIDOSIS General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 1 events 1 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
INGUINAL HERNIA Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 1 events 1 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
INGUINAL HERNIA; INGUINAL HERNIA Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment Bilateral inguinal hernia and Scrotal hernia (LLT)
EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
INGUINAL HERNIA, OBSTRUCTIVE; INGUINAL HERNIA Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ISCHAEMIC STROKE Nervous system disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
LIMB INJURY; WOUND SECRETION Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
LOWER LIMB FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
MALARIA Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 1 events 1 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
MALARIA; ACUTE ABDOMEN; ANAEMIA OF PREGNANCY General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 1 events 1 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
MALARIA; GENITAL INFECTION; APPENDICITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
METRORRHAGIA Reproductive system and breast disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 1 events 1 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 1 events 1 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
OBSTRUCTED LABOUR Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 1 events 1 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PERITONEAL HAEMORRHAGE Gastrointestinal disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PERITONITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PERITONITIS; GASTRIC PERFORATION General disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PNEUMONIA Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PREMATURE SEPARATION OF PLACENTA Pregnancy, puerperium and perinatal conditions MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PRURITUS GENERALISED Skin and subcutaneous tissue disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 1 events 1 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PULMONARY TUBERCULOSIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
PYREXIA General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
RADIUS FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 1 events 1 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
RADIUS FRACTURE; ULNA FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
ROAD TRAFFIC ACCIDENT Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 1 events 1 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SALMONELLOSIS; SALPINGITIS; PYELONEPHRITIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SEPSIS Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 1 events 1 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SICKLE CELL ANAEMIA WITH CRISIS Blood and lymphatic system disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SKIN ULCER Skin and subcutaneous tissue disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 1 events 1 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SNAKE BITE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 1 events 1 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
SUBILEUS; MALNUTRITION; FURUNCLE General disorders MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 1 events 1 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
TYPHOID FEVER Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 1 events 1 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
UTERINE CONTRACTIONS DURING PREGNANCY; ABDOMINAL PAIN; PELVIC PAIN General disorders MedDRA (22.0) Non-systematic Assessment EG000 1 events 1 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
UTERINE LEIOMYOMA Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 1 events 1 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
VENOM POISONING Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 1 events 1 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
WOUND INFECTION Infections and infestations MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 1 events 1 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 0 events 0 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
WRIST FRACTURE Injury, poisoning and procedural complications MedDRA (22.0) Non-systematic Assessment EG000 0 events 0 affected 396 at risk EG001 0 events 0 affected 412 at risk EG002 0 events 0 affected 395 at risk EG003 0 events 0 affected 197 at risk EG004 0 events 0 affected 403 at risk EG005 0 events 0 affected 389 at risk EG006 0 events 0 affected 407 at risk EG007 0 events 0 affected 202 at risk EG008 0 events 0 affected 187 at risk EG009 0 events 0 affected 199 at risk EG010 0 events 0 affected 177 at risk EG011 0 events 0 affected 99 at risk EG012 0 events 0 affected 227 at risk EG013 0 events 0 affected 214 at risk EG014 1 events 1 affected 237 at risk EG015 0 events 0 affected 108 at risk EG016 0 events 0 affected 324 at risk EG017 0 events 0 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
EG000 88 events 70 affected 396 at risk
EG001 99 events 77 affected 412 at risk
EG002 107 events 80 affected 395 at risk
EG003 52 events 39 affected 197 at risk
EG004 169 events 92 affected 403 at risk
EG005 127 events 69 affected 389 at risk
EG006 184 events 97 affected 407 at risk
EG007 95 events 44 affected 202 at risk
EG008 57 events 41 affected 187 at risk
EG009 49 events 36 affected 199 at risk
EG010 47 events 38 affected 177 at risk
EG011 27 events 17 affected 99 at risk
EG012 90 events 53 affected 227 at risk
EG013 88 events 48 affected 214 at risk
EG014 102 events 56 affected 237 at risk
EG015 35 events 24 affected 108 at risk
EG016 60 events 43 affected 324 at risk
EG017 30 events 23 affected 172 at risk
EG018 9 events 7 affected 34 at risk
EG019 2 events 1 affected 7 at risk Arthralgia Musculoskeletal and connective tissue disorders MedDRA (22.0) Systematic Assessment EG000 109 events 79 affected 396 at risk EG001 82 events 63 affected 412 at risk EG002 128 events 94 affected 395 at risk EG003 64 events 45 affected 197 at risk EG004 41 events 28 affected 403 at risk EG005 29 events 18 affected 389 at risk EG006 61 events 38 affected 407 at risk EG007 21 events 14 affected 202 at risk EG008 78 events 52 affected 187 at risk EG009 70 events 48 affected 199 at risk EG010 84 events 57 affected 177 at risk EG011 42 events 29 affected 99 at risk EG012 32 events 24 affected 227 at risk EG013 19 events 15 affected 214 at risk EG014 51 events 31 affected 237 at risk EG015 21 events 12 affected 108 at risk EG016 99 events 66 affected 324 at risk EG017 31 events 22 affected 172 at risk EG018 10 events 4 affected 34 at risk EG019 0 events 0 affected 7 at risk
Chills General disorders MedDRA (22.0) Systematic Assessment EG000 55 events 51 affected 396 at risk EG001 57 events 48 affected 412 at risk EG002 97 events 81 affected 395 at risk EG003 42 events 37 affected 197 at risk EG004 114 events 72 affected 403 at risk EG005 85 events 59 affected 389 at risk EG006 128 events 80 affected 407 at risk EG007 48 events 34 affected 202 at risk EG008 24 events 21 affected 187 at risk EG009 25 events 21 affected 199 at risk EG010 40 events 31 affected 177 at risk EG011 17 events 14 affected 99 at risk EG012 50 events 37 affected 227 at risk EG013 32 events 21 affected 214 at risk EG014 52 events 36 affected 237 at risk EG015 17 events 12 affected 108 at risk EG016 45 events 40 affected 324 at risk EG017 17 events 16 affected 172 at risk EG018 3 events 3 affected 34 at risk EG019 3 events 2 affected 7 at risk
Crying General disorders MedDRA (22.0) Systematic Assessment Only potentially non-verbal children less than 5 years of age assessed.
EG000 0 events 0 affected 0 at risk EG001 0 events 0 affected 0 at risk EG002 0 events 0 affected 0 at risk EG003 0 events 0 affected 0 at risk EG004 39 events 26 affected 137 at risk EG005 28 events 15 affected 136 at risk EG006 48 events 27 affected 123 at risk EG007 26 events 14 affected 71 at risk EG008 0 events 0 affected 0 at risk EG009 0 events 0 affected 0 at risk EG010 0 events 0 affected 0 at risk EG011 0 events 0 affected 0 at risk EG012 5 events 1 affected 25 at risk EG013 1 events 1 affected 24 at risk EG014 5 events 5 affected 24 at risk EG015 1 events 1 affected 9 at risk EG016 0 events 0 affected 0 at risk EG017 0 events 0 affected 0 at risk EG018 0 events 0 affected 0 at risk EG019 0 events 0 affected 0 at risk
Decreased appetite Metabolism and nutrition disorders MedDRA (22.0) Systematic Assessment EG000 69 events 55 affected 396 at risk EG001 61 events 54 affected 412 at risk EG002 98 events 77 affected 395 at risk EG003 41 events 32 affected 197 at risk EG004 162 events 94 affected 403 at risk EG005 127 events 80 affected 389 at risk EG006 220 events 120 affected 407 at risk EG007 118 events 59 affected 202 at risk EG008 58 events 37 affected 187 at risk EG009 55 events 39 affected 199 at risk EG010 73 events 53 affected 177 at risk EG011 29 events 24 affected 99 at risk EG012 82 events 52 affected 227 at risk EG013 48 events 31 affected 214 at risk EG014 110 events 58 affected 237 at risk EG015 41 events 26 affected 108 at risk EG016 58 events 47 affected 324 at risk EG017 27 events 21 affected 172 at risk EG018 12 events 6 affected 34 at risk EG019 0 events 0 affected 7 at risk
Diarrhoea Gastrointestinal disorders MedDRA (22.0) Systematic Assessment EG000 12 events 12 affected 396 at risk EG001 20 events 19 affected 412 at risk EG002 21 events 19 affected 395 at risk EG003 11 events 7 affected 197 at risk EG004 40 events 22 affected 403 at risk EG005 56 events 40 affected 389 at risk EG006 39 events 30 affected 407 at risk EG007 28 events 21 affected 202 at risk EG008 11 events 11 affected 187 at risk EG009 12 events 9 affected 199 at risk EG010 8 events 8 affected 177 at risk EG011 4 events 3 affected 99 at risk EG012 12 events 8 affected 227 at risk EG013 25 events 18 affected 214 at risk EG014 22 events 17 affected 237 at risk EG015 7 events 5 affected 108 at risk EG016 12 events 9 affected 324 at risk EG017 6 events 5 affected 172 at risk EG018 3 events 2 affected 34 at risk EG019 0 events 0 affected 7 at risk
Dizziness Nervous system disorders MedDRA (22.0) Systematic Assessment EG000 53 events 44 affected 396 at risk EG001 52 events 46 affected 412 at risk EG002 67 events 60 affected 395 at risk EG003 18 events 15 affected 197 at risk EG004 70 events 38 affected 403 at risk EG005 49 events 27 affected 389 at risk EG006 96 events 55 affected 407 at risk EG007 33 events 19 affected 202 at risk EG008 35 events 26 affected 187 at risk EG009 49 events 35 affected 199 at risk EG010 45 events 33 affected 177 at risk EG011 22 events 16 affected 99 at risk EG012 15 events 9 affected 227 at risk EG013 22 events 17 affected 214 at risk EG014 29 events 21 affected 237 at risk EG015 16 events 9 affected 108 at risk EG016 45 events 38 affected 324 at risk EG017 22 events 17 affected 172 at risk EG018 3 events 2 affected 34 at risk EG019 3 events 2 affected 7 at risk
Fatigue General disorders MedDRA (22.0) Systematic Assessment EG000 119 events 91 affected 396 at risk EG001 106 events 84 affected 412 at risk EG002 151 events 113 affected 395 at risk EG003 86 events 61 affected 197 at risk EG004 131 events 82 affected 403 at risk EG005 110 events 66 affected 389 at risk EG006 186 events 111 affected 407 at risk EG007 73 events 44 affected 202 at risk EG008 107 events 67 affected 187 at risk EG009 100 events 69 affected 199 at risk EG010 106 events 74 affected 177 at risk EG011 57 events 37 affected 99 at risk EG012 96 events 55 affected 227 at risk EG013 34 events 25 affected 214 at risk EG014 100 events 60 affected 237 at risk EG015 55 events 31 affected 108 at risk EG016 115 events 68 affected 324 at risk EG017 57 events 39 affected 172 at risk EG018 9 events 5 affected 34 at risk EG019 5 events 2 affected 7 at risk
Headache Nervous system disorders MedDRA (22.0) Systematic Assessment EG000 376 events 215 affected 396 at risk EG001 398 events 218 affected 412 at risk EG002 447 events 250 affected 395 at risk EG003 203 events 116 affected 197 at risk EG004 438 events 169 affected 403 at risk EG005 375 events 150 affected 389 at risk EG006 555 events 217 affected 407 at risk EG007 245 events 97 affected 202 at risk EG008 212 events 110 affected 187 at risk EG009 209 events 114 affected 199 at risk EG010 214 events 114 affected 177 at risk EG011 116 events 66 affected 99 at risk EG012 220 events 103 affected 227 at risk EG013 173 events 93 affected 214 at risk EG014 264 events 124 affected 237 at risk EG015 138 events 56 affected 108 at risk EG016 264 events 163 affected 324 at risk EG017 115 events 71 affected 172 at risk EG018 30 events 17 affected 34 at risk EG019 5 events 2 affected 7 at risk
Hyperhidrosis Skin and subcutaneous tissue disorders MedDRA (22.0) Systematic Assessment EG000 7 events 7 affected 396 at risk EG001 6 events 6 affected 412 at risk EG002 9 events 7 affected 395 at risk EG003 7 events 6 affected 197 at risk EG004 22 events 13 affected 403 at risk EG005 15 events 11 affected 389 at risk EG006 22 events 15 affected 407 at risk EG007 3 events 3 affected 202 at risk EG008 4 events 4 affected 187 at risk EG009 5 events 5 affected 199 at risk EG010 8 events 8 affected 177 at risk EG011 2 events 2 affected 99 at risk EG012 6 events 4 affected 227 at risk EG013 5 events 5 affected 214 at risk EG014 12 events 9 affected 237 at risk EG015 6 events 5 affected 108 at risk EG016 12 events 11 affected 324 at risk EG017 11 events 7 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 1 events 1 affected 7 at risk
Mouth ulceration Gastrointestinal disorders MedDRA (22.0) Systematic Assessment EG000 4 events 4 affected 396 at risk EG001 8 events 7 affected 412 at risk EG002 14 events 12 affected 395 at risk EG003 3 events 3 affected 197 at risk EG004 15 events 7 affected 403 at risk EG005 13 events 10 affected 389 at risk EG006 11 events 7 affected 407 at risk EG007 21 events 9 affected 202 at risk EG008 8 events 8 affected 187 at risk EG009 11 events 11 affected 199 at risk EG010 7 events 7 affected 177 at risk EG011 7 events 6 affected 99 at risk EG012 6 events 5 affected 227 at risk EG013 11 events 9 affected 214 at risk EG014 13 events 10 affected 237 at risk EG015 8 events 3 affected 108 at risk EG016 11 events 11 affected 324 at risk EG017 2 events 2 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
Myalgia Musculoskeletal and connective tissue disorders MedDRA (22.0) Systematic Assessment EG000 142 events 105 affected 396 at risk EG001 115 events 92 affected 412 at risk EG002 188 events 138 affected 395 at risk EG003 92 events 68 affected 197 at risk EG004 93 events 62 affected 403 at risk EG005 46 events 38 affected 389 at risk EG006 112 events 78 affected 407 at risk EG007 51 events 32 affected 202 at risk EG008 79 events 56 affected 187 at risk EG009 72 events 54 affected 199 at risk EG010 79 events 61 affected 177 at risk EG011 40 events 33 affected 99 at risk EG012 42 events 34 affected 227 at risk EG013 28 events 24 affected 214 at risk EG014 68 events 50 affected 237 at risk EG015 36 events 25 affected 108 at risk EG016 86 events 76 affected 324 at risk EG017 24 events 23 affected 172 at risk EG018 11 events 6 affected 34 at risk EG019 1 events 1 affected 7 at risk
Nausea Gastrointestinal disorders MedDRA (22.0) Systematic Assessment EG000 31 events 27 affected 396 at risk EG001 46 events 37 affected 412 at risk EG002 61 events 51 affected 395 at risk EG003 29 events 22 affected 197 at risk EG004 42 events 26 affected 403 at risk EG005 37 events 26 affected 389 at risk EG006 61 events 39 affected 407 at risk EG007 15 events 11 affected 202 at risk EG008 23 events 19 affected 187 at risk EG009 20 events 16 affected 199 at risk EG010 26 events 19 affected 177 at risk EG011 14 events 11 affected 99 at risk EG012 26 events 19 affected 227 at risk EG013 17 events 11 affected 214 at risk EG014 16 events 13 affected 237 at risk EG015 15 events 10 affected 108 at risk EG016 23 events 19 affected 324 at risk EG017 24 events 18 affected 172 at risk EG018 3 events 3 affected 34 at risk EG019 1 events 1 affected 7 at risk
Pyrexia General disorders MedDRA (22.0) Systematic Assessment EG000 204 events 156 affected 396 at risk EG001 188 events 135 affected 412 at risk EG002 241 events 180 affected 395 at risk EG003 130 events 87 affected 197 at risk EG004 534 events 261 affected 403 at risk EG005 399 events 192 affected 389 at risk EG006 620 events 278 affected 407 at risk EG007 314 events 145 affected 202 at risk EG008 79 events 55 affected 187 at risk EG009 82 events 52 affected 199 at risk EG010 97 events 69 affected 177 at risk EG011 43 events 34 affected 99 at risk EG012 161 events 88 affected 227 at risk EG013 101 events 68 affected 214 at risk EG014 207 events 114 affected 237 at risk EG015 84 events 45 affected 108 at risk EG016 79 events 66 affected 324 at risk EG017 27 events 24 affected 172 at risk EG018 11 events 8 affected 34 at risk EG019 1 events 1 affected 7 at risk
Skin lesion Skin and subcutaneous tissue disorders MedDRA (22.0) Systematic Assessment EG000 22 events 18 affected 396 at risk EG001 23 events 17 affected 412 at risk EG002 21 events 18 affected 395 at risk EG003 10 events 9 affected 197 at risk EG004 60 events 40 affected 403 at risk EG005 64 events 41 affected 389 at risk EG006 58 events 37 affected 407 at risk EG007 26 events 15 affected 202 at risk EG008 25 events 23 affected 187 at risk EG009 22 events 14 affected 199 at risk EG010 27 events 21 affected 177 at risk EG011 6 events 6 affected 99 at risk EG012 40 events 24 affected 227 at risk EG013 25 events 18 affected 214 at risk EG014 33 events 23 affected 237 at risk EG015 18 events 12 affected 108 at risk EG016 20 events 17 affected 324 at risk EG017 11 events 10 affected 172 at risk EG018 1 events 1 affected 34 at risk EG019 0 events 0 affected 7 at risk
Vomiting Gastrointestinal disorders MedDRA (22.0) Systematic Assessment EG000 16 events 15 affected 396 at risk EG001 16 events 16 affected 412 at risk EG002 28 events 25 affected 395 at risk EG003 13 events 12 affected 197 at risk EG004 70 events 52 affected 403 at risk EG005 53 events 39 affected 389 at risk EG006 77 events 55 affected 407 at risk EG007 38 events 24 affected 202 at risk EG008 1 events 1 affected 187 at risk EG009 11 events 9 affected 199 at risk EG010 6 events 6 affected 177 at risk EG011 2 events 2 affected 99 at risk EG012 27 events 20 affected 227 at risk EG013 21 events 15 affected 214 at risk EG014 29 events 19 affected 237 at risk EG015 14 events 12 affected 108 at risk EG016 2 events 2 affected 324 at risk EG017 5 events 5 affected 172 at risk EG018 0 events 0 affected 34 at risk EG019 0 events 0 affected 7 at risk
Results Disclosure Restriction on PI(s)? No
D018701 Mononegavirales Infections
26
(20 to 35)
BG004 26 (21 to 38)
BG010 30 (23 to 44)
BG011 31 (23 to 40)
BG012 29 (22 to 39)
BG013 28 (22 to 43)
BG014 28 (22 to 39)
BG020 27 (22 to 37)
BG021 27 (22 to 37)
BG024 27 (21 to 39) Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements BG005 8 (4 to 13) BG006 8 (4 to 13) BG007 9 (4 to 12) BG008 8 (3 to 13) BG009 8 (4 to 13) BG015 12 (8 to 15) BG016 12 (8 to 15) BG017 12 (8 to 15) BG018 12 (7 to 15) BG019 12 (7 to 14) BG022 14 (13 to 16) BG023 14 (12 to 15) BG024 10 (5 to 14)
0
BG004 0
BG005 137
BG006 59
BG007 123
BG008 71
BG009 77
BG010 0
BG011 0
BG012 0
BG013 0
BG014 0
BG015 25
BG016 12
BG017 24
BG018 9
BG019 12
BG020 0
BG021 0
BG022 0
BG023 0
BG024 549 Participants BG004 191
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 324
Participants BG021 172
Participants BG022 34
Participants BG023 7
Participants BG024 4786 Title Measurements BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 127 BG006 59 BG007 146 BG008 65 BG009 70 BG010 0 BG011 0 BG012 0 BG013 0 BG014 0 BG015 76 BG016 37 BG017 86 BG018 43 BG019 41 BG020 0 BG021 0 BG022 0 BG023 0 BG024 750
Participants BG004 191
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 324
Participants BG021 172
Participants BG022 34
Participants BG023 7
Participants BG024 4786 Title Measurements BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 139 BG006 61 BG007 138 BG008 66 BG009 63 BG010 0 BG011 0 BG012 0 BG013 0 BG014 0 BG015 126 BG016 58 BG017 127 BG018 56 BG019 54 BG020 0 BG021 0 BG022 34 BG023 7 BG024 929
Participants BG004 191
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 324
Participants BG021 172
Participants BG022 34
Participants BG023 7
Participants BG024 4786 Title Measurements BG000 396 BG001 221 BG002 395 BG003 197 BG004 191 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 187 BG011 99 BG012 177 BG013 99 BG014 100 BG015 0 BG016 0 BG017 0 BG018 0 BG019 0 BG020 324 BG021 172 BG022 0 BG023 0 BG024 2558
87
BG004 81
BG010 99
BG011 45
BG012 75
BG013 43
BG014 49
BG020 120
BG021 60
BG024 1118 Male BG000 225 BG001 115 BG002 213 BG003 110 BG004 110 BG010 88 BG011 54 BG012 102 BG013 56 BG014 51 BG020 204 BG021 112 BG024 1440
Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements Female BG005 186 BG006 87 BG007 185 BG008 85 BG009 95 BG015 122 BG016 48 BG017 117 BG018 55 BG019 53 BG022 19 BG023 5 BG024 1057 Male BG005 217 BG006 92 BG007 222 BG008 117 BG009
66
BG004 63
BG010 144
BG011 80
BG012 141
BG013 77
BG014 76
BG020 158
BG021 84
BG024 1212 Participants
BG004
191
Participants BG005 0
Participants BG006 0
Participants BG007 0
Participants BG008 0
Participants BG009 0
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 324
Participants BG021 172
Participants BG022 0
Participants BG023 0
Participants BG024 2558 Title Measurements BG000 73 BG001 43 BG002 70 BG003 35 BG004 38 BG010 43 BG011 19 BG012 36 BG013 22 BG014 24 BG020 166 BG021 88 BG024 657
Participants
BG004
191
Participants BG005 0
Participants BG006 0
Participants BG007 0
Participants BG008 0
Participants BG009 0
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 324
Participants BG021 172
Participants BG022 0
Participants BG023 0
Participants BG024 2558 Title Measurements BG000 81 BG001 48 BG002 84 BG003 41 BG004 38 BG010 0 BG011 0 BG012 0 BG013 0 BG014 0 BG020 0 BG021 0 BG024 292
Participants BG004 191
Participants BG005 0
Participants BG006 0
Participants BG007 0
Participants BG008 0
Participants BG009 0
Participants BG010 187
Participants BG011 99
Participants BG012 177
Participants BG013 99
Participants BG014 100
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 324
Participants BG021 172
Participants BG022 0
Participants BG023 0
Participants BG024 2558 Title Measurements BG000 121 BG001 58 BG002 111 BG003 55 BG004 52 BG010 0 BG011 0 BG012 0 BG013 0 BG014 0 BG020 0 BG021 0 BG024 397
77
BG009 79
BG015 160
BG016 72
BG017 163
BG018 76
BG019 77
BG022 17
BG023 4
BG024 1115 Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements BG005 64 BG006 25 BG007 66 BG008 33 BG009 30 BG015 67 BG016 35 BG017 74 BG018 32 BG019 30 BG022 17 BG023 3 BG024 476
Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements BG005 95 BG006 40 BG007 94 BG008 46 BG009 51 BG015 0 BG016 0 BG017 0 BG018 0 BG019 0 BG022 0 BG023 0 BG024 326
Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements BG005 81 BG006 43 BG007 91 BG008 46 BG009 50 BG015 0 BG016 0 BG017 0 BG018 0 BG019 0 BG022 0 BG023 0 BG024 311
2
BG004 3
BG010 5
BG011 2
BG012 4
BG013 2
BG014 2
BG020 6
BG021 8
BG024 54 Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 227
Participants BG016 107
Participants BG017 237
Participants BG018 108
Participants BG019 107
Participants BG020 0
Participants BG021 0
Participants BG022 34
Participants BG023 7
Participants BG024 2228 Title Measurements BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG015 0 BG016 0 BG017 0 BG018 0 BG019 0 BG022 0 BG023 0 BG024 0
197
BG004 189
BG024 1388 Participants
BG004
0
Participants BG005 403
Participants BG006 179
Participants BG007 407
Participants BG008 202
Participants BG009 210
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 0
Participants BG021 0
Participants BG022 0
Participants BG023 0
Participants BG024 1401 Title Measurements BG005 398 BG006 177 BG007 401 BG008 200 BG009 209 BG024 1385
66
BG004 68
BG024 498 Participants
BG004
0
Participants BG005 398
Participants BG006 177
Participants BG007 401
Participants BG008 200
Participants BG009 209
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 0
Participants BG021 0
Participants BG022 0
Participants BG023 0
Participants BG024 1385 Title Measurements BG005 198 BG006 87 BG007 187 BG008 97 BG009 101 BG024 670
32
BG004 30
BG024 208 Participants
BG004
0
Participants BG005 398
Participants BG006 177
Participants BG007 401
Participants BG008 200
Participants BG009 209
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 0
Participants BG021 0
Participants BG022 0
Participants BG023 0
Participants BG024 1385 Title Measurements BG005 43 BG006 22 BG007 47 BG008 19 BG009 32 BG024 163
94
(46 to 143)
BG004 94 (47 to 149)
BG024 95 (46 to 148) Participants
BG004
0
Participants BG005 398
Participants BG006 177
Participants BG007 401
Participants BG008 200
Participants BG009 209
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 0
Participants BG021 0
Participants BG022 0
Participants BG023 0
Participants BG024 1385 Title Measurements BG005 67 (29 to 127) BG006 68 (33 to 114) BG007 74 (33 to 122) BG008 69 (33 to 122) BG009 78 (33 to 151) BG024 70 (32 to 128)
91
± 2.7
BG004 87 ± 2.8
BG024 88 ± 2.7 Participants
BG004
0
Participants BG005 398
Participants BG006 177
Participants BG007 401
Participants BG008 200
Participants BG009 209
Participants BG010 0
Participants BG011 0
Participants BG012 0
Participants BG013 0
Participants BG014 0
Participants BG015 0
Participants BG016 0
Participants BG017 0
Participants BG018 0
Participants BG019 0
Participants BG020 0
Participants BG021 0
Participants BG022 0
Participants BG023 0
Participants BG024 1385 Title Measurements BG005 63 ± 3.0 BG006 66 ± 2.8 BG007 67 ± 3.0 BG008 67 ± 3.1 BG009 73 ± 3.1 BG024 66 ± 3.0
2.7
Title Measurements OG000 78.5 OG001 87.3 OG002 92.6 OG003 3.6
115
BG015 105
BG016 59
BG017 120
BG018 53
BG019 54
BG022 15
BG023 2
BG024 1171