Randomized, Open Label Safety Trial of Dapivirine Vaginal... | NCT03965923 | Trialant
NCT03965923
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Aug 12, 2025Actual
Enrollment
1,104Actual
Phase
Phase 3
Conditions
HIV Infections
Interventions
Dapivirine (DPV) Vaginal Ring (VR)
Truvada Tablet
Countries
Malawi
South Africa
Uganda
Zimbabwe
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03965923
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MTN-042
Secondary IDs
ID
Type
Description
Link
38544
Registry Identifier
DAIDS-ES Registry Number
Brief Title
Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy
Official Title
Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 9, 2020Actual
Primary Completion Date
May 13, 2024Actual
Completion Date
May 13, 2024Actual
First Submitted Date
May 24, 2019
First Submission Date that Met QC Criteria
May 24, 2019
First Posted Date
May 29, 2019Actual
Results Waived
Not provided
Results First Submitted Date
May 13, 2025
Results First Submitted that Met QC Criteria
Jul 24, 2025
Results First Posted Date
Aug 12, 2025Actual
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
Jul 24, 2025
Last Update Posted Date
Aug 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.
Detailed Description
The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.
Participants will be assigned to one of three cohorts based on gestational age:
Cohort 1: 36 0/7 weeks - 37 6/7 weeks
Cohort 2: 30 0/7 weeks - 35 6/7 weeks
Cohort 3: 12 0/7 weeks - 29 6/7 weeks
Within each cohort, participants will be randomized to receive either DPV VR or oral Truvada. Participants randomized to the DPV VR will use the VR continuously for approximately one month, replacing the VR each month. Participants taking the Truvada tablet will take one tablet orally per day. Participants will use their assigned study product until their pregnancy outcome, but no later than 41 6/7 weeks of gestation.
Participants will attend several study visits throughout the study and study staff will also contact participants by phone at different timepoints throughout the study.
The total duration of study participation will vary depending on gestational age at time of enrollment and length of pregnancy prior to pregnancy outcome and will range from approximately 12 weeks or less for Cohort 1 to approximately 36 weeks or less for Cohort 3. Infants born to study participants will be followed for approximately 52 weeks.
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,104Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Experimental
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 1 Mothers: Truvada Tablet
Experimental
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Truvada Tablet
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Experimental
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 2 Mothers: Truvada Tablet
Experimental
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Truvada Tablet
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dapivirine (DPV) Vaginal Ring (VR)
Drug
Vaginal ring containing 25 mg of DPV
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With a Composite Safety Endpoint Adverse Event (AE)
All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher.
This measure is the number of participants with at least one composite AE.
Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.
Pregnancy Outcomes
Frequency of different types of pregnancy outcomes among mothers.
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
Secondary Outcomes
Measure
Description
Time Frame
Pregnancy Complications: Frequency of Pregnancy Complications
Frequency of different types of pregnancy complications among mothers.
The categories of pregnancy complications were pre-defined on the case report form, and after the completion of Cohort 1 follow-up there were some changes made to the pregnancy complication categories. In Cohort 1 the category "peripartum hemorrhage" was collected, but in Cohort 2 and 3 this category was removed from the list of pre-defined complications. Two other categories, "antepartum hemorrhage" and "intrapartum hemorrhage", were added to the list for Cohort 2 and Cohort 3. As a result, participants in Cohort 1 were not evaluated for antepartum or intrapartum hemorrhage, while participants in Cohorts 2 and 3 were not evaluated for peripartum hemorrhage. All other complications were collected for all three cohorts, and participants in all three cohorts were evaluated for each complication.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age 18 through 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
At Enrollment, evidence of a viable, intrauterine, singleton pregnancy with sonographic confirmation, including for gestational age assessment.
Note: If adequate (per judgment of Investigator of Record [IoR]/designee) sonographic results are not available from medical records at Screening, an ultrasound must be performed and results be available for review at Enrollment for all Cohorts. The ultrasound should be performed no later than the 36th week of gestation for Cohort 1 or the 28th week of gestation for Cohort 2.
At Enrollment, pregnancy within gestational age limits of the currently enrolling cohort (per the study protocol).
HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithm in the study protocol).
At Screening and Enrollment, intending to continue her pregnancy until delivery.
At Screening and Enrollment, intending to deliver at a health center or hospital where adequate records may be obtained, as defined in site SOPs.
Note: Plans to deliver at a health center or hospital where adequate records may be obtained is inclusionary due to logistical challenges related to collection of vaginal rings (VRs), specimens and delivery outcome data outside of those settings.
At Screening and Enrollment, willing to be randomized at time of enrollment to either of the two study arms, and to continue study product use until delivery.
Able and willing to comply with all study requirements and complete all study procedures.
Able and willing to provide the following:
Informed consent for her and her infant to be screened for and to enroll in MTN-042, as defined in site SOPs.
Adequate locator information, as defined in site SOPs.
Adequate documentation of registration for antenatal care, as defined in site SOPs.
Permission to contact participant's antenatal and postpartum care provider(s) and to obtain copies of antenatal and postpartum care records.
At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation, unless approved by the Protocol Safety Review Team (PSRT).
Exclusion Criteria:
Per participant report at Screening and/or Enrollment, intends to do any of the following during the study participation period:
Use oral pre-exposure prophylaxis (PrEP) outside the context of study participation.
Relocate away from the study site.
Travel away from the study site for a time period that would interfere with study participation.
At Screening or Enrollment, has a positive HIV test.
At Screening or Enrollment, diagnosed with urinary tract infection (UTI), cervicitis, sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per World Health Organization (WHO) guidelines.
Note: Detection of bacterial vaginosis (BV) or candida in the absence of symptoms is not exclusionary. Otherwise eligible participants diagnosed during screening with a UTI, cervicitis, or STI/RTI requiring treatment per WHO guidelines are offered treatment consistent with WHO recommendations. If treatment is completed and symptoms have resolved within 35 days of obtaining informed consent for screening, the participant may be enrolled.
At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding.*
Note: Cervical friability bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Investigator of Record (IoR)/designee is considered expected bleeding and is not exclusionary.
Participant report, clinical evidence and/or antenatal/medical care record of any of the following:
Currently breastfeeding at Enrollment.
Known adverse reaction to any of the study products (ever).
Known adverse reaction to latex and polyurethane (ever).
Symptoms suggestive of acute HIV infection at Screening or Enrollment.
Non-therapeutic injection drug use in the 12 months prior to Enrollment.
Use of HIV post-exposure prophylaxis (PEP) and/or PrEP during the current pregnancy.
Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines during the current pregnancy.
At Screening or Enrollment, known to have any of the following during the current pregnancy:
Multiple gestation
Placenta previa
Cervical cerclage
Abnormal fetal anatomy (in the opinion of the IoR or designee)
Intrauterine growth restriction
Pre-existing or gestational diabetes
Hypertensive disorder of pregnancy
Severe malaria
Treatment for preterm labor
Abnormal quantity of amniotic fluid (oligohydramnios or polyhydramnios)
At Screening, known to have had any of the following in a previous pregnancy:
Intrauterine growth restriction
Gestational diabetes
Hypertensive disorder of pregnancy
Intrauterine fetal demise (estimated gestational age greater than or equal to 20 weeks)
Delivery prior to 37 0/7 weeks
At Enrollment, as determined by the IoR/designee, has any significant obstetrical complication (e.g., premature rupture of membranes, any abnormal placentation) or uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease that would make study participation unsafe.
At Screening, has any of the following laboratory abnormalities:
Positive for hepatitis B surface antigen (HBsAg).
Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to Grade 1.**
Hemoglobin greater than or equal to Grade 2.**
Platelet count greater than or equal to Grade 1.**
Creatinine greater than or equal to Grade 1.**
Estimated creatinine clearance greater than or equal to Grade 2 (Cockcroft Gault formula).**
Glycosuria greater than or equal to Grade 2.**
Proteinuria greater than or equal to Grade 2.**
Note: Otherwise eligible participants with an exclusionary test (other than HBsAg) may be re-tested during the screening process; re-testing procedure details can be found in the MTN-042 Study Specific Procedures (SSP) Manual. If improvement to a non-exclusionary grade or resolution is documented within 35 days of providing informed consent for screening, the participant may be enrolled.
Has any condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
*Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
**DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017.
Accepts Healthy Volunteers
Yes
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
40 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Katherine Bunge, MD, MPH
University of Pittsburgh
Study Chair
Felix Mhlanga, MBChB, MMed
Zengeza Clinical Research Site
Study Chair
Lee Fairlie
Wits RHI Shandukani Research Centre
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Blantyre CRS (Johns Hopkins Research Project/College of Medicine)
Mhlanga FG, Szydlo DW, Mayo AJ, Bunge K, Fairlie L, Nakabiito C, Musara P, Mgodi NM, Dadabhai S, Scheckter R, Anderson PL, Marzinke MA, Chappell C, Gadama LA, Richardson BA, Piper JM, Hillier SL; MTN-042 DELIVER study team. Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial. Lancet HIV. 2026 Mar;13(3):e176-e184. doi: 10.1016/S2352-3018(25)00307-8. Epub 2026 Feb 10.
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
FG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
FG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
FG006
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG007
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
FG008
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG009
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
FG010
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
FG011
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000101 subjects
FG00149 subjects
FG002106 subjects
FG00351 subjects
FG004202 subjects
FG00549 subjects
FG00699 subjects
FG00748 subjects
FG008103 subjects
FG00951 subjects
FG010197 subjects
FG01148 subjects
COMPLETED
FG00098 subjects
FG00146 subjects
FG002102 subjects
FG00349 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Infants were enrolled on their date of birth, so their age in years at enrollment was 0 years by definition and is omitted. Their gestational age at birth is reported as a separate baseline measure.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With a Composite Safety Endpoint Adverse Event (AE)
All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher.
This measure is the number of participants with at least one composite AE.
All mothers who were randomized and enrolled are included. All enrolled infants are included.
Posted
Count of Participants
Participants
Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.
ID
Title
Description
OG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Adverse Events Module
Frequency Threshold
0
Time Frame
Adverse event data were collected over the duration of participants' time on study. For mothers, this ranged up to 36 weeks, depending on the participants' gestational age at enrollment and when their pregnancy outcome occurred. Adverse event data for mothers was collected up to 8 weeks after pregnancy outcome. For infants, their duration of time on study was 1 year.
Description
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. These events are also summarized using the specific Adverse Event Term for the event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ancestor Terms
ID
Term
D003273
Contraceptive Devices
D004864
Equipment and Supplies
D000068698
Tenofovir
D063065
Organophosphonates
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 3 Mothers: Truvada Tablet
Experimental
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Drug: Truvada Tablet
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Experimental
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 1 Infants: Truvada Tablet
Experimental
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Drug: Truvada Tablet
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Experimental
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 2 Infants: Truvada Tablet
Experimental
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Drug: Truvada Tablet
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Experimental
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Drug: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 3 Infants: Truvada Tablet
Experimental
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Drug: Truvada Tablet
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Truvada Tablet
Drug
Tablet taken orally
Cohort 1 Infants: Truvada Tablet
Cohort 1 Mothers: Truvada Tablet
Cohort 2 Infants: Truvada Tablet
Cohort 2 Mothers: Truvada Tablet
Cohort 3 Infants: Truvada Tablet
Cohort 3 Mothers: Truvada Tablet
Emtricitabine/Tenofovir Disoproxil Fumarate
FTC/TDF
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)
Infant blood TFV-DP was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a TFV-DP concentration above the lower limit of quantification (LLOQ) for the assay.
Measured at the 2-week post pregnancy outcome (PPO) visit
Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)
Infant blood FTC-TP was measured at infants' PPO visit. The outcome is defined as having detectable drug level, with detectable drug levels defined as a FTC-TP concentration above the lower limit of quantification (LLOQ) for the assay.
measured at the 2-week post pregnancy outcome (PPO) visit
Infant Drug Levels: Number of Infants With Detectable Plasma DPV
Infant plasma DPV concentration was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a DPV concentration above the lower limit of quantification (LLOQ) for the assay.
measured at the 2-week post pregnancy outcome (PPO) visit
Adherence: Maternal Blood TFV-DP Concentrations
Maternal blood TFV-DP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants. Participants are categorized as ever being exposed if they had at least one measure that was >= 200 fmol/punch (if the sample was collected more than 6 weeks after randomization) or >= 150 fmol/punch (if the sample was collected within 6 weeks of randomization). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
Adherence: Maternal Blood FTC-TP Concentrations
Maternal blood FTC-TP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants.
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
Adherence: Maternal Plasma DPV Concentrations
Maternal plasma DPV was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for a randomly selected subset of participants (approximately 50%) randomized to receive the VR. Participants are categorized as ever being exposed if they had at least one measure that was greater than the LLOQ (i.e., greater than or equal to 20 pg/mL). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
Adherence: Frequency of Missing Taking the Pills
Based on participant report, as defined by self-reported missed doses for oral Truvada. This was only reported by participants in Cohorts 2 and 3.
Measured at Week 4 and PPO visits
Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)
Residual drug levels were collected from returned VRs, which were expected to be returned at monthly visits throughout study follow-up. Drug release rate was calculated by subtracting the residual level from the amount of residual drug in the manufacturer lot, divided by the number of days the participant was expected to use that ring, times 28 days. For each individual ring, a ring was considered to show evidence of use if the residual drug level was greater than or equal to 0.9mg/28 days of use.
Participants are categorized as either ever being exposed or never being exposed to product over the course of study follow-up. They are categorized as ever being exposed to product if they had at least one ring with evidence of use (i.e., greater than or equal to 0.9 mg/28 days of release). They are categorized as never being exposed if they had at least one analyzable returned ring and none of these rings had evidence of use.
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Based on participant report of whether they would be willing to use the study product they were randomized to receive when pregnant in the future. Only asked of participants in Cohorts 2 and 3.
Measured at Week 4 and 6-Week PPO/SEV visits.
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
Based on participant report of how much they liked or disliked the study product they were randomized to receive for HIV prevention, and of how much they liked or disliked male condoms for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Measured at Week 4 visits.
Adherence: Frequency of Ring Removal/Expulsion
Based on participant report, as defined by self-reported occurrences of the ring being out of the vagina for more than 12 hours, being out for any time. This was only reported by participants in Cohorts 2 and 3.
Measured at Week 4 visit and Post-Pregnancy Outcome (PPO) (occurring within 2 weeks of pregnancy outcome) visit
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Based on participant report of how satisfied they have been with the the study product they were randomized to receive for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Measured at Week 4 visits.
Johannesburg
Gauteng
2001
South Africa
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala
Uganda
Zengeza CRS
Chitungwiza
Mashonaland East Province
Zimbabwe
Derived
Fairlie L, Szydlo DW, Mayo A, Bunge K, Mhlanga F, Piper J, Dadabhai S, Gatsi VM, Horne E, Ssemambo PK, Mandiwa V, Mgodi NM, Owor M, Anderson PL, Marzinke MA, Nakabiito C, Scheckter R, Chappell C, Hillier SL; MTN-042 study team. Safety outcomes among infants whose mothers used the dapivirine vaginal ring or oral PrEP during pregnancy (MTN-042/DELIVER): a randomised phase 3b study. Lancet HIV. 2025 Nov;12(11):e763-e773. doi: 10.1016/S2352-3018(25)00261-9.
Nansimbe J, Mirembe BG, Ssemambo PK, Ssekasi AM, Byogero R, Nalwoga J, Nakabiito C. Exploring pregnant women's experiences with dapivirine vaginal ring insertion during the MTN-042/DELIVER study in Uganda: a description of secondary data. Ther Adv Infect Dis. 2025 Apr 11;12:20499361251332750. doi: 10.1177/20499361251332750. eCollection 2025 Jan-Dec.
198 subjects
FG00548 subjects
FG00693 subjects
FG00743 subjects
FG00895 subjects
FG00949 subjects
FG010189 subjects
FG01148 subjects
4 subjects
FG0051 subjects
FG0066 subjects
FG0075 subjects
FG0088 subjects
FG0092 subjects
FG0108 subjects
FG0110 subjects
1 subjects
FG0042 subjects
FG0050 subjects
FG0064 subjects
FG0073 subjects
FG0084 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0084 subjects
FG0090 subjects
FG0104 subjects
FG0110 subjects
Other reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
BG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
BG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
BG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
BG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
BG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
BG006
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
BG007
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
BG008
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
BG009
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
BG010
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
BG011
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
BG012
Total
Total of all reporting groups
101
BG00149
BG002106
BG00351
BG004202
BG00549
BG00699
BG00748
BG008103
BG00951
BG010197
BG01148
BG0121104
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
ParticipantsBG004202
ParticipantsBG00549
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0100
ParticipantsBG0110
ParticipantsBG012558
Title
Measurements
BG00025.4± 5.4
BG00125.1± 5.4
BG00226.2± 5.5
BG003
Age, Continuous
Infant gestational age at birth
Infants were enrolled on their date of birth, so their age at enrollment was 0 years by definition. In place of age at enrollment, gestational age at birth is reported. This measure is only collected for infants.
Mean
Standard Deviation
weeks
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00699
ParticipantsBG00748
ParticipantsBG008103
ParticipantsBG00951
ParticipantsBG010197
ParticipantsBG01148
ParticipantsBG012546
Title
Measurements
BG00640.1± 1.6
BG00739.6± 1.6
BG00839.6± 1.8
BG009
Sex: Female, Male
The infant analysis population is enrolled infants whose sex at birth was available.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
ParticipantsBG004202
ParticipantsBG00549
ParticipantsBG00699
ParticipantsBG00748
ParticipantsBG008103
ParticipantsBG00950
ParticipantsBG010197
ParticipantsBG01148
ParticipantsBG0121103
Title
Measurements
Female
BG000101
BG00149
BG002106
BG003
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
ParticipantsBG004202
ParticipantsBG00549
ParticipantsBG00699
ParticipantsBG00748
ParticipantsBG008103
ParticipantsBG00951
ParticipantsBG010197
ParticipantsBG01148
ParticipantsBG0121104
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Number
participants
Title
Denominators
Categories
Malawi
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
ParticipantsBG004202
ParticipantsBG00549
ParticipantsBG00699
ParticipantsBG00748
ParticipantsBG008103
ParticipantsBG00951
ParticipantsBG010197
ParticipantsBG01148
ParticipantsBG0121104
Title
Measurements
BG00018
BG0019
BG00226
BG003
South Africa
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
Uganda
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
Zimbabwe
ParticipantsBG000101
ParticipantsBG00149
ParticipantsBG002106
ParticipantsBG00351
OG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG006
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG007
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG008
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG009
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG010
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG011
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG000101
OG00149
OG002106
OG00351
OG004202
OG00549
OG00699
OG00748
OG008103
OG00951
OG010197
OG01148
Title
Denominators
Categories
Title
Measurements
OG0002
OG0016
OG00216
OG0035
OG00424
OG0054
OG00623
OG00715
OG00830
OG00910
OG01048
OG0116
Primary
Pregnancy Outcomes
Frequency of different types of pregnancy outcomes among mothers.
The analysis population is all randomized and enrolled participants with an obtainable pregnancy outcome. The number of units analyzed is the number of pregnancy outcomes, due to the potential for participants to have non-singleton pregnancies.
Posted
Count of Units
Obtainable pregnancy outcomes
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
Obtainable pregnancy outcomes
Obtainable pregnancy outcomes
ID
Title
Description
OG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00099
OG00149
OG002104
OG003
Title
Denominators
Categories
Title
Measurements
Full term live birth (>= 37 0/7 weeks)
OG00098
OG00145
OG00297
OG003
Secondary
Pregnancy Complications: Frequency of Pregnancy Complications
Frequency of different types of pregnancy complications among mothers.
The categories of pregnancy complications were pre-defined on the case report form, and after the completion of Cohort 1 follow-up there were some changes made to the pregnancy complication categories. In Cohort 1 the category "peripartum hemorrhage" was collected, but in Cohort 2 and 3 this category was removed from the list of pre-defined complications. Two other categories, "antepartum hemorrhage" and "intrapartum hemorrhage", were added to the list for Cohort 2 and Cohort 3. As a result, participants in Cohort 1 were not evaluated for antepartum or intrapartum hemorrhage, while participants in Cohorts 2 and 3 were not evaluated for peripartum hemorrhage. All other complications were collected for all three cohorts, and participants in all three cohorts were evaluated for each complication.
The analysis population is all randomized and enrolled participants with an obtainable pregnancy outcome. The number of units analyzed is the number of pregnancy outcomes, due to the potential for participants to have non-singleton pregnancies.
Posted
Count of Units
Obtainable pregnancy outcomes
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
Obtainable pregnancy outcomes
Obtainable pregnancy outcomes
ID
Title
Description
OG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00099
OG00149
OG002104
OG003
Title
Denominators
Categories
Hypertensive disorders of pregnancy
ParticipantsOG00099
ParticipantsOG00149
ParticipantsOG002104
ParticipantsOG003
Secondary
Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)
Infant blood TFV-DP was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a TFV-DP concentration above the lower limit of quantification (LLOQ) for the assay.
Enrolled infants with an analyzable sample collected at the PPO visit.
Posted
Count of Participants
Participants
Measured at the 2-week post pregnancy outcome (PPO) visit
ID
Title
Description
OG000
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG001
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00044
OG00150
OG00243
Title
Denominators
Categories
Title
Measurements
OG00030
OG00135
OG00230
Secondary
Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)
Infant blood FTC-TP was measured at infants' PPO visit. The outcome is defined as having detectable drug level, with detectable drug levels defined as a FTC-TP concentration above the lower limit of quantification (LLOQ) for the assay.
Enrolled infants with an analyzable sample collected at the PPO visit.
Posted
Count of Participants
Participants
measured at the 2-week post pregnancy outcome (PPO) visit
ID
Title
Description
OG000
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG001
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00044
OG00150
OG00243
Title
Denominators
Categories
Title
Measurements
OG0007
OG0016
OG0021
Secondary
Infant Drug Levels: Number of Infants With Detectable Plasma DPV
Infant plasma DPV concentration was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a DPV concentration above the lower limit of quantification (LLOQ) for the assay.
Enrolled infants with an analyzable sample collected at the PPO visit.
Posted
Count of Participants
Participants
measured at the 2-week post pregnancy outcome (PPO) visit
ID
Title
Description
OG000
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG002
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Units
Counts
Participants
OG00094
OG00197
OG002182
Title
Denominators
Categories
Title
Measurements
OG00022
OG00131
OG00230
Secondary
Adherence: Maternal Blood TFV-DP Concentrations
Maternal blood TFV-DP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants. Participants are categorized as ever being exposed if they had at least one measure that was >= 200 fmol/punch (if the sample was collected more than 6 weeks after randomization) or >= 150 fmol/punch (if the sample was collected within 6 weeks of randomization). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Participants enrolled and randomized to the Truvada Tablet arm who had at least one analyzable blood TFV-DP sample collected during study follow-up.
Posted
Count of Participants
Participants
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
ID
Title
Description
OG000
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG001
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00015
OG00151
OG00249
Title
Denominators
Categories
Title
Measurements
Ever exposed
OG0008
OG00137
OG00241
Never exposed
Secondary
Adherence: Maternal Blood FTC-TP Concentrations
Maternal blood FTC-TP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants.
Participants enrolled and randomized to the Truvada Tablet arm who had an analyzable blood FTC-TP sample collected during at their PPO visit.
Posted
Mean
Standard Deviation
pmol
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
ID
Title
Description
OG000
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG001
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00014
OG00147
OG00245
Title
Denominators
Categories
Title
Measurements
OG0000.1± 0.2
OG0010± 0
OG0020± 0
Secondary
Adherence: Maternal Plasma DPV Concentrations
Maternal plasma DPV was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for a randomly selected subset of participants (approximately 50%) randomized to receive the VR. Participants are categorized as ever being exposed if they had at least one measure that was greater than the LLOQ (i.e., greater than or equal to 20 pg/mL). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Participants enrolled and randomized to the VR arm who had at least one analyzable plasma DPV sample collected during study follow-up.
Posted
Count of Participants
Participants
Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort
ID
Title
Description
OG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG002
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Units
Counts
Participants
OG00048
OG00152
OG002100
Title
Denominators
Categories
Title
Measurements
OG00043
OG00151
OG00298
Secondary
Adherence: Frequency of Missing Taking the Pills
Based on participant report, as defined by self-reported missed doses for oral Truvada. This was only reported by participants in Cohorts 2 and 3.
Participants enrolled and randomized to the Truvada Tablet arm.
Posted
Count of Participants
Participants
Measured at Week 4 and PPO visits
ID
Title
Description
OG000
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG001
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG00051
OG00149
Title
Denominators
Categories
Week 4 Visit
Title
Measurements
Never
OG00036
OG00135
Rarely
OG000
Secondary
Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)
Residual drug levels were collected from returned VRs, which were expected to be returned at monthly visits throughout study follow-up. Drug release rate was calculated by subtracting the residual level from the amount of residual drug in the manufacturer lot, divided by the number of days the participant was expected to use that ring, times 28 days. For each individual ring, a ring was considered to show evidence of use if the residual drug level was greater than or equal to 0.9mg/28 days of use.
Participants are categorized as either ever being exposed or never being exposed to product over the course of study follow-up. They are categorized as ever being exposed to product if they had at least one ring with evidence of use (i.e., greater than or equal to 0.9 mg/28 days of release). They are categorized as never being exposed if they had at least one analyzable returned ring and none of these rings had evidence of use.
Participants enrolled and randomized to the VR arm who had at least one analyzable residual drug level collected during study follow-up.
Posted
Count of Participants
Participants
Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort
ID
Title
Description
OG000
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG002
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Units
Counts
Participants
OG00097
OG001105
OG002199
Title
Denominators
Categories
Title
Measurements
OG00095
OG00193
OG002193
Secondary
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future
Based on participant report of whether they would be willing to use the study product they were randomized to receive when pregnant in the future. Only asked of participants in Cohorts 2 and 3.
Participants enrolled and randomized.
Posted
Count of Participants
Participants
Measured at Week 4 and 6-Week PPO/SEV visits.
ID
Title
Description
OG000
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG000106
OG00151
OG002199
OG003
Title
Denominators
Categories
Week 4 Visit
Title
Measurements
Yes
OG00098
OG00142
OG002193
OG003
Secondary
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods
Based on participant report of how much they liked or disliked the study product they were randomized to receive for HIV prevention, and of how much they liked or disliked male condoms for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Participants enrolled and randomized.
Posted
Count of Participants
Participants
Measured at Week 4 visits.
ID
Title
Description
OG000
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG000106
OG00151
OG002202
OG003
Title
Denominators
Categories
How much do you like or dislike male condoms for HIV prevention
Title
Measurements
Dislike very much
OG00023
OG0015
OG00225
OG003
Secondary
Adherence: Frequency of Ring Removal/Expulsion
Based on participant report, as defined by self-reported occurrences of the ring being out of the vagina for more than 12 hours, being out for any time. This was only reported by participants in Cohorts 2 and 3.
Participants enrolled and randomized to the Truvada Tablet arm.
Posted
Count of Participants
Participants
Measured at Week 4 visit and Post-Pregnancy Outcome (PPO) (occurring within 2 weeks of pregnancy outcome) visit
ID
Title
Description
OG000
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
Units
Counts
Participants
OG000106
OG001202
Title
Denominators
Categories
Ring out for >12 hours in past 4 weeks - Week 4 Visit
Title
Measurements
Never
OG000101
OG001190
Rarely
OG000
Secondary
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV
Based on participant report of how satisfied they have been with the the study product they were randomized to receive for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Participants enrolled and randomized.
Posted
Count of Participants
Participants
Measured at Week 4 visits.
ID
Title
Description
OG000
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG001
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
OG002
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
OG003
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.
Truvada Tablet: Tablet taken orally
Units
Counts
Participants
OG000104
OG00148
OG002199
OG003
Title
Denominators
Categories
Title
Measurements
Very satisfied
OG00068
OG00127
OG002125
OG003
0
101
1
101
43
101
EG001
Cohort 1 Mothers: Truvada Tablet
Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
0
49
3
49
29
49
EG002
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
0
106
8
106
73
106
EG003
Cohort 2 Mothers: Truvada Tablet
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
0
51
2
51
39
51
EG004
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)
Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
0
202
11
202
169
202
EG005
Cohort 3 Mothers: Truvada Tablet
Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation.Truvada Tablet: Tablet taken orally
0
49
2
49
37
49
EG006
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
0
99
14
99
91
99
EG007
Cohort 1 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
1
48
7
48
39
48
EG008
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
4
103
22
103
92
103
EG009
Cohort 2 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
0
51
5
51
44
51
EG010
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm.Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV
4
197
30
197
176
197
EG011
Cohort 3 Infants: Truvada Tablet
Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm.Truvada Tablet: Tablet taken orally
0
48
3
48
43
48
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Congenital absence of bile ducts
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Dysmorphism
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pectus excavatum
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Trisomy 21
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Hyperparathyroidism primary
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Sudden infant death syndrome
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Abscess limb
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Amniotic cavity infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Bronchiolitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0084 events4 affected103 at risk
EG0093 events3 affected51 at risk
EG0104 events4 affected197 at risk
EG0110 events0 affected48 at risk
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Croup infectious
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Dysentery
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gastritis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0071 events1 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0103 events3 affected197 at risk
EG0110 events0 affected48 at risk
Malaria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0104 events4 affected197 at risk
EG0110 events0 affected48 at risk
Neonatal pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0072 events2 affected48 at risk
EG0085 events4 affected103 at risk
EG0091 events1 affected51 at risk
EG0101 events1 affected197 at risk
EG0112 events2 affected48 at risk
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0062 events2 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Sepsis neonatal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0106 events6 affected197 at risk
EG0110 events0 affected48 at risk
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Wound sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Head injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Perineal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0072 events2 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0103 events3 affected197 at risk
EG0110 events0 affected48 at risk
Neonatal hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Diastasis recti abdominis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Hydrocephalus
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0072 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Placenta praevia haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0062 events2 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0111 events1 affected48 at risk
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Pulmonary haemosiderosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
EG0003 events3 affected101 at risk
EG0012 events2 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG00412 events12 affected202 at risk
EG0051 events1 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0023 events3 affected106 at risk
EG0032 events2 affected51 at risk
EG0049 events9 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0051 events1 affected49 at risk
EG0064 events4 affected99 at risk
EG0072 events2 affected48 at risk
EG0082 events2 affected103 at risk
EG0091 events1 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Birth mark
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0111 events1 affected48 at risk
Congenital absence of bile ducts
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Congenital inguinal hernia
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Congenital umbilical hernia
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0072 events2 affected48 at risk
EG0081 events1 affected103 at risk
EG0092 events2 affected51 at risk
EG0107 events7 affected197 at risk
EG0111 events1 affected48 at risk
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0111 events1 affected48 at risk
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Laryngomalacia
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Macrocephaly
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Nail aplasia
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Phimosis
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Polydactyly
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Talipes
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Tethered oral tissue
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blepharitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0083 events3 affected103 at risk
EG0090 events0 affected51 at risk
EG0103 events3 affected197 at risk
EG0110 events0 affected48 at risk
Conjunctivitis allergic
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0091 events1 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Dacryostenosis acquired
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Lacrimation increased
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Retinopathy of prematurity
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0031 events1 affected51 at risk
EG0044 events4 affected202 at risk
EG0051 events1 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Anal skin tags
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0044 events4 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Dental cyst
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0012 events2 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0043 events3 affected202 at risk
EG0051 events1 affected49 at risk
EG0066 events6 affected99 at risk
EG0077 events7 affected48 at risk
EG0089 events9 affected103 at risk
EG0092 events2 affected51 at risk
EG01015 events15 affected197 at risk
EG0116 events6 affected48 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0032 events2 affected51 at risk
EG0043 events3 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Enteritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0103 events3 affected197 at risk
EG0110 events0 affected48 at risk
Eructation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG00414 events14 affected202 at risk
EG0053 events3 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0031 events1 affected51 at risk
EG0042 events2 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Infantile colic
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0018 events8 affected49 at risk
EG0020 events0 affected106 at risk
EG0032 events2 affected51 at risk
EG0041 events1 affected202 at risk
EG0053 events3 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Peptic ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0019 events9 affected49 at risk
EG0020 events0 affected106 at risk
EG0036 events6 affected51 at risk
EG0040 events0 affected202 at risk
EG0053 events3 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0013 events3 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Developmental delay
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Generalised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0051 events1 affected49 at risk
EG0065 events5 affected99 at risk
EG0071 events1 affected48 at risk
EG0084 events4 affected103 at risk
EG0091 events1 affected51 at risk
EG0105 events5 affected197 at risk
EG0112 events2 affected48 at risk
Suprapubic pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Abscess limb
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Abscess of eyelid
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Acarodermatitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Amoebiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Amoebic dysentery
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0063 events3 affected99 at risk
EG0071 events1 affected48 at risk
EG0082 events2 affected103 at risk
EG0091 events1 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Bacterial infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Bacterial vaginosis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Body tinea
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0063 events3 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0111 events1 affected48 at risk
Breast abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Bronchiolitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0104 events4 affected197 at risk
EG0110 events0 affected48 at risk
Bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Bullous impetigo
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0064 events4 affected99 at risk
EG0070 events0 affected48 at risk
EG0084 events4 affected103 at risk
EG0092 events2 affected51 at risk
EG01012 events12 affected197 at risk
EG0114 events4 affected48 at risk
Conjunctivitis bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0063 events3 affected99 at risk
EG0070 events0 affected48 at risk
EG0083 events3 affected103 at risk
EG0092 events2 affected51 at risk
EG0108 events8 affected197 at risk
EG0111 events1 affected48 at risk
Conjunctivitis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Dermatophytosis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Dysentery
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Endometritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Enteritis infectious
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Escherichia urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Fungal skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0110 events0 affected48 at risk
Furuncle
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Gastritis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG00411 events11 affected202 at risk
EG0051 events1 affected49 at risk
EG00615 events15 affected99 at risk
EG0077 events7 affected48 at risk
EG00826 events26 affected103 at risk
EG00913 events13 affected51 at risk
EG01052 events52 affected197 at risk
EG01114 events14 affected48 at risk
Genitourinary chlamydia infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected101 at risk
EG0010 events0 affected49 at risk
EG0024 events4 affected106 at risk
EG0030 events0 affected51 at risk
EG0048 events8 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Genitourinary tract gonococcal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Giardiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Gingivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Hookworm infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Impetigo
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0083 events3 affected103 at risk
EG0093 events3 affected51 at risk
EG0105 events5 affected197 at risk
EG0111 events1 affected48 at risk
Infected cyst
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0043 events3 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0091 events1 affected51 at risk
EG0108 events8 affected197 at risk
EG0111 events1 affected48 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0064 events4 affected99 at risk
EG0070 events0 affected48 at risk
EG0084 events4 affected103 at risk
EG0091 events1 affected51 at risk
EG0105 events5 affected197 at risk
EG0110 events0 affected48 at risk
Malaria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected101 at risk
EG0011 events1 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0043 events3 affected202 at risk
EG0050 events0 affected49 at risk
EG0062 events2 affected99 at risk
EG0070 events0 affected48 at risk
EG0085 events5 affected103 at risk
EG0093 events3 affected51 at risk
EG0103 events3 affected197 at risk
EG0113 events3 affected48 at risk
Mastitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0031 events1 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0046 events6 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0071 events1 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0107 events7 affected197 at risk
EG0111 events1 affected48 at risk
Ophthalmia neonatorum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0065 events5 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0094 events4 affected51 at risk
EG0102 events2 affected197 at risk
EG0111 events1 affected48 at risk
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0073 events3 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG01015 events15 affected197 at risk
EG0114 events4 affected48 at risk
Otitis externa
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Otitis media
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Otitis media acute
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0051 events1 affected49 at risk
EG0063 events3 affected99 at risk
EG0071 events1 affected48 at risk
EG0083 events3 affected103 at risk
EG0092 events2 affected51 at risk
EG0103 events3 affected197 at risk
EG0114 events4 affected48 at risk
Paronychia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0103 events3 affected197 at risk
EG0111 events1 affected48 at risk
Pharyngotonsillitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0072 events2 affected48 at risk
EG0084 events4 affected103 at risk
EG0091 events1 affected51 at risk
EG01021 events21 affected197 at risk
EG0111 events1 affected48 at risk
Postoperative wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Postpartum sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Rhinitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0065 events5 affected99 at risk
EG0070 events0 affected48 at risk
EG0083 events3 affected103 at risk
EG0091 events1 affected51 at risk
EG0101 events1 affected197 at risk
EG0111 events1 affected48 at risk
Schistosomiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Septic rash
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Skin bacterial infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Subcutaneous abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Syphilis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Tinea capitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Tinea cruris
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Tinea infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Tinea versicolour
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Tonsillitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0064 events4 affected99 at risk
EG0072 events2 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0105 events5 affected197 at risk
EG0111 events1 affected48 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected101 at risk
EG0012 events2 affected49 at risk
EG00212 events12 affected106 at risk
EG0037 events7 affected51 at risk
EG00436 events36 affected202 at risk
EG0057 events7 affected49 at risk
EG00654 events54 affected99 at risk
EG00723 events23 affected48 at risk
EG00862 events62 affected103 at risk
EG00933 events33 affected51 at risk
EG010127 events127 affected197 at risk
EG01124 events24 affected48 at risk
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0029 events9 affected106 at risk
EG0035 events5 affected51 at risk
EG00412 events12 affected202 at risk
EG0054 events4 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Varicella
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Varicella zoster virus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Viraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0103 events3 affected197 at risk
EG0111 events1 affected48 at risk
Viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Viral rash
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Vulvovaginal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG00410 events10 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Vulvovaginitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0028 events8 affected106 at risk
EG0030 events0 affected51 at risk
EG00413 events13 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Vulvovaginitis trichomonal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG0044 events4 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Wound cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Wound sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Anal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Chest injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Face injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Foreign body in ear
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Hyphaema
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Incision site discharge
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Incision site pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0011 events1 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Suture related complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0092 events2 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Uterine cervical laceration
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Vulvovaginal injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0012 events2 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0045 events5 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0091 events1 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0023 events3 affected106 at risk
EG0032 events2 affected51 at risk
EG0041 events1 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0083 events3 affected103 at risk
EG0092 events2 affected51 at risk
EG0105 events5 affected197 at risk
EG0110 events0 affected48 at risk
Blood pressure diastolic decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blood pressure diastolic increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blood pressure increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blood pressure systolic increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Blood sodium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Creatinine renal clearance decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected101 at risk
EG0011 events1 affected49 at risk
EG0026 events6 affected106 at risk
EG0033 events3 affected51 at risk
EG00420 events20 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0012 events2 affected49 at risk
EG0022 events2 affected106 at risk
EG0031 events1 affected51 at risk
EG0047 events7 affected202 at risk
EG0053 events3 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0083 events3 affected103 at risk
EG0092 events2 affected51 at risk
EG0106 events6 affected197 at risk
EG0110 events0 affected48 at risk
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0023 events3 affected106 at risk
EG0031 events1 affected51 at risk
EG0043 events3 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0023 events3 affected106 at risk
EG0030 events0 affected51 at risk
EG0045 events5 affected202 at risk
EG0052 events2 affected49 at risk
EG0061 events1 affected99 at risk
EG0070 events0 affected48 at risk
EG0082 events2 affected103 at risk
EG0090 events0 affected51 at risk
EG0102 events2 affected197 at risk
EG0111 events1 affected48 at risk
Feeding disorder
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0111 events1 affected48 at risk
Neonatal hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0101 events1 affected197 at risk
EG0110 events0 affected48 at risk
Weight gain poor
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG00634 events34 affected99 at risk
EG00716 events16 affected48 at risk
EG00845 events45 affected103 at risk
EG00914 events14 affected51 at risk
EG01048 events48 affected197 at risk
EG01111 events11 affected48 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0033 events3 affected51 at risk
EG0044 events4 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected101 at risk
EG0012 events2 affected49 at risk
EG0023 events3 affected106 at risk
EG0032 events2 affected51 at risk
EG0048 events8 affected202 at risk
EG0052 events2 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0021 events1 affected106 at risk
EG0030 events0 affected51 at risk
EG0042 events2 affected202 at risk
EG0051 events1 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0022 events2 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0031 events1 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Soft tissue swelling
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0070 events0 affected48 at risk
EG0081 events1 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected101 at risk
EG0010 events0 affected49 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected49 at risk
EG0060 events0 affected99 at risk
EG0071 events1 affected48 at risk
EG0080 events0 affected103 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected197 at risk
EG0110 events0 affected48 at risk
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)