Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine... | NCT02968849

Name	Class
Sanofi	INDUSTRY
GlaxoSmithKline	INDUSTRY
Bill and Melinda Gates Foundation	OTHER

Label	Type	Description	Intervention Names
ALVAC-HIV + subtype C gp120/MF59	Active Comparator	2700 participants will receive an IM injection of ALVAC-HIV (vCP2438) at months 0 and 1, and an IM injection of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, and 12.	Biological: ALVAC-HIV (vCP2438) Biological: Bivalent Subtype C gp120/MF59
Placebo	Placebo Comparator	2700 participants will receive Sodium Chloride for injection, 0.9% at months 0, 1, 3, 6, and 12.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ALVAC-HIV (vCP2438)	Biological	Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose > 10^6 cell culture infectious dose 50% (CCIDv50) and < 1 × 10^8 CCIDv50 (nominal dose of 10^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM

Measure	Description	Time Frame
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.	Measured through 24 months after first vaccination
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.	Measured through 3 full days following each vaccination
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.	Measured through 3 full days following each vaccination
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.	Measured through 3 full days following each vaccination
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

Measure	Description	Time Frame
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment	This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.	Measured through 36 months after first vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age of 18 to 35 years
Sexually active, defined as having had sexual intercourse at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for HIV infection.
Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study prior to first vaccination with verbal demonstration of understanding of all questions.
Agrees not to enroll in another study of an investigational research agent until the participant is unblinded or their study participation ends, whichever occurs last
Good general health as shown by medical history, physical exam, and screening laboratory tests
Willingness to receive HIV test results
Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling.
Alanine aminotransferase (ALT) < 2.5 times the institutional upper limit of normal
Negative HIV-1 and -2 blood test within 30 days prior to enrollment: Sites may use locally available assays that have been approved by HVTN Laboratory Operations.
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
- Agree to consistently use effective contraception (Appendix B and Appendix C) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through 3 months after the last vaccination. Effective contraception is defined as using 2 methods of birth control. These include 1 of the following methods:
  - Condoms (male or female)
  - Diaphragm or cervical cap

PLUS 1 of the following methods:

Intrauterine device (IUD),
Hormonal contraception (in accordance with applicable national contraception guidelines), or
Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or
Any other contraceptive method approved by the protocol safety review team;
- Or not be of reproductive potential, such as having been diagnosed with premature menopause (with no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
  - Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination

Exclusion Criteria

Blood products received within 90 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the study
Pregnant or breastfeeding
HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 702 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure. For volunteers who have received control/placebo in an experimental vaccine trial, the protocol safety review team will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the protocol safety review team on a case-by-case basis.
Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.)
Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Immunodeficiency
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Active tuberculosis (TB) disease
Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mm Hg or diastolic blood pressure (DBP) ≥ 100 mm Hg
Bleeding disorder (diagnosed by a doctor) contraindicating IM injection and/or blood draws, based on investigator's judgment
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure or who is unlikely to experience recurrence of malignancy during the period of the study)
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema

Name	Affiliation	Role
Glenda Gray, MD	Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Walter Sisulu University HIV Vaccine Research Unit CRS		Mthatha	Eastern Cape	5099	South Africa
Kliptown Soweto CRS

PubMed Identifier	Type	Citation	Retractions
33761206	Background	Gray GE, Bekker LG, Laher F, Malahleha M, Allen M, Moodie Z, Grunenberg N, Huang Y, Grove D, Prigmore B, Kee JJ, Benkeser D, Hural J, Innes C, Lazarus E, Meintjes G, Naicker N, Kalonji D, Nchabeleng M, Sebe M, Singh N, Kotze P, Kassim S, Dubula T, Naicker V, Brumskine W, Ncayiya CN, Ward AM, Garrett N, Kistnasami G, Gaffoor Z, Selepe P, Makhoba PB, Mathebula MP, Mda P, Adonis T, Mapetla KS, Modibedi B, Philip T, Kobane G, Bentley C, Ramirez S, Takuva S, Jones M, Sikhosana M, Atujuna M, Andrasik M, Hejazi NS, Puren A, Wiesner L, Phogat S, Diaz Granados C, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, McElrath MJ, Gilbert PB, Janes H, Corey L; HVTN 702 Study Team. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults. N Engl J Med. 2021 Mar 25;384(12):1089-1100. doi: 10.1056/NEJMoa2031499.
35758878

ID	Title	Description
FG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
FG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form	May 20, 2020

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

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment

Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.

MITT cohort

Posted

Number

events per 100 person-years

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG0002695 OG0012689

Title

Denominators

Categories

Cox PH method

Title	Measurements
	OG0000.034 OG0010.033

CIR method

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	The hazard ratio was tested using a sex-stratified log rank test.	0.84		Hazard Ratio (HR)	1.02			2-Sided	95	0.81	1.30			The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.		Other

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.

Safety cohort

Posted

Count of Participants

Participants

Measured through 3 full days following each vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Safety cohort

Posted

Count of Participants

Participants

Measured through 3 full days following each vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Safety cohort

Posted

Count of Participants

Participants

Measured through 3 full days following each vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

For participants reporting multiple AEs over the time frame, the maximum relationship is counted.

Safety cohort

Posted

Count of Participants

Participants

Measured through 30 days after each vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

Safety cohort

Posted

Count of Participants

Participants

Measured through 30 days after each vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Serious Adverse Events (SAEs)

Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).

Safety cohort

Posted

Count of Participants

Participants

Measured through 12 months after last vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Adverse Events of Special Interest (AESIs)

Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.

Safety cohort

Posted

Count of Participants

Participants

Measured through 12 months after last vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting New Chronic Medical Conditions

A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.

Safety cohort

Posted

Count of Participants

Participants

Measured through 12 months after last vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.

Safety cohort

Posted

Count of Participants

Participants

Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.

Safety cohort

Posted

Count of Participants

Participants

Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Primary

Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up

Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.

MITT cohort

Posted

Number

events per 100 person-years

Measured through 36 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment

This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.

Posted

Measured through 36 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment

Week 26 at-risk cohort

Posted

Number

events per 100 person-years

Measured after Month 6.5 through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants

Secondary

Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.

Immunogenicity cohort. "Overall Number of Participants Analyzed" represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. "Number Analyzed" represents those participants with available data after filtering for assay-specific quality control criteria.

Posted

Count of Participants

Participants

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Secondary

Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5

Posted

Count of Participants

Participants

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Secondary

Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.

Posted

Median

Inter-Quartile Range

% T-Cells

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants

Secondary

Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.

Posted

Median

Inter-Quartile Range

% T-Cells

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants

Secondary

Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.

Posted

Count of Participants

Participants

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001

Secondary

Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5

Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M

Posted

Count of Participants

Participants

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001

Secondary

Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5

Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.

Posted

Count of Participants

Participants

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001

Secondary

Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).

Posted

Median

Inter-Quartile Range

net mean fluorescent intensity (net MFI)

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Secondary

Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5

Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).

Posted

Median

Inter-Quartile Range

net mean fluorescent intensity (net MFI)

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Secondary

Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5

Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).

Posted

Median

Inter-Quartile Range

net mean fluorescent intensity (net MFI)

Measured at Month 6.5

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants

Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.

Females in MITT cohort

Posted

Number

events per 100 person-years

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants

Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.

Males in MITT cohort

Posted

Number

events per 100 person-years

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger

Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.

Females in MITT cohort aged 25 or younger

Posted

Number

events per 100 person-years

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25

Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.

Females in MITT cohort older than 25

Posted

Number

events per 100 person-years

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Secondary

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations

Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.

Posted

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants

Secondary

Number of Participants With Viral Sequences at HIV-1 Diagnosis

Number of participants in the female mITT cohort with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 RNA PCR tests from study participants who are diagnosed with HIV-1 infection.

The female mITT cohort was the group of participants used in sieve analysis.

Posted

Count of Participants

Participants

Measured through 24 months after first vaccination

ID	Title	Description
OG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
OG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any Event in SOC	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Anaemia	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Anaemia of pregnancy	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Cardiac arrest	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Palpitations	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Endocrine disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Goitre	Endocrine disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events4 affected2,700 at risk
Abdominal pain upper	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Ascites	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Constipation	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Diarrhoea	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Proctalgia	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0011 events1 affected2,700 at risk
Chest pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Electrocution	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Mass	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Peripheral swelling	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Sudden death	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events4 affected2,704 at risk EG0010 events0 affected2,700 at risk
Bile duct stone	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cholecystitis	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cholelithiasis	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Drug-induced liver injury	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00016 events15 affected2,704 at risk EG00120 events17 affected2,700 at risk
Abscess limb	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Acute hepatitis B	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Appendiceal abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Appendicitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Arthritis bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Cellulitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Central nervous system infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events1 affected2,700 at risk
Gastroenteritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Genital abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Meningitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Meningitis bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events1 affected2,700 at risk
Meningitis tuberculous	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Paronychia	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pelvic inflammatory disease	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pneumonia	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pulmonary tuberculosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pyelonephritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pyelonephritis acute	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Tooth abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tuberculosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG00044 events42 affected2,704 at risk EG00140 events38 affected2,700 at risk
Abdominal injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Accidental overdose	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Ankle fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Back injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Burns second degree	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Chest injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Eye injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Face injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Femur fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Fibula fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Gun shot wound	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0012 events2 affected2,700 at risk
Hand fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Head injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0012 events2 affected2,700 at risk
Humerus fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Joint dislocation	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Limb injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Multiple injuries	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Peripancreatic fluid collection	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Radius fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Skin laceration	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Skull fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Snake bite	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Stab wound	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0017 events7 affected2,700 at risk
Tendon injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Thermal burn	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tibia fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Ulna fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Wrist fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Haemoglobin decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0011 events1 affected2,700 at risk
Back pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Mixed connective tissue disease	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0010 events0 affected2,700 at risk
Epilepsy	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Headache	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Migraine	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Status epilepticus	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Syncope	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0009 events9 affected2,704 at risk EG00112 events12 affected2,700 at risk
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0014 events4 affected2,700 at risk
Breech presentation	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Premature baby	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Premature delivery	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Premature labour	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Stillbirth	Pregnancy, puerperium and perinatal conditions	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG00011 events11 affected2,704 at risk EG00112 events12 affected2,700 at risk
Acute psychosis	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Acute stress disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Anxiety	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Bipolar disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Completed suicide	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Intentional self-injury	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Panic attack	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Psychotic disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Stress	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Suicidal ideation	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Suicide attempt	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Acute kidney injury	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Female reproductive tract disorder	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Testicular torsion	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0013 events3 affected2,700 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Rash	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Hypertensive urgency	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any Event in SOC	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG00012 events11 affected2,704 at risk EG00112 events11 affected2,700 at risk
Anaemia	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0009 events9 affected2,704 at risk EG0015 events5 affected2,700 at risk
Lymphadenitis	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0015 events5 affected2,700 at risk
Neutropenia	Blood and lymphatic system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0011 events1 affected2,700 at risk
Bradycardia	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Palpitations	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Sinus bradycardia	Cardiac disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG0013 events3 affected2,700 at risk
Cerumen impaction	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0012 events2 affected2,700 at risk
Ear discomfort	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Ear pain	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vertigo	Ear and labyrinth disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Endocrine disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Basedow's disease	Endocrine disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG00018 events17 affected2,704 at risk EG00116 events16 affected2,700 at risk
Atopic keratoconjunctivitis	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Chalazion	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Conjunctival haemorrhage	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Conjunctivitis allergic	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0019 events9 affected2,700 at risk
Eye irritation	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Eye pain	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0010 events0 affected2,700 at risk
Eye pruritus	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Eye swelling	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Ocular hyperaemia	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Periorbital pain	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Periorbital swelling	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Photokeratitis	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Swelling of eyelid	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Visual acuity reduced	Eye disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG000165 events151 affected2,704 at risk EG001178 events162 affected2,700 at risk
Abdominal distension	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Abdominal pain	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00022 events22 affected2,704 at risk EG00118 events18 affected2,700 at risk
Abdominal pain lower	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG00115 events15 affected2,700 at risk
Abdominal pain upper	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0015 events5 affected2,700 at risk
Anal pruritus	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Angular cheilitis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Aphthous ulcer	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Breath odour	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Constipation	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG0013 events3 affected2,700 at risk
Dental caries	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0019 events9 affected2,700 at risk
Diarrhoea	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00029 events29 affected2,704 at risk EG00144 events41 affected2,700 at risk
Dyspepsia	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG00110 events10 affected2,700 at risk
Faeces discoloured	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Flatulence	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Gastritis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00015 events15 affected2,704 at risk EG00112 events11 affected2,700 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0016 events5 affected2,700 at risk
Gingival pain	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Haematemesis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Haemorrhoids	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0019 events9 affected2,700 at risk
Inguinal hernia	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Lip swelling	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events2 affected2,700 at risk
Mouth cyst	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Mouth ulceration	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Nausea	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG00111 events11 affected2,700 at risk
Peptic ulcer	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0010 events0 affected2,700 at risk
Proctalgia	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Proctitis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Rectal ulcer	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Stomatitis	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Tooth impacted	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Toothache	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00017 events17 affected2,704 at risk EG00110 events10 affected2,700 at risk
Vomiting	Gastrointestinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG00111 events11 affected2,700 at risk
Any Event in SOC	General disorders	MEDRA 24.1	Non-systematic Assessment	EG000233 events206 affected2,704 at risk EG001218 events198 affected2,700 at risk
Adverse drug reaction	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Axillary pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Chest pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Chills	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Fatigue	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0019 events9 affected2,700 at risk
Hangover	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Hernia	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Influenza like illness	General disorders	MEDRA 24.1	Non-systematic Assessment	EG000181 events166 affected2,704 at risk EG001188 events171 affected2,700 at risk
Injection site bruising	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Injection site dermatitis	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Injection site discolouration	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Injection site erythema	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Injection site pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Injection site pruritus	General disorders	MEDRA 24.1	Non-systematic Assessment	EG00023 events21 affected2,704 at risk EG0012 events2 affected2,700 at risk
Injection site reaction	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Injection site swelling	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Injection site ulcer	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Malaise	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Mass	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Non-cardiac chest pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Oedema peripheral	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Peripheral swelling	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pyrexia	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Swelling face	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vessel puncture site pain	General disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cholelithiasis	Hepatobiliary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Immune system disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0013 events3 affected2,700 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Drug hypersensitivity	Immune system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Food allergy	Immune system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hypersensitivity	Immune system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Any Event in SOC	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002,247 events1,243 affected2,704 at risk EG0012,290 events1,295 affected2,700 at risk
Abdominal abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Abdominal wall abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Abdominal wall infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Abscess jaw	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Abscess limb	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0009 events8 affected2,704 at risk EG00111 events11 affected2,700 at risk
Acarodermatitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00037 events36 affected2,704 at risk EG00137 events34 affected2,700 at risk
Acute hepatitis B	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Acute sinusitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0013 events3 affected2,700 at risk
Anal abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Bacterial urethritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Bacterial vaginosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0017 events7 affected2,700 at risk
Bartholin's abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0012 events2 affected2,700 at risk
Body tinea	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00017 events17 affected2,704 at risk EG00124 events23 affected2,700 at risk
Bronchitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0016 events6 affected2,700 at risk
Cellulitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0016 events6 affected2,700 at risk
Cestode infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Chest wall abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Chlamydial infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0012 events2 affected2,700 at risk
Chronic hepatitis B	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Chronic sinusitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Conjunctivitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG0017 events7 affected2,700 at risk
Conjunctivitis bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Conjunctivitis viral	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Cystitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Dysentery	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Ear infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Ecthyma	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Endometritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Extrapulmonary tuberculosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Folliculitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00020 events20 affected2,704 at risk EG0019 events9 affected2,700 at risk
Fungal skin infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00012 events11 affected2,704 at risk EG0016 events6 affected2,700 at risk
Furuncle	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0015 events4 affected2,700 at risk
Gastritis viral	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Gastroenteritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00050 events46 affected2,704 at risk EG00157 events53 affected2,700 at risk
Gastroenteritis viral	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG0019 events9 affected2,700 at risk
Genital abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital herpes	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0014 events3 affected2,700 at risk
Genital herpes simplex	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital infection fungal	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Genital ulcer syndrome	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG00123 events20 affected2,700 at risk
Genitourinary chlamydia infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG000908 events661 affected2,704 at risk EG001917 events689 affected2,700 at risk
Genitourinary tract gonococcal infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG000332 events286 affected2,704 at risk EG001319 events272 affected2,700 at risk
Genitourinary tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Gingivitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0015 events4 affected2,700 at risk
Gonococcal infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Groin abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Herpes simplex	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Herpes zoster	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hordeolum	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Impetigo	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0009 events9 affected2,704 at risk EG0013 events3 affected2,700 at risk
Implant site abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Implant site infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Infected bite	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Influenza	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0017 events7 affected2,700 at risk
Injection site cellulitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Joint abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Laryngitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Latent syphilis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Lice infestation	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Localised infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Lower respiratory tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00027 events27 affected2,704 at risk EG00120 events18 affected2,700 at risk
Lymphogranuloma venereum	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Male genital tract tuberculosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Nasal abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Nasopharyngitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0006 events5 affected2,704 at risk EG00110 events10 affected2,700 at risk
Omphalitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Onychomycosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Oral herpes	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00011 events11 affected2,704 at risk EG0012 events2 affected2,700 at risk
Oral pustule	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Orchitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0014 events4 affected2,700 at risk
Otitis externa	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0014 events4 affected2,700 at risk
Otitis media	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0012 events2 affected2,700 at risk
Otitis media acute	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Otitis media bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Otitis media chronic	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pelvic abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Pelvic inflammatory disease	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00012 events12 affected2,704 at risk EG0017 events6 affected2,700 at risk
Pharyngitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG0018 events8 affected2,700 at risk
Pharyngotonsillitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Proctitis chlamydial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00032 events27 affected2,704 at risk EG00118 events13 affected2,700 at risk
Proctitis gonococcal	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG00113 events12 affected2,700 at risk
Pulmonary tuberculosis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG00112 events11 affected2,700 at risk
Pustule	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0012 events2 affected2,700 at risk
Pyelonephritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Rash pustular	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Respiratory tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0016 events5 affected2,700 at risk
Respiratory tract infection viral	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Rhinitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00010 events10 affected2,704 at risk EG00111 events10 affected2,700 at risk
Schistosomiasis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Secondary syphilis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events1 affected2,700 at risk
Sexually transmitted disease	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0012 events2 affected2,700 at risk
Sinusitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0008 events7 affected2,704 at risk EG0013 events3 affected2,700 at risk
Skin bacterial infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Subcutaneous abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00026 events24 affected2,704 at risk EG00127 events26 affected2,700 at risk
Syphilis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00046 events41 affected2,704 at risk EG00138 events34 affected2,700 at risk
Syphilis genital	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Tinea capitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tinea cruris	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0011 events1 affected2,700 at risk
Tinea faciei	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tinea infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Tinea pedis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tinea versicolour	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00013 events12 affected2,704 at risk EG00112 events12 affected2,700 at risk
Tonsillitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00033 events31 affected2,704 at risk EG00135 events34 affected2,700 at risk
Tonsillitis bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0013 events3 affected2,700 at risk
Tooth abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tooth infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Upper respiratory tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG000142 events131 affected2,704 at risk EG001127 events119 affected2,700 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Urethritis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00028 events25 affected2,704 at risk EG00135 events31 affected2,700 at risk
Urinary tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00050 events47 affected2,704 at risk EG00153 events50 affected2,700 at risk
Urinary tract infection bacterial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0018 events8 affected2,700 at risk
Urogenital trichomoniasis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0013 events3 affected2,700 at risk
Vaginal infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0013 events3 affected2,700 at risk
Vaginitis chlamydial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0012 events2 affected2,700 at risk
Varicella	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Varicella zoster virus infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vestibulitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Viral infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events5 affected2,700 at risk
Viral pharyngitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0014 events4 affected2,700 at risk
Viral rash	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Viral sinusitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Viral tonsillitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Viral upper respiratory tract infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00014 events14 affected2,704 at risk EG00123 events22 affected2,700 at risk
Vulval abscess	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vulvovaginal candidiasis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG00037 events33 affected2,704 at risk EG00139 events38 affected2,700 at risk
Vulvovaginitis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Vulvovaginitis chlamydial	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vulvovaginitis gonococcal	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vulvovaginitis trichomonal	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG000179 events150 affected2,704 at risk EG001210 events165 affected2,700 at risk
Wound infection	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Wound sepsis	Infections and infestations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG000124 events118 affected2,704 at risk EG00184 events80 affected2,700 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Animal bite	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Ankle fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Arthropod bite	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0014 events4 affected2,700 at risk
Arthropod sting	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Burns first degree	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Chest injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Contusion	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Epicondylitis	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Eye contusion	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Face injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0013 events3 affected2,700 at risk
Fibula fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
First degree chemical burn of skin	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Forearm fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Foreign body in ear	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital contusion	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Gun shot wound	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hand fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Head injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0011 events1 affected2,700 at risk
Herbal toxicity	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Human bite	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events5 affected2,700 at risk
Injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Joint dislocation	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Joint injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG00011 events11 affected2,704 at risk EG0015 events5 affected2,700 at risk
Ligament injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Ligament sprain	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG0012 events2 affected2,700 at risk
Limb injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG00013 events13 affected2,704 at risk EG0016 events6 affected2,700 at risk
Lip injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Multiple injuries	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Muscle strain	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0017 events7 affected2,700 at risk
Neck injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Nerve injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Penis injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Post procedural contusion	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Procedural dizziness	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Procedural pain	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0015 events5 affected2,700 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Skin abrasion	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0014 events4 affected2,700 at risk
Skin laceration	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG00013 events13 affected2,704 at risk EG00110 events10 affected2,700 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0015 events5 affected2,700 at risk
Stab wound	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0014 events4 affected2,700 at risk
Thermal burn	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG0012 events2 affected2,700 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Wrist fracture	Injury, poisoning and procedural complications	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Investigations	MEDRA 24.1	Non-systematic Assessment	EG000108 events92 affected2,704 at risk EG001111 events95 affected2,700 at risk
Alanine aminotransferase increased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Blood glucose increased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Blood pressure increased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG00059 events47 affected2,704 at risk EG00163 events53 affected2,700 at risk
Blood sodium decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Creatinine renal clearance decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0011 events1 affected2,700 at risk
Haemoglobin decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG00042 events38 affected2,704 at risk EG00144 events38 affected2,700 at risk
Neutrophil count decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Weight decreased	Investigations	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG00025 events24 affected2,704 at risk EG00120 events20 affected2,700 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG00011 events11 affected2,704 at risk EG0019 events9 affected2,700 at risk
Decreased appetite	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0007 events6 affected2,704 at risk EG0014 events4 affected2,700 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Hypokalaemia	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Increased appetite	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Iron deficiency	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Malnutrition	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Polydipsia	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00095 events90 affected2,704 at risk EG001106 events98 affected2,700 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00011 events11 affected2,704 at risk EG00120 events20 affected2,700 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Axillary mass	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Back pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00026 events26 affected2,704 at risk EG00133 events29 affected2,700 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0008 events8 affected2,704 at risk EG0013 events3 affected2,700 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0017 events7 affected2,700 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG00111 events11 affected2,700 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00012 events12 affected2,704 at risk EG0015 events5 affected2,700 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0013 events2 affected2,700 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00012 events12 affected2,704 at risk EG00111 events11 affected2,700 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Soft tissue mass	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Soft tissue swelling	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG00014 events12 affected2,704 at risk EG00113 events13 affected2,700 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0005 events4 affected2,704 at risk EG0018 events8 affected2,700 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Penile wart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0011 events1 affected2,700 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Vulvovaginal warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG000178 events165 affected2,704 at risk EG001166 events151 affected2,700 at risk
Burning sensation	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cluster headache	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Dizziness	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG00025 events24 affected2,704 at risk EG00122 events22 affected2,700 at risk
Dyskinesia	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Headache	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG000121 events117 affected2,704 at risk EG001114 events107 affected2,700 at risk
Migraine	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Migraine with aura	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Motor dysfunction	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Neuropathy peripheral	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Nystagmus	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Paraesthesia	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Presyncope	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Radial nerve palsy	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Seizure	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Sensory loss	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Somnolence	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Syncope	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events5 affected2,700 at risk
Tension headache	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG00016 events15 affected2,704 at risk EG00110 events10 affected2,700 at risk
Tremor	Nervous system disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Product Issues	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Device expulsion	Product Issues	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG00019 events17 affected2,704 at risk EG00122 events20 affected2,700 at risk
Acute stress disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Anxiety	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0015 events4 affected2,700 at risk
Depressed mood	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Depression	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0015 events5 affected2,700 at risk
Generalised anxiety disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Insomnia	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events6 affected2,704 at risk EG0013 events3 affected2,700 at risk
Intentional self-injury	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Libido decreased	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Loss of libido	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Panic attack	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Post-traumatic stress disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Premature ejaculation	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Psychotic disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Schizophrenia	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Substance-induced mood disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Suicidal ideation	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Suicide attempt	Psychiatric disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG00021 events20 affected2,704 at risk EG00123 events23 affected2,700 at risk
Chromaturia	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Dysuria	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0018 events8 affected2,700 at risk
Haematuria	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0015 events5 affected2,700 at risk
Ketonuria	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Proteinuria	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG00012 events12 affected2,704 at risk EG0016 events6 affected2,700 at risk
Urethral discharge	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Urethral syndrome	Renal and urinary disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Any Event in SOC	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG000190 events167 affected2,704 at risk EG001193 events176 affected2,700 at risk
Amenorrhoea	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Balanoposthitis	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Bartholin's cyst	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Breast haematoma	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Breast inflammation	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Breast mass	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0013 events3 affected2,700 at risk
Breast pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0013 events3 affected2,700 at risk
Breast tenderness	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cervical cyst	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Cervical dysplasia	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Coital bleeding	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0015 events5 affected2,700 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Dyspareunia	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Erectile dysfunction	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Galactorrhoea	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital rash	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Genital ulceration	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0005 events5 affected2,704 at risk EG0017 events7 affected2,700 at risk
Nipple pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pelvic pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Penile blister	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Penile discharge	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events5 affected2,700 at risk
Penile pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Polycystic ovaries	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pruritus genital	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Sexual dysfunction	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Testicular pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Vaginal discharge	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG000154 events134 affected2,704 at risk EG001142 events132 affected2,700 at risk
Vulval ulceration	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Vulvovaginal discomfort	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Vulvovaginal pain	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0018 events8 affected2,700 at risk
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00055 events53 affected2,704 at risk EG00142 events40 affected2,700 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0011 events1 affected2,700 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG00017 events17 affected2,704 at risk EG00113 events13 affected2,700 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0009 events9 affected2,704 at risk EG00115 events14 affected2,700 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0008 events7 affected2,704 at risk EG0016 events6 affected2,700 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0010 events0 affected2,700 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0013 events3 affected2,700 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0010 events0 affected2,700 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG000147 events136 affected2,704 at risk EG001146 events134 affected2,700 at risk
Acne	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00013 events13 affected2,704 at risk EG0017 events7 affected2,700 at risk
Angioedema	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Blister	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00012 events12 affected2,704 at risk EG00112 events12 affected2,700 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0009 events9 affected2,704 at risk EG0016 events6 affected2,700 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0007 events7 affected2,704 at risk EG0018 events8 affected2,700 at risk
Dry skin	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Eczema	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0018 events8 affected2,700 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Lipohypertrophy	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Miliaria	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Night sweats	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk
Papule	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0011 events1 affected2,700 at risk
Penile ulceration	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0012 events2 affected2,700 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Pruritus	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00022 events20 affected2,704 at risk EG00123 events22 affected2,700 at risk
Pseudofolliculitis	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Rash	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00015 events15 affected2,704 at risk EG00124 events24 affected2,700 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Rash macular	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0004 events4 affected2,704 at risk EG0010 events0 affected2,700 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0015 events5 affected2,700 at risk
Rash papular	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00017 events17 affected2,704 at risk EG00116 events13 affected2,700 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG00015 events15 affected2,704 at risk EG00112 events11 affected2,700 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Skin depigmentation	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0003 events3 affected2,704 at risk EG0013 events3 affected2,700 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Urticaria	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0006 events5 affected2,704 at risk EG0011 events1 affected2,700 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Social circumstances	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0012 events2 affected2,700 at risk
Physical assault	Social circumstances	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Victim of sexual abuse	Social circumstances	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0011 events1 affected2,700 at risk
Any Event in SOC	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG00029 events24 affected2,704 at risk EG00123 events21 affected2,700 at risk
Haematoma	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Hypertension	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG00026 events21 affected2,704 at risk EG00119 events17 affected2,700 at risk
Hypotension	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0002 events2 affected2,704 at risk EG0012 events2 affected2,700 at risk
Orthostatic hypotension	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0000 events0 affected2,704 at risk EG0011 events1 affected2,700 at risk
Phlebitis	Vascular disorders	MEDRA 24.1	Non-systematic Assessment	EG0001 events1 affected2,704 at risk EG0010 events0 affected2,700 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Title	Description
BG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
BG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vaccine	ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18	8	2,704	103	2,704	1,707	2,704
EG001	Placebo	Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18	10	2,700	95	2,700	1,704	2,700