Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02716675
• Collaborator: (none)
• Enrollment: 2,699
• Locations: 26
• Arms: 3
• Actual Duration (Months): 55.9
• Patients Per Site: 103.8
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: VRC01; Biological: Placebo for VRC01	Phase 2

Detailed Description

This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.

Participants will be randomized to receive VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks. All participants will receive the VRC01 antibody or placebo by IV infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion, participants will be asked to record and report any symptoms to study researchers.

In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5 days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 88, 96, and 104. All study visits will include blood collection and HIV testing and counseling. Select study visits will include a medical history review, physical exam, urine collection, pregnancy testing for participants capable of becoming pregnant, risk reduction counseling, and an interview/questionnaire.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2699 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
• Actual Study Start Date: Apr 6, 2016
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Low-Dose VRC01 Participants will receive an intravenous (IV) infusion of 10 mg/kg of VRC01 over about 15 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.	Biological: VRC01; Administered by IV infusion; total dose will vary based on participant's weight; Other Names: Human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB
Experimental: Group 2: High-Dose VRC01 Participants will receive an IV infusion of 30 mg/kg of VRC01 over about 15 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.	Biological: VRC01; Administered by IV infusion; total dose will vary based on participant's weight; Other Names: Human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB
Placebo Comparator: Group 3: VRC01 Placebo Participants will receive an IV infusion of placebo for VRC01 over about 15 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.	Biological: Placebo for VRC01; Sodium Chloride for Injection USP, 0.9%; administered by IV infusion

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   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

2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration [Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   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

3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.

4. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) [Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   For each local laboratory measure, summary statistics are presented by treatment group and timepoint.

5. Chemistry and Hematology Laboratory Measures - Creatinine [Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   For each local laboratory measure, summary statistics are presented by treatment group and timepoint.

6. Chemistry and Hematology Laboratory Measures - Hemoglobin [Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   For each local laboratory measure, summary statistics are presented by treatment group and timepoint.

7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count [Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   For each local laboratory measure, summary statistics are presented by treatment group and timepoint.

8. Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) [Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   For each local laboratory measure, summary statistics are presented by treatment group and timepoint.

9. Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above [Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72.]

   The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1.

10. Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation [Measured through Week 72 (the last infusion visit).]

    The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form.

11. Incidence Rate of Early Infusion Discontinuation [Measured through Week 72 (the last infusion visit).]

    Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored.

12. Number of Participants With Documented HIV-1 Infection by the Week 80 Visit [Measured through Week 80.]

    Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial.

Secondary Outcome Measures

1. Serum Concentration of VRC01 in Participants Assigned to Receive the mAb [Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.]

   The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals.

2. VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) [Measured through Week 80.]

   The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or >3 μg per milliliter) with the use of the Aalen-Johansen estimator.

3. VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80) [First RNA+ Sample detected from baseline up to Week 104.]

   Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

General and Demographic Criteria

• Age of 18 to 50 years

• Access to a participating clinical research site (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 and completes a questionnaire prior to first infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly

• Agrees not to enroll in another study of an investigational research agent for the duration of the participant's trial participation

• Good general health as shown by medical history, physical exam, and screening laboratory tests

HIV-Related Criteria

• Willingness to receive HIV test results

• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling

• Persons born Male or identifying as Transgender (TG) (male-to-female or female-to-male, see HVTN 704/HPTN 085 SSP) who, in the 6 months prior to randomization, experienced 1 or both of the following HIV risk criteria:

• Condomless anal intercourse with 1 or more male or transgender partner(s)

• Anal intercourse with 2 or more male or transgender partners

• Male-to-female and female-to-male TG volunteers are eligible. Receipt of hormonal therapy does not make a TG volunteer ineligible.

• Volunteers who have been in a mutually monogamous relationship with an HIV-1 seronegative partner for greater than 1 year are excluded.

Laboratory Inclusion Values:

Hematology

• Hemoglobin (Hgb) greater than or equal to 10.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male (greater than or equal to 12.0 g/dL for transgender women taking feminizing hormones [e.g., anti-androgens, estrogens])

• Platelets greater than or equal to 100,000 cells/mm^3

Chemistry

• Alanine aminotransferase (ALT) less than 2.5 times the institutional upper limit of normal and creatinine less than or equal to 1.25 times the institutional upper limit of normal

Virology

• HIV uninfected, as defined in the SSP, within 30 days prior to enrollment

Urine

• Negative, trace, or 1+ (30 g/L for semi-quantitative) urine protein by dipstick

Reproductive Status

• Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed at the screening visit and prior to infusion on the day of initial infusion. Persons who are NOT capable of becoming pregnant 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 is capable of becoming pregnant must agree to consistently use effective contraception (see the protocol and SSP for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit.

• Volunteers capable of becoming pregnant must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Exclusion Criteria:

General

• Investigational research agents received within 30 days before first infusion

• Body mass index (BMI) greater than or equal to 40

• Pregnant or breastfeeding

• Any reactive, indeterminate, or positive HIV test, even if subsequent testing indicates that the individual is not HIV infected, except as permitted by the HVTN 704/HPTN 085 Protocol Safety Review Team (PSRT).

Vaccines

• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 704/HPTN 085 PSRT will determine eligibility on a case-by-case basis.

Immune System

• Serious adverse reactions to VRC01 formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.

• Autoimmune disease, including Type I diabetes mellitus (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require consistent immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and AE assessments)

• Immunodeficiency syndrome

Clinically Significant Medical Conditions

• 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:

• Any contraindication to repeated infusions or blood draws, including inability to establish venous access;

• 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; or

• A condition or process for which signs or symptoms could be confused with reactions to VRC01.

• 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 infusion reactions, 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.

• Asthma, other than mild, well-controlled asthma

• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)

• 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)

• Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.

• History of hereditary angioedema, acquired angioedema, or idiopathic angioedema

• History of receiving transplantation of life-saving organs or tissues (includes heart, kidney, pancreas, lungs, liver, and intestines)

• Known hepatic or renal dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama CRS	Birmingham	Alabama	United States	35294
2	UCLA Vine Street Clinic CRS	Los Angeles	California	United States	90024
3	Bridge HIV CRS	San Francisco	California	United States	94143
4	George Washington Univ. CRS	Washington	District of Columbia	United States	20006
5	The Ponce de Leon Center CRS	Atlanta	Georgia	United States	30308-2012
6	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia	United States	30030
7	Brigham and Women's Hospital Vaccine CRS (BWH VCRS)	Boston	Massachusetts	United States	02115-6110
8	Fenway Health (FH) CRS	Boston	Massachusetts	United States	02215-4302
9	New Jersey Medical School Clinical Research Center CRS	Newark	New Jersey	United States	07103
10	Bronx Prevention Research Center CRS	Bronx	New York	United States	10451
11	Harlem Prevention Center CRS	New York	New York	United States	10027
12	Columbia P&S CRS	New York	New York	United States	10032-3732
13	New York Blood Center CRS	New York	New York	United States	10065
14	University of Rochester Vaccines to Prevent HIV Infection CRS	Rochester	New York	United States	14642
15	Chapel Hill CRS	Chapel Hill	North Carolina	United States	27599
16	Case Clinical Research Site	Cleveland	Ohio	United States	44106
17	Penn Prevention CRS	Philadelphia	Pennsylvania	United States	19104
18	Vanderbilt Vaccine (VV) CRS	Nashville	Tennessee	United States	37232-2582
19	Seattle Vaccine and Prevention CRS	Seattle	Washington	United States	98109-1024
20	Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS	Rio de Janeiro		Brazil	21040-360
21	CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS	Bellavista	Callao	Peru	15081
22	ACSA CRS	Iquitos	Maynas	Peru	1
23	Barranco CRS	Lima		Peru	04
24	San Miguel CRS	Lima		Peru	32
25	Via Libre CRS	Lima		Peru	Lima 01
26	Lausanne Vaccine and Immunotherapy Center CRS	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Lawrence Corey, HVTN; FHCRC
• Study Chair: Myron Cohen, HPTN; University of North Carolina

Study Documents (Full-Text)

• Study Protocol - Jun 15, 2017
• Statistical Analysis Plan - Jul 7, 2020
• Informed Consent Form - Jun 15, 2017

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT02716675
• Other Study ID Numbers: HVTN 704/HPTN 085; 30095
• First Posted: Mar 23, 2016
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): HIV-1 Infections
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomly assigned to the placebo, low-dose VRC01, or high-dose VRC01 arm. The pooled VRC01 arm represents participants assigned to low-dose or high-dose VRC01 and is the primary comparison group for the primary analysis of prevention efficacy.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Period Title: Overall Study
STARTED	903	899	897
Modified Intent-to-treat Population	898	895	894
COMPLETED	703	702	686
NOT COMPLETED	200	197	211

Baseline Characteristics

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Total
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	Total of all reporting groups
Overall Participants	903	899	897	2699
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	28	28	27	28
Age, Customized (Count of Participants)
Less than 18 years	0 0%	0 0%	0 0%	0 0%
18 - 20 years	95 10.5%	94 10.5%	106 11.8%	295 10.9%
21 - 30 years	496 54.9%	474 52.7%	480 53.5%	1450 53.7%
31 - 40 years	232 25.7%	253 28.1%	208 23.2%	693 25.7%
41 - 50 years	80 8.9%	77 8.6%	103 11.5%	260 9.6%
Above 50 years	0 0%	1 0.1%	0 0%	1 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	11 1.2%	7 0.8%	8 0.9%	26 1%
Male	892 98.8%	892 99.2%	889 99.1%	2673 99%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	532 58.9%	517 57.5%	495 55.2%	1544 57.2%
Not Hispanic or Latino	371 41.1%	382 42.5%	402 44.8%	1155 42.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 0.7%	7 0.8%	3 0.3%	16 0.6%
Asian	22 2.4%	29 3.2%	18 2%	69 2.6%
Native Hawaiian or Other Pacific Islander	4 0.4%	2 0.2%	2 0.2%	8 0.3%
Black or African American	132 14.6%	132 14.7%	144 16.1%	408 15.1%
White	286 31.7%	272 30.3%	293 32.7%	851 31.5%
More than one race	32 3.5%	32 3.6%	24 2.7%	88 3.3%
Unknown or Not Reported	421 46.6%	425 47.3%	413 46%	1259 46.6%
Region of Enrollment (Count of Participants)
United States	460 50.9%	464 51.6%	457 50.9%	1381 51.2%
Brazil	51 5.6%	49 5.5%	51 5.7%	151 5.6%
Peru	380 42.1%	374 41.6%	377 42%	1131 41.9%
Switzerland	12 1.3%	12 1.3%	12 1.3%	36 1.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Description	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
Time Frame	Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
None	812 89.9%	794 88.3%	805 89.7%	1599 59.2%
Mild	90 10%	104 11.6%	88 9.8%	192 7.1%
Moderate	1 0.1%	1 0.1%	4 0.4%	5 0.2%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	754 83.5%	741 82.4%	759 84.6%	1500 55.6%
Mild	145 16.1%	153 17%	133 14.8%	286 10.6%
Moderate	4 0.4%	5 0.6%	5 0.6%	10 0.4%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	718 79.5%	702 78.1%	720 80.3%	1422 52.7%
Mild	180 19.9%	191 21.2%	170 19%	361 13.4%
Moderate	5 0.6%	6 0.7%	7 0.8%	13 0.5%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Description	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
Time Frame	Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
None	877 97.1%	878 97.7%	882 98.3%	1760 65.2%
Gr 1: 2.5 to less than 5cm	17 1.9%	13 1.4%	13 1.4%	26 1%
Gr 2: 5 to less than 10cm	9 1%	8 0.9%	2 0.2%	10 0.4%
Gr 3: >= 10cm	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%
None	896 99.2%	894 99.4%	894 99.7%	1788 66.2%
Gr 1: 2.5 to less than 5cm	7 0.8%	4 0.4%	2 0.2%	6 0.2%
Gr 2: 5 to less than 10cm	0 0%	1 0.1%	1 0.1%	2 0.1%
Gr 3: >= 10cm	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%
None	874 96.8%	876 97.4%	880 98.1%	1756 65.1%
Gr 1: 2.5 to less than 5cm	20 2.2%	15 1.7%	14 1.6%	29 1.1%
Gr 2: 5 to less than 10cm	9 1%	8 0.9%	3 0.3%	11 0.4%
Gr 3: >= 10cm	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Description	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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time Frame	Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
None	664 73.5%	672 74.7%	691 77%	1363 50.5%
Mild	197 21.8%	182 20.2%	169 18.8%	351 13%
Moderate	39 4.3%	45 5%	36 4%	81 3%
Severe	3 0.3%	0 0%	1 0.1%	1 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	809 89.6%	802 89.2%	820 91.4%	1622 60.1%
Mild	81 9%	76 8.5%	61 6.8%	137 5.1%
Moderate	13 1.4%	21 2.3%	15 1.7%	36 1.3%
Severe	0 0%	0 0%	1 0.1%	1 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	728 80.6%	714 79.4%	731 81.5%	1445 53.5%
Mild	146 16.2%	147 16.4%	137 15.3%	284 10.5%
Moderate	28 3.1%	35 3.9%	29 3.2%	64 2.4%
Severe	1 0.1%	3 0.3%	0 0%	3 0.1%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	821 90.9%	814 90.5%	812 90.5%	1626 60.2%
Mild	74 8.2%	74 8.2%	77 8.6%	151 5.6%
Moderate	8 0.9%	10 1.1%	8 0.9%	18 0.7%
Severe	0 0%	1 0.1%	0 0%	1 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	889 98.4%	873 97.1%	881 98.2%	1754 65%
Mild	12 1.3%	24 2.7%	12 1.3%	36 1.3%
Moderate	2 0.2%	2 0.2%	4 0.4%	6 0.2%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	857 94.9%	843 93.8%	861 96%	1704 63.1%
Mild	41 4.5%	45 5%	29 3.2%	74 2.7%
Moderate	5 0.6%	11 1.2%	6 0.7%	17 0.6%
Severe	0 0%	0 0%	1 0.1%	1 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	861 95.3%	848 94.3%	869 96.9%	1717 63.6%
Mild	39 4.3%	44 4.9%	21 2.3%	65 2.4%
Moderate	3 0.3%	7 0.8%	7 0.8%	14 0.5%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	556 61.6%	546 60.7%	563 62.8%	1109 41.1%
Mild	286 31.7%	277 30.8%	273 30.4%	550 20.4%
Moderate	57 6.3%	72 8%	59 6.6%	131 4.9%
Severe	4 0.4%	4 0.4%	2 0.2%	6 0.2%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%
None	880 97.5%	879 97.8%	870 97%	1749 64.8%
Mild	14 1.6%	11 1.2%	14 1.6%	25 0.9%
Moderate	7 0.8%	7 0.8%	12 1.3%	19 0.7%
Severe	1 0.1%	2 0.2%	1 0.1%	3 0.1%
Potentially Life-threatening	1 0.1%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
Description	For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame	Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
ALT (SGPT) (U/L)- Week 0	25	24	24	24
ALT (SGPT) (U/L)- Week 8	24	24	24	24
ALT (SGPT) (U/L)- Week 16	23	23	24	23
ALT (SGPT) (U/L)- Week 24	24	23	23	23
ALT (SGPT) (U/L)- Week 32	24	23	23	23
ALT (SGPT) (U/L)- Week 40	23	22	22	22
ALT (SGPT) (U/L)- Week 48	23	23	22	22
ALT (SGPT) (U/L)- Week 56	22	22	22	22
ALT (SGPT) (U/L)- Week 64	22	22	22	22
ALT (SGPT) (U/L)- Week 72	22	22	22	22

5. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Creatinine
Description	For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame	Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
Creatinine (mg/dL)- Week 0	0.86	0.86	0.86	0.86
Creatinine (mg/dL)- Week 8	0.87	0.86	0.88	0.87
Creatinine (mg/dL)- Week 16	0.88	0.87	0.87	0.87
Creatinine (mg/dL)- Week 24	0.87	0.88	0.88	0.88
Creatinine (mg/dL)- Week 32	0.88	0.87	0.87	0.87
Creatinine (mg/dL)- Week 40	0.88	0.88	0.88	0.88
Creatinine (mg/dL)- Week 48	0.88	0.89	0.89	0.89
Creatinine (mg/dL)- Week 56	0.88	0.89	0.88	0.88
Creatinine (mg/dL)- Week 64	0.88	0.89	0.89	0.89
Creatinine (mg/dL)- Week 72	0.89	0.88	0.89	0.89

6. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Hemoglobin
Description	For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame	Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
Hemoglobin (g/dL)- Week 0	14.9	14.8	14.9	14.8
Hemoglobin (g/dL)- Week 8	14.7	14.7	14.8	14.7
Hemoglobin (g/dL)- Week 16	14.7	14.7	14.7	14.7
Hemoglobin (g/dL)- Week 24	14.6	14.6	14.7	14.7
Hemoglobin (g/dL)- Week 32	14.6	14.6	14.7	14.6
Hemoglobin (g/dL)- Week 40	14.6	14.5	14.6	14.6
Hemoglobin (g/dL)- Week 48	14.6	14.6	14.6	14.6
Hemoglobin (g/dL)- Week 56	14.6	14.6	14.6	14.6
Hemoglobin (g/dL)- Week 64	14.6	14.5	14.6	14.5
Hemoglobin (g/dL)- Week 72	14.5	14.5	14.5	14.5

7. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Description	For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame	Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
Lymphocytes (cells/cubic mm)- Week 0	1988.5	1980	1971	1978.5
Lymphocytes (cells/cubic mm)- Week 8	1926	1904	1947.5	1930
Lymphocytes (cells/cubic mm)- Week 16	1927.5	1896	1915.5	1900.5
Lymphocytes (cells/cubic mm)- Week 24	1950	1925	1911	1920
Lymphocytes (cells/cubic mm)- Week 32	1957	1930	1900	1920
Lymphocytes (cells/cubic mm)- Week 40	1890	1900	1879	1890
Lymphocytes (cells/cubic mm)- Week 48	1923.5	1923	1870	1900
Lymphocytes (cells/cubic mm)- Week 56	1910	1887.5	1900.5	1895.5
Lymphocytes (cells/cubic mm)- Week 64	1922	1890	1870	1880
Lymphocytes (cells/cubic mm)- Week 72	1940	1930	1900	1910
Neutrophils (cells/cubic mm)- Week 0	3586	3593	3534	3571.5
Neutrophils (cells/cubic mm)- Week 8	3410	3460	3424	3437
Neutrophils (cells/cubic mm)- Week 16	3378	3377	3360	3361.5
Neutrophils (cells/cubic mm)- Week 24	3330	3417	3306	3357.5
Neutrophils (cells/cubic mm)- Week 32	3344	3360	3336	3350
Neutrophils (cells/cubic mm)- Week 40	3310	3260	3300	3287
Neutrophils (cells/cubic mm)- Week 48	3322	3284.5	3266.5	3278
Neutrophils (cells/cubic mm)- Week 56	3340	3238.5	3200	3212.5
Neutrophils (cells/cubic mm)- Week 64	3245	3240	3228	3230
Neutrophils (cells/cubic mm)- Week 72	3286.5	3245	3304	3272

8. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Description	For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time Frame	Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
WBC (1000 cells/cubic mm)- Week 0	6.33	6.4	6.3	6.3
WBC (1000 cells/cubic mm)- Week 8	6.2	6.1	6.2	6.12
WBC (1000 cells/cubic mm)- Week 16	6.1	6.1	6.1	6.1
WBC (1000 cells/cubic mm)- Week 24	6.1	6.15	6.05	6.1
WBC (1000 cells/cubic mm)- Week 32	6.1	6.1	6.05	6.1
WBC (1000 cells/cubic mm)- Week 40	6.09	6.09	5.95	6
WBC (1000 cells/cubic mm)- Week 48	6.16	6	6	6
WBC (1000 cells/cubic mm)- Week 56	6.1	6.04	5.9	6
WBC (1000 cells/cubic mm)- Week 64	6.05	5.9	5.95	5.94
WBC (1000 cells/cubic mm)- Week 72	5.91	5.92	6.05	6
Platelets (1000 cells/cubic mm)- Week 0	248.5	248	249	248.1
Platelets (1000 cells/cubic mm)- Week 8	248	250	248	249
Platelets (1000 cells/cubic mm)- Week 16	249.5	252	251	251
Platelets (1000 cells/cubic mm)- Week 24	251.5	250	251	250.5
Platelets (1000 cells/cubic mm)- Week 32	252	253.5	250	252
Platelets (1000 cells/cubic mm)- Week 40	250.7	254.5	250	252
Platelets (1000 cells/cubic mm)- Week 48	251	256	251	253
Platelets (1000 cells/cubic mm)- Week 56	254	256	251	253
Platelets (1000 cells/cubic mm)- Week 64	254	256	249	252
Platelets (1000 cells/cubic mm)- Week 72	254	253	253	253

9. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Description	The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1.
Time Frame	Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72.

Outcome Measure Data

Analysis Population Description

Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
ALT (SGPT) (U/L)- Week 8	1 0.1%	0 0%	1 0.1%	1 0%
ALT (SGPT) (U/L)- Week 16	1 0.1%	0 0%	4 0.4%	4 0.1%
ALT (SGPT) (U/L)- Week 24	3 0.3%	2 0.2%	2 0.2%	4 0.1%
ALT (SGPT) (U/L)- Week 32	2 0.2%	1 0.1%	1 0.1%	2 0.1%
ALT (SGPT) (U/L)- Week 40	0 0%	2 0.2%	1 0.1%	3 0.1%
ALT (SGPT) (U/L)- Week 48	4 0.4%	0 0%	1 0.1%	1 0%
ALT (SGPT) (U/L)- Week 56	1 0.1%	4 0.4%	3 0.3%	7 0.3%
ALT (SGPT) (U/L)- Week 64	3 0.3%	2 0.2%	1 0.1%	3 0.1%
ALT (SGPT) (U/L)- Week 72	1 0.1%	3 0.3%	0 0%	3 0.1%
Hemoglobin (g/dL)- Week 8	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 16	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 24	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 32	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 40	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 48	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 56	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 64	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Week 72	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- Week 8	7 0.8%	1 0.1%	2 0.2%	3 0.1%
Creatinine (mg/dL)- Week 16	3 0.3%	3 0.3%	3 0.3%	6 0.2%
Creatinine (mg/dL)- Week 24	6 0.7%	3 0.3%	2 0.2%	5 0.2%
Creatinine (mg/dL)- Week 32	4 0.4%	3 0.3%	5 0.6%	8 0.3%
Creatinine (mg/dL)- Week 40	5 0.6%	7 0.8%	6 0.7%	13 0.5%
Creatinine (mg/dL)- Week 48	3 0.3%	3 0.3%	1 0.1%	4 0.1%
Creatinine (mg/dL)- Week 56	5 0.6%	4 0.4%	2 0.2%	6 0.2%
Creatinine (mg/dL)- Week 64	3 0.3%	5 0.6%	2 0.2%	7 0.3%
Creatinine (mg/dL)- Week 72	4 0.4%	4 0.4%	2 0.2%	6 0.2%
WBC (1000/cubic mm)- Week 8	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 16	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 24	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 32	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 40	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 48	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 56	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 64	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Week 72	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 8	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 16	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 24	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 32	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 40	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 48	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 56	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 64	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Week 72	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 8	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 16	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 24	1 0.1%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 32	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 40	0 0%	0 0%	1 0.1%	1 0%
Lymphocytes (cells/cubic mm)- Week 48	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 56	1 0.1%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 64	0 0%	0 0%	0 0%	0 0%
Lymphocytes (cells/cubic mm)- Week 72	0 0%	0 0%	0 0%	0 0%
Neutrophils (cells/cubic mm)- Week 8	0 0%	1 0.1%	0 0%	1 0%
Neutrophils (cells/cubic mm)- Week 16	0 0%	1 0.1%	0 0%	1 0%
Neutrophils (cells/cubic mm)- Week 24	0 0%	0 0%	0 0%	0 0%
Neutrophils (cells/cubic mm)- Week 32	0 0%	0 0%	0 0%	0 0%
Neutrophils (cells/cubic mm)- Week 40	0 0%	1 0.1%	0 0%	1 0%
Neutrophils (cells/cubic mm)- Week 48	0 0%	0 0%	0 0%	0 0%
Neutrophils (cells/cubic mm)- Week 56	0 0%	1 0.1%	0 0%	1 0%
Neutrophils (cells/cubic mm)- Week 64	0 0%	0 0%	0 0%	0 0%
Neutrophils (cells/cubic mm)- Week 72	0 0%	0 0%	0 0%	0 0%

10. Primary Outcome

Title	Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Description	The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form.
Time Frame	Measured through Week 72 (the last infusion visit).

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897	1796
Pregnancy	0 0%	0 0%	0 0%	0 0%
HIV infection	37 4.1%	32 3.6%	21 2.3%	53 2%
Death	0 0%	2 0.2%	0 0%	2 0.1%
Clinical event other than reactogenicity	14 1.6%	16 1.8%	20 2.2%	36 1.3%
Reactogenicity Symptom	0 0%	0 0%	0 0%	0 0%
Investigator Reason	7 0.8%	2 0.2%	1 0.1%	3 0.1%
Participant refused study product infusion	5 0.6%	5 0.6%	7 0.8%	12 0.4%
Co-enrollment in a study	1 0.1%	2 0.2%	1 0.1%	3 0.1%
Two(2) reactive HIV tests	0 0%	0 0%	3 0.3%	3 0.1%
Other	11 1.2%	6 0.7%	7 0.8%	13 0.5%
Termination from study for non-medical reason(s)	69 7.6%	75 8.3%	80 8.9%	155 5.7%
No Discontinuation	759 84.1%	759 84.4%	757 84.4%	1516 56.2%

11. Primary Outcome

Title	Incidence Rate of Early Infusion Discontinuation
Description	Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored.
Time Frame	Measured through Week 72 (the last infusion visit).

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	903	899	897
Number (95% Confidence Interval) [events per 100 person years]	8.9	10	8.8

12. Primary Outcome

Title	Number of Participants With Documented HIV-1 Infection by the Week 80 Visit
Description	Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial.
Time Frame	Measured through Week 80.

Outcome Measure Data

Analysis Population Description

MITT population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	898	895	894	1789
Count of Participants [Participants]	38 4.2%	32 3.6%	28 3.1%	60 2.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pooled VRC01
	Comments	The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments	The threshold for statistical significance was p = 0.05.
	Method	wald
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	26.6
	Confidence Interval	(2-Sided) 95%; -11.7 to 51.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Low-Dose VRC01
	Comments	A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	22.4
	Confidence Interval	(2-Sided) 95%; -25.5 to 52.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, High-Dose VRC01
	Comments	A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	30.9
	Confidence Interval	(2-Sided) 95%; -13.9 to 58.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
Description	The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals.
Time Frame	Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.

Outcome Measure Data

Analysis Population Description

Pilot study population

Arm/Group Title	Low-Dose VRC01	High-Dose VRC01
Arm/Group Description	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	12	12
4-week post infusion visit	23.1	55.1
8-week post infusion visit	5.8	15.4
Day 61	65.7	212

14. Secondary Outcome

Title	VRC01 Clinical Lot Neutralization of Founder Viruses (IC80)
Description	The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or >3 μg per milliliter) with the use of the Aalen-Johansen estimator.
Time Frame	Measured through Week 80.

Outcome Measure Data

Analysis Population Description

MITT population

Arm/Group Title	Placebo	Low-Dose VRC01	High-Dose VRC01	Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	898	895	894	1789
Median (Inter-Quartile Range) [μg/ml]	3.28	4.7	5.78	4.97

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pooled VRC01
	Comments	PE against IC80 of least sensitive variant less than 1
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	73
	Confidence Interval	(2-Sided) 95%; 27.6 to 89.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pooled VRC01
	Comments	PE against IC80 of least sensitive variant 1-3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	6.1
	Confidence Interval	(2-Sided) 95%; -174.3 to 67.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pooled VRC01
	Comments	PE against IC80 of least sensitive variant > 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Prevention Efficacy (PE)
	Estimated Value	8.6
	Confidence Interval	(2-Sided) 95%; -68.1 to 50.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
Description	Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm.
Time Frame	First RNA+ Sample detected from baseline up to Week 104.

Outcome Measure Data

Analysis Population Description

Subset of HIV-infected VRC01 recipients

Arm/Group Title	Pooled VRC01
Arm/Group Description	VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Measure Participants	31
ID50	NA
ID80	NA

Adverse Events

Time Frame	The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
Arm/Group Title	Placebo		Low-Dose VRC01		High-Dose VRC01		Pooled VRC01
Arm/Group Description	Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.		VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.		VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.		VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
All Cause Mortality
	Placebo		Low-Dose VRC01		High-Dose VRC01		Pooled VRC01
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/903 (0.2%)		3/899 (0.3%)		0/897 (0%)		3/1796 (0.2%)
Serious Adverse Events
	Placebo		Low-Dose VRC01		High-Dose VRC01		Pooled VRC01
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/903 (3.5%)		35/899 (3.9%)		32/897 (3.6%)		67/1796 (3.7%)
Cardiac disorders
Any Event in SOC	1/903 (0.1%)	1	0/899 (0%)	0	3/897 (0.3%)	4	3/1796 (0.2%)	4
Angina unstable	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Atrial fibrillation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Coronary artery occlusion	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Myocardial infarction	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Myocardial ischaemia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Gastrointestinal disorders
Any Event in SOC	3/903 (0.3%)	6	0/899 (0%)	0	4/897 (0.4%)	5	4/1796 (0.2%)	5
Abdominal pain upper	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Diarrhoea	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Enterocolitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Gastrointestinal haemorrhage	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Gastrooesophageal reflux disease	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Incarcerated inguinal hernia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Large intestine perforation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nausea	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Pancreatitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Vomiting	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
General disorders
Any Event in SOC	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Non-cardiac chest pain	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Hepatobiliary disorders
Any Event in SOC	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Cholecystitis acute	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Cholecystitis chronic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Infections and infestations
Any Event in SOC	10/903 (1.1%)	10	14/899 (1.6%)	15	10/897 (1.1%)	10	24/1796 (1.3%)	25
Abscess limb	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anal abscess	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Appendicitis	4/903 (0.4%)	4	5/899 (0.6%)	5	3/897 (0.3%)	3	8/1796 (0.4%)	8
COVID-19	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cellulitis	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Endocarditis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Febrile infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Gastroenteritis salmonella	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Injection site cellulitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lung abscess	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Oral herpes	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Pneumonia	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Pneumonia bacterial	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Pyelonephritis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Shigella infection	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Tuberculous pleurisy	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Varicella	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Injury, poisoning and procedural complications
Any Event in SOC	5/903 (0.6%)	8	7/899 (0.8%)	8	2/897 (0.2%)	2	9/1796 (0.5%)	10
Abdominal injury	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Alcohol poisoning	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Contusion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Femur fracture	1/903 (0.1%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Lower limb fracture	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Multiple fractures	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Multiple injuries	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Skin laceration	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tendon rupture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Thermal burn	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tibia fracture	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Toxicity to various agents	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Ulna fracture	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Upper limb fracture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Investigations
Any Event in SOC	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Platelet count decreased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Metabolism and nutrition disorders
Any Event in SOC	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hypernatraemia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hyponatraemia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Musculoskeletal and connective tissue disorders
Any Event in SOC	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Osteopenia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Anogenital warts	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Colon cancer metastatic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Nervous system disorders
Any Event in SOC	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Radial nerve palsy	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Syncope	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Psychiatric disorders
Any Event in SOC	10/903 (1.1%)	18	8/899 (0.9%)	10	12/897 (1.3%)	15	20/1796 (1.1%)	25
Alcoholism	2/903 (0.2%)	3	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anxiety	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Bipolar I disorder	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Bipolar disorder	1/903 (0.1%)	1	2/899 (0.2%)	3	3/897 (0.3%)	4	5/1796 (0.3%)	7
Completed suicide	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Depression	1/903 (0.1%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Emotional distress	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hallucination, auditory	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Major depression	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Mania	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Psychotic disorder	2/903 (0.2%)	3	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Substance dependence	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Substance-induced psychotic disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Suicidal ideation	1/903 (0.1%)	1	1/899 (0.1%)	1	4/897 (0.4%)	4	5/1796 (0.3%)	5
Suicide attempt	4/903 (0.4%)	6	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Renal and urinary disorders
Any Event in SOC	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Nephrolithiasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	0/903 (0%)	0	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Pneumomediastinum	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pneumonia aspiration	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pneumothorax spontaneous	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Low-Dose VRC01		High-Dose VRC01		Pooled VRC01
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	750/903 (83.1%)		771/899 (85.8%)		742/897 (82.7%)		1513/1796 (84.2%)
Blood and lymphatic system disorders
Any Event in SOC	17/903 (1.9%)	18	26/899 (2.9%)	28	23/897 (2.6%)	29	49/1796 (2.7%)	57
Anaemia	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Iron deficiency anaemia	2/903 (0.2%)	2	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Leukopenia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lymphadenitis	2/903 (0.2%)	2	0/899 (0%)	0	2/897 (0.2%)	3	2/1796 (0.1%)	3
Lymphadenopathy	11/903 (1.2%)	12	15/899 (1.7%)	16	14/897 (1.6%)	17	29/1796 (1.6%)	33
Lymphopenia	2/903 (0.2%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Microcytic anaemia	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Microcytosis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Neutropenia	0/903 (0%)	0	3/899 (0.3%)	3	5/897 (0.6%)	6	8/1796 (0.4%)	9
Splenomegaly	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Thrombocytopenia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cardiac disorders
Any Event in SOC	7/903 (0.8%)	8	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Atrioventricular block second degree	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Brugada syndrome	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Intracardiac mass	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Palpitations	3/903 (0.3%)	3	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Postural orthostatic tachycardia syndrome	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Sinus tachycardia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tachycardia	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Congenital, familial and genetic disorders
Any Event in SOC	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Dermoid cyst	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Encephalocele	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Frenulum breve	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypertrophic cardiomyopathy	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tourette's disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Ear and labyrinth disorders
Any Event in SOC	12/903 (1.3%)	12	17/899 (1.9%)	19	5/897 (0.6%)	5	22/1796 (1.2%)	24
Cerumen impaction	0/903 (0%)	0	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Deafness unilateral	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ear discomfort	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Ear pain	2/903 (0.2%)	2	7/899 (0.8%)	7	1/897 (0.1%)	1	8/1796 (0.4%)	8
Ear pruritus	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Motion sickness	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Tinnitus	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Tympanic membrane hyperaemia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tympanic membrane perforation	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Vertigo	5/903 (0.6%)	5	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Vertigo positional	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Endocrine disorders
Any Event in SOC	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hypothyroidism	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eye disorders
Any Event in SOC	14/903 (1.6%)	14	11/899 (1.2%)	12	8/897 (0.9%)	8	19/1796 (1.1%)	20
Blepharitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Blepharospasm	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cataract	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Chalazion	2/903 (0.2%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Conjunctival haemorrhage	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Conjunctival hyperaemia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Conjunctivitis allergic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Diplopia	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dry eye	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Erythema of eyelid	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eye inflammation	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eye irritation	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Eye pain	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Eye pruritus	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Eye swelling	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Keratitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Keratoconus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lacrimation increased	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lagophthalmos	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Macular degeneration	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ocular hyperaemia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Retinal detachment	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Scintillating scotoma	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Strabismus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Swelling of eyelid	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Vision blurred	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastrointestinal disorders
Any Event in SOC	155/903 (17.2%)	211	183/899 (20.4%)	269	175/897 (19.5%)	253	358/1796 (19.9%)	522
Abdominal discomfort	4/903 (0.4%)	4	1/899 (0.1%)	1	7/897 (0.8%)	7	8/1796 (0.4%)	8
Abdominal distension	2/903 (0.2%)	2	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Abdominal hernia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Abdominal pain	8/903 (0.9%)	9	8/899 (0.9%)	8	11/897 (1.2%)	11	19/1796 (1.1%)	19
Abdominal pain lower	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Abdominal pain upper	3/903 (0.3%)	3	5/899 (0.6%)	5	4/897 (0.4%)	4	9/1796 (0.5%)	9
Acquired oesophageal web	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Anal fissure	4/903 (0.4%)	5	10/899 (1.1%)	12	8/897 (0.9%)	8	18/1796 (1%)	20
Anal fistula	1/903 (0.1%)	1	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Anal haemorrhage	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Anal pruritus	8/903 (0.9%)	8	3/899 (0.3%)	4	3/897 (0.3%)	3	6/1796 (0.3%)	7
Anal skin tags	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Anal ulcer	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Anorectal discomfort	2/903 (0.2%)	2	1/899 (0.1%)	1	3/897 (0.3%)	3	4/1796 (0.2%)	4
Aphthous ulcer	5/903 (0.6%)	5	5/899 (0.6%)	5	2/897 (0.2%)	2	7/1796 (0.4%)	7
Chapped lips	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Chronic gastritis	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Coeliac disease	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Colitis	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Constipation	5/903 (0.6%)	5	4/899 (0.4%)	5	5/897 (0.6%)	6	9/1796 (0.5%)	11
Defaecation urgency	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dental caries	1/903 (0.1%)	2	4/899 (0.4%)	4	6/897 (0.7%)	7	10/1796 (0.6%)	11
Diarrhoea	57/903 (6.3%)	64	49/899 (5.5%)	62	58/897 (6.5%)	66	107/1796 (6%)	128
Diverticulum intestinal	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dyschezia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dyspepsia	5/903 (0.6%)	5	3/899 (0.3%)	3	9/897 (1%)	9	12/1796 (0.7%)	12
Dysphagia	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Enteritis	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Enterocolitis	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Epigastric discomfort	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Erosive oesophagitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Faeces discoloured	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Flatulence	3/903 (0.3%)	3	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Food poisoning	12/903 (1.3%)	12	18/899 (2%)	18	15/897 (1.7%)	16	33/1796 (1.8%)	34
Frequent bowel movements	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Gastric ulcer	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Gastritis	5/903 (0.6%)	5	5/899 (0.6%)	6	4/897 (0.4%)	4	9/1796 (0.5%)	10
Gastrointestinal disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastrointestinal motility disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastrointestinal pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastrooesophageal reflux disease	6/903 (0.7%)	9	5/899 (0.6%)	5	10/897 (1.1%)	10	15/1796 (0.8%)	15
Gingival pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gingival recession	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Gingival swelling	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Haematochezia	0/903 (0%)	0	1/899 (0.1%)	1	3/897 (0.3%)	3	4/1796 (0.2%)	4
Haemorrhoidal haemorrhage	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Haemorrhoids	11/903 (1.2%)	11	21/899 (2.3%)	23	10/897 (1.1%)	10	31/1796 (1.7%)	33
Haemorrhoids thrombosed	1/903 (0.1%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Hiatus hernia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypertrophy of tongue papillae	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Inguinal hernia	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Irritable bowel syndrome	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Large intestine polyp	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lip erosion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lip swelling	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lip ulceration	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Malpositioned teeth	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Mouth cyst	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Mouth haemorrhage	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Mouth ulceration	0/903 (0%)	0	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Nausea	10/903 (1.1%)	10	18/899 (2%)	19	16/897 (1.8%)	18	34/1796 (1.9%)	37
Noninfective gingivitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Odynophagia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Oesophageal ulcer	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Oesophagitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Oral disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Oral pain	1/903 (0.1%)	1	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Oral papule	0/903 (0%)	0	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Paraesthesia oral	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Post-tussive vomiting	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Proctalgia	3/903 (0.3%)	3	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Proctitis	5/903 (0.6%)	6	8/899 (0.9%)	11	8/897 (0.9%)	9	16/1796 (0.9%)	20
Proctitis ulcerative	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Rectal discharge	1/903 (0.1%)	1	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Rectal fissure	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Rectal haemorrhage	4/903 (0.4%)	4	6/899 (0.7%)	6	2/897 (0.2%)	2	8/1796 (0.4%)	8
Rectal prolapse	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Salivary gland pain	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Stomatitis	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Swollen tongue	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tongue discomfort	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Tongue ulceration	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Tooth demineralisation	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tooth impacted	2/903 (0.2%)	2	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Toothache	6/903 (0.7%)	6	8/899 (0.9%)	9	10/897 (1.1%)	10	18/1796 (1%)	19
Vomiting	4/903 (0.4%)	4	7/899 (0.8%)	7	4/897 (0.4%)	4	11/1796 (0.6%)	11
General disorders
Any Event in SOC	65/903 (7.2%)	77	88/899 (9.8%)	106	80/897 (8.9%)	93	168/1796 (9.4%)	199
Adverse drug reaction	4/903 (0.4%)	4	4/899 (0.4%)	4	7/897 (0.8%)	7	11/1796 (0.6%)	11
Adverse food reaction	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Asthenia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Axillary pain	1/903 (0.1%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Chest discomfort	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Chest pain	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Chills	2/903 (0.2%)	2	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Cyst	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Drug withdrawal syndrome	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Early satiety	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Fatigue	11/903 (1.2%)	11	13/899 (1.4%)	13	12/897 (1.3%)	13	25/1796 (1.4%)	26
Feeling hot	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Hangover	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Induration	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Influenza like illness	37/903 (4.1%)	38	36/899 (4%)	39	36/897 (4%)	39	72/1796 (4%)	78
Infusion site bruising	0/903 (0%)	0	3/899 (0.3%)	5	1/897 (0.1%)	1	4/1796 (0.2%)	6
Infusion site extravasation	3/903 (0.3%)	3	7/899 (0.8%)	7	2/897 (0.2%)	2	9/1796 (0.5%)	9
Infusion site irritation	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Infusion site pruritus	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Injection site bruising	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Injection site pain	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Injection site pruritus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Injection site reaction	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Injury associated with device	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lithiasis	1/903 (0.1%)	1	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Malaise	0/903 (0%)	0	4/899 (0.4%)	4	1/897 (0.1%)	1	5/1796 (0.3%)	5
Nodule	0/903 (0%)	0	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Non-cardiac chest pain	1/903 (0.1%)	1	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Oedema peripheral	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Pain	0/903 (0%)	0	4/899 (0.4%)	4	2/897 (0.2%)	2	6/1796 (0.3%)	6
Peripheral swelling	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Puncture site pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pyrexia	5/903 (0.6%)	5	8/899 (0.9%)	8	4/897 (0.4%)	4	12/1796 (0.7%)	12
Swelling	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Temperature intolerance	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ulcer	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Vessel puncture site bruise	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Vessel puncture site pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Xerosis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hepatobiliary disorders
Any Event in SOC	5/903 (0.6%)	5	7/899 (0.8%)	8	2/897 (0.2%)	3	9/1796 (0.5%)	11
Biliary colic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cholecystitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cholelithiasis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Deficiency of bile secretion	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Drug-induced liver injury	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gallbladder polyp	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Hepatic lesion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hepatic steatosis	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Hepatitis acute	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Jaundice	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Non-alcoholic steatohepatitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Immune system disorders
Any Event in SOC	23/903 (2.5%)	25	19/899 (2.1%)	20	12/897 (1.3%)	13	31/1796 (1.7%)	33
Anaphylactic reaction	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Drug hypersensitivity	4/903 (0.4%)	5	0/899 (0%)	0	3/897 (0.3%)	3	3/1796 (0.2%)	3
Food allergy	4/903 (0.4%)	5	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Hypersensitivity	3/903 (0.3%)	3	5/899 (0.6%)	5	1/897 (0.1%)	1	6/1796 (0.3%)	6
Jarisch-Herxheimer reaction	0/903 (0%)	0	1/899 (0.1%)	2	1/897 (0.1%)	1	2/1796 (0.1%)	3
Mite allergy	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Multiple allergies	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Seasonal allergy	10/903 (1.1%)	10	9/899 (1%)	9	6/897 (0.7%)	6	15/1796 (0.8%)	15
Infections and infestations
Any Event in SOC	591/903 (65.4%)	1612	612/899 (68.1%)	1732	585/897 (65.2%)	1669	1197/1796 (66.6%)	3401
Abdominal abscess	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Abscess limb	6/903 (0.7%)	6	5/899 (0.6%)	5	6/897 (0.7%)	6	11/1796 (0.6%)	11
Abscess neck	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Acariasis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Acarodermatitis	19/903 (2.1%)	20	18/899 (2%)	21	17/897 (1.9%)	19	35/1796 (1.9%)	40
Acute hepatitis B	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Acute hepatitis C	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Acute sinusitis	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Amoebic dysentery	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Anal abscess	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Anal chlamydia infection	162/903 (17.9%)	211	176/899 (19.6%)	244	187/897 (20.8%)	244	363/1796 (20.2%)	488
Anal fistula infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anal fungal infection	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Anal infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anorectal human papilloma virus infection	1/903 (0.1%)	2	2/899 (0.2%)	2	4/897 (0.4%)	4	6/1796 (0.3%)	6
Anorectal infection	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Ascariasis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Bacterial colitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Bacterial infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Bacterial vaginosis	2/903 (0.2%)	2	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Balanitis candida	3/903 (0.3%)	6	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Blastocystis infection	2/903 (0.2%)	3	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Body tinea	8/903 (0.9%)	9	3/899 (0.3%)	3	7/897 (0.8%)	7	10/1796 (0.6%)	10
Bronchiolitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Bronchitis	12/903 (1.3%)	13	14/899 (1.6%)	14	12/897 (1.3%)	13	26/1796 (1.4%)	27
Bronchitis bacterial	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Bronchitis viral	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Burn infection	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
COVID-19	3/903 (0.3%)	3	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Campylobacter gastroenteritis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Cellulitis	7/903 (0.8%)	9	3/899 (0.3%)	3	6/897 (0.7%)	6	9/1796 (0.5%)	9
Cellulitis of male external genital organ	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Cestode infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Chancroid	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Chlamydial infection	9/903 (1%)	12	4/899 (0.4%)	4	10/897 (1.1%)	12	14/1796 (0.8%)	16
Cholera	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Chronic hepatitis C	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Chronic sinusitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Clostridium difficile infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Conjunctivitis	6/903 (0.7%)	6	11/899 (1.2%)	11	11/897 (1.2%)	11	22/1796 (1.2%)	22
Conjunctivitis bacterial	5/903 (0.6%)	5	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Conjunctivitis viral	2/903 (0.2%)	2	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Coxsackie viral infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Cystitis	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Cytomegalovirus colitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dermatophytosis	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dermatophytosis of nail	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Diarrhoea infectious	5/903 (0.6%)	5	2/899 (0.2%)	2	4/897 (0.4%)	4	6/1796 (0.3%)	6
Diverticulitis	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dysentery	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Ear infection	3/903 (0.3%)	3	3/899 (0.3%)	3	4/897 (0.4%)	6	7/1796 (0.4%)	9
Ear infection bacterial	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Enterobiasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Epididymitis	4/903 (0.4%)	4	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Erythema migrans	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Escherichia urinary tract infection	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eyelid infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Febrile infection	5/903 (0.6%)	5	4/899 (0.4%)	4	3/897 (0.3%)	3	7/1796 (0.4%)	7
Folliculitis	12/903 (1.3%)	12	10/899 (1.1%)	10	9/897 (1%)	9	19/1796 (1.1%)	19
Fungal balanitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Fungal infection	4/903 (0.4%)	4	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Fungal skin infection	2/903 (0.2%)	2	4/899 (0.4%)	4	5/897 (0.6%)	5	9/1796 (0.5%)	9
Furuncle	2/903 (0.2%)	2	1/899 (0.1%)	1	4/897 (0.4%)	5	5/1796 (0.3%)	6
Gastroenteritis	48/903 (5.3%)	53	43/899 (4.8%)	49	38/897 (4.2%)	44	81/1796 (4.5%)	93
Gastroenteritis Escherichia coli	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastroenteritis bacterial	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastroenteritis viral	2/903 (0.2%)	2	12/899 (1.3%)	12	4/897 (0.4%)	4	16/1796 (0.9%)	16
Gastrointestinal bacterial overgrowth	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Gastrointestinal infection	7/903 (0.8%)	8	7/899 (0.8%)	9	11/897 (1.2%)	14	18/1796 (1%)	23
Gastrointestinal viral infection	1/903 (0.1%)	1	2/899 (0.2%)	3	0/897 (0%)	0	2/1796 (0.1%)	3
Genital candidiasis	2/903 (0.2%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Genital herpes	8/903 (0.9%)	8	13/899 (1.4%)	16	10/897 (1.1%)	10	23/1796 (1.3%)	26
Genital herpes simplex	5/903 (0.6%)	5	4/899 (0.4%)	4	4/897 (0.4%)	4	8/1796 (0.4%)	8
Genitourinary chlamydia infection	50/903 (5.5%)	54	46/899 (5.1%)	54	43/897 (4.8%)	46	89/1796 (5%)	100
Genitourinary tract gonococcal infection	35/903 (3.9%)	37	35/899 (3.9%)	42	36/897 (4%)	37	71/1796 (4%)	79
Giardiasis	3/903 (0.3%)	3	3/899 (0.3%)	4	4/897 (0.4%)	4	7/1796 (0.4%)	8
Gingival abscess	0/903 (0%)	0	1/899 (0.1%)	2	1/897 (0.1%)	1	2/1796 (0.1%)	3
Gingivitis	4/903 (0.4%)	4	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Gonococcal infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Gonorrhoea	6/903 (0.7%)	6	4/899 (0.4%)	4	7/897 (0.8%)	7	11/1796 (0.6%)	11
Groin abscess	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hand-foot-and-mouth disease	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Helicobacter gastritis	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Helicobacter infection	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hepatitis A	0/903 (0%)	0	6/899 (0.7%)	6	0/897 (0%)	0	6/1796 (0.3%)	6
Hepatitis C	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hepatitis viral	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Herpes simplex	1/903 (0.1%)	1	4/899 (0.4%)	4	9/897 (1%)	11	13/1796 (0.7%)	15
Herpes virus infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Herpes zoster	2/903 (0.2%)	2	3/899 (0.3%)	5	1/897 (0.1%)	1	4/1796 (0.2%)	6
Hordeolum	7/903 (0.8%)	7	8/899 (0.9%)	14	6/897 (0.7%)	6	14/1796 (0.8%)	20
Impetigo	2/903 (0.2%)	2	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Infected bite	1/903 (0.1%)	1	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Infection parasitic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Infectious mononucleosis	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Infective corneal ulcer	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Influenza	17/903 (1.9%)	17	16/899 (1.8%)	17	11/897 (1.2%)	12	27/1796 (1.5%)	29
Labyrinthitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Laryngitis	3/903 (0.3%)	4	1/899 (0.1%)	1	4/897 (0.4%)	5	5/1796 (0.3%)	6
Latent syphilis	20/903 (2.2%)	21	25/899 (2.8%)	28	19/897 (2.1%)	20	44/1796 (2.4%)	48
Latent tuberculosis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lice infestation	2/903 (0.2%)	2	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Localised infection	2/903 (0.2%)	2	0/899 (0%)	0	3/897 (0.3%)	3	3/1796 (0.2%)	3
Lower respiratory tract infection	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lower respiratory tract infection viral	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lymphadenitis bacterial	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lymphangitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lymphogranuloma venereum	1/903 (0.1%)	1	3/899 (0.3%)	3	5/897 (0.6%)	5	8/1796 (0.4%)	8
Molluscum contagiosum	0/903 (0%)	0	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Nasal herpes	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Nasopharyngitis	53/903 (5.9%)	65	55/899 (6.1%)	75	51/897 (5.7%)	72	106/1796 (5.9%)	147
Neurosyphilis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Nipple infection	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Oesophageal candidiasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Omphalitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Onychomycosis	3/903 (0.3%)	3	6/899 (0.7%)	6	3/897 (0.3%)	3	9/1796 (0.5%)	9
Oral candidiasis	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Oral herpes	10/903 (1.1%)	11	8/899 (0.9%)	8	6/897 (0.7%)	6	14/1796 (0.8%)	14
Oral pustule	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Orchitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Oropharyngeal candidiasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Oropharyngeal gonococcal infection	51/903 (5.6%)	61	65/899 (7.2%)	77	69/897 (7.7%)	79	134/1796 (7.5%)	156
Otitis externa	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Otitis media	4/903 (0.4%)	4	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Otitis media acute	0/903 (0%)	0	3/899 (0.3%)	3	4/897 (0.4%)	4	7/1796 (0.4%)	7
Papilloma viral infection	1/903 (0.1%)	2	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Parasitic gastroenteritis	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Paronychia	2/903 (0.2%)	3	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Parotitis	4/903 (0.4%)	4	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Penile abscess	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Penile infection	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pericoronitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Periodontitis	3/903 (0.3%)	3	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Perirectal abscess	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Pharyngeal chlamydia infection	11/903 (1.2%)	11	12/899 (1.3%)	14	6/897 (0.7%)	8	18/1796 (1%)	22
Pharyngitis	31/903 (3.4%)	34	25/899 (2.8%)	26	26/897 (2.9%)	31	51/1796 (2.8%)	57
Pharyngitis bacterial	2/903 (0.2%)	2	4/899 (0.4%)	4	1/897 (0.1%)	1	5/1796 (0.3%)	5
Pharyngitis streptococcal	30/903 (3.3%)	34	25/899 (2.8%)	28	26/897 (2.9%)	31	51/1796 (2.8%)	59
Pharyngotonsillitis	2/903 (0.2%)	2	4/899 (0.4%)	4	1/897 (0.1%)	1	5/1796 (0.3%)	5
Pilonidal cyst	2/903 (0.2%)	3	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Pneumonia	3/903 (0.3%)	3	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Pneumonia bacterial	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pneumonia mycoplasmal	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Post procedural cellulitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Primary syphilis	6/903 (0.7%)	6	10/899 (1.1%)	10	5/897 (0.6%)	5	15/1796 (0.8%)	15
Proctitis bacterial	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Proctitis chlamydial	0/903 (0%)	0	1/899 (0.1%)	1	3/897 (0.3%)	3	4/1796 (0.2%)	4
Proctitis gonococcal	124/903 (13.7%)	152	121/899 (13.5%)	151	125/897 (13.9%)	146	246/1796 (13.7%)	297
Proctitis herpes	5/903 (0.6%)	5	4/899 (0.4%)	4	2/897 (0.2%)	3	6/1796 (0.3%)	7
Pulmonary tuberculosis	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Puncture site infection	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pustule	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pyelonephritis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Rash pustular	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Respiratory tract infection	3/903 (0.3%)	3	3/899 (0.3%)	3	5/897 (0.6%)	5	8/1796 (0.4%)	8
Respiratory tract infection viral	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Rhinitis	1/903 (0.1%)	1	0/899 (0%)	0	5/897 (0.6%)	5	5/1796 (0.3%)	5
Schistosomiasis cutaneous	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Scrotal abscess	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Secondary syphilis	4/903 (0.4%)	4	8/899 (0.9%)	8	7/897 (0.8%)	7	15/1796 (0.8%)	15
Sexually transmitted disease	2/903 (0.2%)	2	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Shigella infection	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Sinusitis	33/903 (3.7%)	37	31/899 (3.4%)	38	31/897 (3.5%)	36	62/1796 (3.5%)	74
Sinusitis bacterial	2/903 (0.2%)	2	3/899 (0.3%)	3	1/897 (0.1%)	2	4/1796 (0.2%)	5
Skin bacterial infection	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Skin candida	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Skin infection	3/903 (0.3%)	3	2/899 (0.2%)	3	4/897 (0.4%)	4	6/1796 (0.3%)	7
Soft tissue infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Staphylococcal infection	0/903 (0%)	0	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Staphylococcal skin infection	0/903 (0%)	0	0/899 (0%)	0	3/897 (0.3%)	3	3/1796 (0.2%)	3
Strongyloidiasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Subcutaneous abscess	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Syphilis	52/903 (5.8%)	55	74/899 (8.2%)	79	76/897 (8.5%)	78	150/1796 (8.4%)	157
Syphilis anal	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Syphilis genital	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tinea cruris	6/903 (0.7%)	6	3/899 (0.3%)	4	7/897 (0.8%)	7	10/1796 (0.6%)	11
Tinea faciei	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tinea infection	1/903 (0.1%)	1	4/899 (0.4%)	5	2/897 (0.2%)	2	6/1796 (0.3%)	7
Tinea pedis	2/903 (0.2%)	2	7/899 (0.8%)	7	4/897 (0.4%)	4	11/1796 (0.6%)	11
Tinea versicolour	4/903 (0.4%)	5	1/899 (0.1%)	1	4/897 (0.4%)	5	5/1796 (0.3%)	6
Tonsillitis	11/903 (1.2%)	12	15/899 (1.7%)	15	15/897 (1.7%)	17	30/1796 (1.7%)	32
Tonsillitis bacterial	1/903 (0.1%)	1	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Tonsillitis streptococcal	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Tooth abscess	3/903 (0.3%)	3	1/899 (0.1%)	1	10/897 (1.1%)	10	11/1796 (0.6%)	11
Tooth infection	11/903 (1.2%)	12	11/899 (1.2%)	11	7/897 (0.8%)	8	18/1796 (1%)	19
Tuberculous pleurisy	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Upper respiratory tract infection	185/903 (20.5%)	285	160/899 (17.8%)	248	182/897 (20.3%)	280	342/1796 (19%)	528
Upper respiratory tract infection bacterial	2/903 (0.2%)	2	4/899 (0.4%)	4	0/897 (0%)	0	4/1796 (0.2%)	4
Urethral discharge syndrome	3/903 (0.3%)	3	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Urethritis	13/903 (1.4%)	17	22/899 (2.4%)	25	30/897 (3.3%)	31	52/1796 (2.9%)	56
Urethritis chlamydial	13/903 (1.4%)	13	21/899 (2.3%)	21	10/897 (1.1%)	10	31/1796 (1.7%)	31
Urethritis gonococcal	13/903 (1.4%)	13	12/899 (1.3%)	13	9/897 (1%)	9	21/1796 (1.2%)	22
Urethritis mycoplasmal	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Urinary tract infection	11/903 (1.2%)	11	11/899 (1.2%)	11	10/897 (1.1%)	11	21/1796 (1.2%)	22
Urinary tract infection bacterial	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Vaginitis chlamydial	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Varicella	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Varicella zoster virus infection	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Viral infection	27/903 (3%)	35	38/899 (4.2%)	44	32/897 (3.6%)	36	70/1796 (3.9%)	80
Viral pharyngitis	8/903 (0.9%)	11	7/899 (0.8%)	9	3/897 (0.3%)	3	10/1796 (0.6%)	12
Viral rash	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Viral sinusitis	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Viral tonsillitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Viral upper respiratory tract infection	22/903 (2.4%)	26	34/899 (3.8%)	46	29/897 (3.2%)	35	63/1796 (3.5%)	81
Vulvovaginal candidiasis	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Vulvovaginitis gonococcal	0/903 (0%)	0	2/899 (0.2%)	4	0/897 (0%)	0	2/1796 (0.1%)	4
Wound infection	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Wound infection bacterial	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Injury, poisoning and procedural complications
Any Event in SOC	117/903 (13%)	160	138/899 (15.4%)	194	127/897 (14.2%)	172	265/1796 (14.8%)	366
Alcohol poisoning	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Animal bite	4/903 (0.4%)	4	8/899 (0.9%)	8	1/897 (0.1%)	1	9/1796 (0.5%)	9
Ankle fracture	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Arthropod bite	14/903 (1.6%)	15	4/899 (0.4%)	4	10/897 (1.1%)	10	14/1796 (0.8%)	14
Back injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Barotitis media	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Bite	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Bone contusion	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Breast injury	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Burn oral cavity	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Burns first degree	1/903 (0.1%)	1	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Burns second degree	4/903 (0.4%)	4	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Cartilage injury	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Chemical burn	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Chemical burns of eye	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Chest injury	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Clavicle fracture	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Concussion	3/903 (0.3%)	4	4/899 (0.4%)	4	4/897 (0.4%)	4	8/1796 (0.4%)	8
Contusion	13/903 (1.4%)	13	15/899 (1.7%)	17	11/897 (1.2%)	11	26/1796 (1.4%)	28
Corneal abrasion	2/903 (0.2%)	2	3/899 (0.3%)	4	0/897 (0%)	0	3/1796 (0.2%)	4
Ear injury	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Epicondylitis	2/903 (0.2%)	3	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Exposure to communicable disease	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eye contusion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eye injury	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Face injury	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Facial bones fracture	2/903 (0.2%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Foot fracture	1/903 (0.1%)	1	5/899 (0.6%)	6	6/897 (0.7%)	6	11/1796 (0.6%)	12
Genital contusion	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Gun shot wound	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Hand fracture	1/903 (0.1%)	1	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Head injury	4/903 (0.4%)	4	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Human bite	2/903 (0.2%)	2	2/899 (0.2%)	3	1/897 (0.1%)	1	3/1796 (0.2%)	4
Incisional hernia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Infusion related reaction	5/903 (0.6%)	5	2/899 (0.2%)	2	4/897 (0.4%)	4	6/1796 (0.3%)	6
Joint dislocation	1/903 (0.1%)	1	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Joint injury	2/903 (0.2%)	2	4/899 (0.4%)	4	2/897 (0.2%)	2	6/1796 (0.3%)	6
Ligament injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ligament rupture	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Ligament sprain	14/903 (1.6%)	16	18/899 (2%)	19	7/897 (0.8%)	7	25/1796 (1.4%)	26
Limb crushing injury	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Limb injury	3/903 (0.3%)	3	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Lip injury	0/903 (0%)	0	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Mallet finger	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Meniscus injury	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Multiple fractures	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Multiple injuries	2/903 (0.2%)	2	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Muscle rupture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Muscle strain	6/903 (0.7%)	6	18/899 (2%)	19	16/897 (1.8%)	16	34/1796 (1.9%)	35
Nail injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nasal injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Oral contusion	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Overdose	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Penis injury	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Perineal injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Periorbital haematoma	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Peripheral nerve injury	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Poisoning	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Post concussion syndrome	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Post lumbar puncture syndrome	0/903 (0%)	0	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Post procedural constipation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Post procedural contusion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Post procedural haematoma	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Procedural dizziness	3/903 (0.3%)	3	1/899 (0.1%)	1	1/897 (0.1%)	2	2/1796 (0.1%)	3
Procedural headache	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Procedural hypotension	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Procedural pain	5/903 (0.6%)	6	8/899 (0.9%)	9	18/897 (2%)	23	26/1796 (1.4%)	32
Rib fracture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Scratch	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Skin abrasion	9/903 (1%)	9	15/899 (1.7%)	17	4/897 (0.4%)	4	19/1796 (1.1%)	21
Skin laceration	11/903 (1.2%)	12	20/899 (2.2%)	22	10/897 (1.1%)	10	30/1796 (1.7%)	32
Skin scar contracture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Spinal column injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Spinal fracture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Splinter	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Sunburn	0/903 (0%)	0	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Tendon rupture	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Thermal burn	5/903 (0.6%)	6	4/899 (0.4%)	4	8/897 (0.9%)	8	12/1796 (0.7%)	12
Thoracic vertebral fracture	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tibia fracture	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Tooth fracture	5/903 (0.6%)	5	2/899 (0.2%)	2	6/897 (0.7%)	6	8/1796 (0.4%)	8
Tooth injury	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Traumatic haematoma	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Ulna fracture	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Upper limb fracture	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Urethral injury	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Venomous sting	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Wound	1/903 (0.1%)	1	2/899 (0.2%)	2	4/897 (0.4%)	4	6/1796 (0.3%)	6
Wound complication	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Wound secretion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Wrist fracture	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Investigations
Any Event in SOC	323/903 (35.8%)	659	331/899 (36.8%)	618	319/897 (35.6%)	575	650/1796 (36.2%)	1193
Alanine aminotransferase increased	193/903 (21.4%)	321	187/899 (20.8%)	282	172/897 (19.2%)	265	359/1796 (20%)	547
Amylase increased	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Aspartate aminotransferase increased	26/903 (2.9%)	37	21/899 (2.3%)	29	22/897 (2.5%)	28	43/1796 (2.4%)	57
Bilirubin conjugated increased	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Blood albumin decreased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Blood alkaline phosphatase increased	4/903 (0.4%)	4	2/899 (0.2%)	3	3/897 (0.3%)	4	5/1796 (0.3%)	7
Blood bicarbonate decreased	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Blood bilirubin increased	6/903 (0.7%)	8	7/899 (0.8%)	12	5/897 (0.6%)	5	12/1796 (0.7%)	17
Blood cholesterol increased	3/903 (0.3%)	5	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Blood creatine increased	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Blood creatine phosphokinase increased	2/903 (0.2%)	3	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Blood creatinine increased	106/903 (11.7%)	146	101/899 (11.2%)	141	117/897 (13%)	152	218/1796 (12.1%)	293
Blood glucose decreased	1/903 (0.1%)	1	2/899 (0.2%)	3	1/897 (0.1%)	1	3/1796 (0.2%)	4
Blood glucose increased	7/903 (0.8%)	13	11/899 (1.2%)	14	12/897 (1.3%)	16	23/1796 (1.3%)	30
Blood potassium decreased	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Blood potassium increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Blood pressure increased	32/903 (3.5%)	51	34/899 (3.8%)	48	28/897 (3.1%)	46	62/1796 (3.5%)	94
Blood testosterone decreased	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Blood triglycerides increased	3/903 (0.3%)	4	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Blood uric acid increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Blood urine present	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Body temperature increased	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Cardiac murmur	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Creatinine renal clearance decreased	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Creatinine renal clearance increased	1/903 (0.1%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Eosinophil count increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Glomerular filtration rate abnormal	1/903 (0.1%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Haemoglobin decreased	4/903 (0.4%)	4	8/899 (0.9%)	9	5/897 (0.6%)	6	13/1796 (0.7%)	15
Heart rate increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
International normalised ratio increased	2/903 (0.2%)	2	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Low density lipoprotein increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Lymph node palpable	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Lymphocyte count decreased	1/903 (0.1%)	1	4/899 (0.4%)	4	3/897 (0.3%)	3	7/1796 (0.4%)	7
Neutrophil count decreased	16/903 (1.8%)	21	27/899 (3%)	43	14/897 (1.6%)	22	41/1796 (2.3%)	65
Platelet count decreased	7/903 (0.8%)	11	8/899 (0.9%)	8	5/897 (0.6%)	6	13/1796 (0.7%)	14
Prostatic specific antigen increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Protein urine present	2/903 (0.2%)	2	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Prothrombin time prolonged	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Red blood cell schistocytes present	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Red blood cells urine	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Transaminases increased	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Urine analysis abnormal	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Vitamin D decreased	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
White blood cell count decreased	4/903 (0.4%)	4	5/899 (0.6%)	9	2/897 (0.2%)	4	7/1796 (0.4%)	13
Metabolism and nutrition disorders
Any Event in SOC	12/903 (1.3%)	12	20/899 (2.2%)	21	17/897 (1.9%)	21	37/1796 (2.1%)	42
Abnormal loss of weight	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	3	3/1796 (0.2%)	4
Dairy intolerance	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Decreased appetite	2/903 (0.2%)	2	6/899 (0.7%)	6	2/897 (0.2%)	2	8/1796 (0.4%)	8
Dehydration	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	2	2/1796 (0.1%)	3
Dyslipidaemia	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Glucose tolerance impaired	0/903 (0%)	0	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Gout	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Hypercholesterolaemia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hyperglycaemia	0/903 (0%)	0	1/899 (0.1%)	2	1/897 (0.1%)	1	2/1796 (0.1%)	3
Hyperlipidaemia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypoglycaemia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypokalaemia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Insulin resistance	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Iron deficiency	2/903 (0.2%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Type 2 diabetes mellitus	0/903 (0%)	0	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Vitamin D deficiency	4/903 (0.4%)	4	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Musculoskeletal and connective tissue disorders
Any Event in SOC	97/903 (10.7%)	130	121/899 (13.5%)	160	95/897 (10.6%)	143	216/1796 (12%)	303
Ankle impingement	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Arthralgia	24/903 (2.7%)	26	34/899 (3.8%)	36	30/897 (3.3%)	34	64/1796 (3.6%)	70
Back pain	33/903 (3.7%)	34	27/899 (3%)	30	31/897 (3.5%)	36	58/1796 (3.2%)	66
Bursitis	0/903 (0%)	0	3/899 (0.3%)	3	4/897 (0.4%)	5	7/1796 (0.4%)	8
Coccydynia	3/903 (0.3%)	3	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Costochondritis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Exostosis	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Flank pain	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Foot deformity	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Groin pain	1/903 (0.1%)	1	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Inguinal mass	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Intervertebral disc protrusion	3/903 (0.3%)	4	4/899 (0.4%)	4	0/897 (0%)	0	4/1796 (0.2%)	4
Joint effusion	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Joint hyperextension	0/903 (0%)	0	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Joint swelling	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Limb mass	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Medial tibial stress syndrome	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Muscle contracture	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Muscle discomfort	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Muscle spasms	4/903 (0.4%)	4	6/899 (0.7%)	6	2/897 (0.2%)	2	8/1796 (0.4%)	8
Muscle tightness	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Musculoskeletal chest pain	2/903 (0.2%)	2	5/899 (0.6%)	5	3/897 (0.3%)	3	8/1796 (0.4%)	8
Musculoskeletal discomfort	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Musculoskeletal pain	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Musculoskeletal stiffness	4/903 (0.4%)	4	2/899 (0.2%)	2	2/897 (0.2%)	3	4/1796 (0.2%)	5
Myalgia	13/903 (1.4%)	15	20/899 (2.2%)	24	11/897 (1.2%)	11	31/1796 (1.7%)	35
Neck pain	1/903 (0.1%)	1	9/899 (1%)	9	8/897 (0.9%)	8	17/1796 (0.9%)	17
Osteoarthritis	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Osteochondrosis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Osteopenia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Pain in extremity	15/903 (1.7%)	17	16/899 (1.8%)	17	21/897 (2.3%)	22	37/1796 (2.1%)	39
Pain in jaw	1/903 (0.1%)	2	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Periarthritis	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Plantar fasciitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Rotator cuff syndrome	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Spinal osteoarthritis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Temporomandibular joint syndrome	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Tendon disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tendonitis	6/903 (0.7%)	6	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Tenosynovitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tenosynovitis stenosans	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC	19/903 (2.1%)	20	18/899 (2%)	21	13/897 (1.4%)	14	31/1796 (1.7%)	35
Acrochordon	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anal neoplasm	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Anogenital warts	9/903 (1%)	10	7/899 (0.8%)	8	8/897 (0.9%)	8	15/1796 (0.8%)	16
Basal cell carcinoma	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Benign neoplasm of testis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dysplastic naevus	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Hypergammaglobulinaemia benign monoclonal	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Leiomyoma	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Lipoma	1/903 (0.1%)	1	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Melanocytic naevus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Neurofibroma	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Oral papilloma	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Papilloma	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Penile wart	2/903 (0.2%)	2	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Skin papilloma	2/903 (0.2%)	2	4/899 (0.4%)	4	1/897 (0.1%)	1	5/1796 (0.3%)	5
Nervous system disorders
Any Event in SOC	47/903 (5.2%)	56	65/899 (7.2%)	78	61/897 (6.8%)	76	126/1796 (7%)	154
Altered state of consciousness	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Bell's palsy	1/903 (0.1%)	1	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Carpal tunnel syndrome	1/903 (0.1%)	1	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Cervical radiculopathy	0/903 (0%)	0	1/899 (0.1%)	2	1/897 (0.1%)	2	2/1796 (0.1%)	4
Circadian rhythm sleep disorder	0/903 (0%)	0	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Cubital tunnel syndrome	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Disturbance in attention	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dizziness	6/903 (0.7%)	7	9/899 (1%)	9	5/897 (0.6%)	6	14/1796 (0.8%)	15
Headache	22/903 (2.4%)	22	23/899 (2.6%)	25	27/897 (3%)	33	50/1796 (2.8%)	58
Hypoaesthesia	2/903 (0.2%)	2	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Hypogeusia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Hypotonia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Loss of consciousness	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Meralgia paraesthetica	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Migraine	3/903 (0.3%)	3	6/899 (0.7%)	9	1/897 (0.1%)	1	7/1796 (0.4%)	10
Nerve compression	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Nerve degeneration	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Neuropathy peripheral	0/903 (0%)	0	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Paraesthesia	2/903 (0.2%)	2	2/899 (0.2%)	2	5/897 (0.6%)	6	7/1796 (0.4%)	8
Parosmia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Peroneal nerve palsy	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Polyneuropathy	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Presyncope	5/903 (0.6%)	5	11/899 (1.2%)	11	5/897 (0.6%)	5	16/1796 (0.9%)	16
Sciatica	3/903 (0.3%)	3	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Seizure	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Sensory loss	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Somnolence	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Subarachnoid haemorrhage	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Syncope	2/903 (0.2%)	3	1/899 (0.1%)	1	6/897 (0.7%)	6	7/1796 (0.4%)	7
Tension headache	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Product Issues
Any Event in SOC	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Device dislocation	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Psychiatric disorders
Any Event in SOC	56/903 (6.2%)	78	56/899 (6.2%)	73	58/897 (6.5%)	75	114/1796 (6.3%)	148
Abnormal dreams	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Adjustment disorder	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Adjustment disorder with depressed mood	1/903 (0.1%)	1	1/899 (0.1%)	1	3/897 (0.3%)	3	4/1796 (0.2%)	4
Affective disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Alcohol abuse	4/903 (0.4%)	5	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Alcohol use disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Anxiety	4/903 (0.4%)	4	16/899 (1.8%)	16	13/897 (1.4%)	13	29/1796 (1.6%)	29
Anxiety disorder	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Apathy	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Attention deficit hyperactivity disorder	2/903 (0.2%)	2	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Bipolar II disorder	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Bipolar disorder	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Borderline personality disorder	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Bruxism	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Confusional state	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Depressed mood	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Depression	15/903 (1.7%)	15	19/899 (2.1%)	20	19/897 (2.1%)	19	38/1796 (2.1%)	39
Disorientation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Drug abuse	3/903 (0.3%)	3	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Generalised anxiety disorder	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Grief reaction	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypomania	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Initial insomnia	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Insomnia	11/903 (1.2%)	11	5/899 (0.6%)	5	11/897 (1.2%)	12	16/1796 (0.9%)	17
Intentional self-injury	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Irritability	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Libido decreased	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Major depression	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Mental disorder	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Mood altered	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Nightmare	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Obsessive-compulsive disorder	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Panic attack	3/903 (0.3%)	5	4/899 (0.4%)	4	3/897 (0.3%)	3	7/1796 (0.4%)	7
Panic disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Persistent depressive disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Post-traumatic stress disorder	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Psychotic disorder	1/903 (0.1%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Seasonal affective disorder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Sleep disorder	1/903 (0.1%)	2	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Social anxiety disorder	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Stress	0/903 (0%)	0	4/899 (0.4%)	4	5/897 (0.6%)	5	9/1796 (0.5%)	9
Substance abuse	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Suicidal ideation	5/903 (0.6%)	5	5/899 (0.6%)	5	4/897 (0.4%)	4	9/1796 (0.5%)	9
Tic	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Renal and urinary disorders
Any Event in SOC	87/903 (9.6%)	106	86/899 (9.6%)	117	91/897 (10.1%)	109	177/1796 (9.9%)	226
Bladder discomfort	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Bladder pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Calculus bladder	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Costovertebral angle tenderness	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Cystitis haemorrhagic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dysuria	16/903 (1.8%)	16	18/899 (2%)	19	12/897 (1.3%)	13	30/1796 (1.7%)	32
Glomerulonephritis chronic	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Glycosuria	2/903 (0.2%)	2	5/899 (0.6%)	6	2/897 (0.2%)	2	7/1796 (0.4%)	8
Haematuria	29/903 (3.2%)	32	34/899 (3.8%)	43	28/897 (3.1%)	36	62/1796 (3.5%)	79
Micturition urgency	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nephrolithiasis	3/903 (0.3%)	3	6/899 (0.7%)	7	9/897 (1%)	9	15/1796 (0.8%)	16
Nephropathy toxic	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pollakiuria	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Proteinuria	29/903 (3.2%)	35	19/899 (2.1%)	23	28/897 (3.1%)	30	47/1796 (2.6%)	53
Renal colic	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Renal cyst	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Sterile pyuria	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ureterolithiasis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Urethral discharge	8/903 (0.9%)	9	8/899 (0.9%)	8	11/897 (1.2%)	12	19/1796 (1.1%)	20
Urethral haemorrhage	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Urethral pain	1/903 (0.1%)	1	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Urinary hesitation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Urinary incontinence	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Urinary retention	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Urine abnormality	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Reproductive system and breast disorders
Any Event in SOC	40/903 (4.4%)	45	31/899 (3.4%)	33	37/897 (4.1%)	42	68/1796 (3.8%)	75
Balanoposthitis	5/903 (0.6%)	5	5/899 (0.6%)	5	9/897 (1%)	9	14/1796 (0.8%)	14
Benign prostatic hyperplasia	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Dysmenorrhoea	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Epididymal cyst	1/903 (0.1%)	1	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Erectile dysfunction	3/903 (0.3%)	3	0/899 (0%)	0	3/897 (0.3%)	3	3/1796 (0.2%)	3
Galactorrhoea	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Genital cyst	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Genital discharge	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Genital erythema	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Genital macule	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Genital odour	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Genital paraesthesia	1/903 (0.1%)	1	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Genital rash	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Genital ulceration	3/903 (0.3%)	3	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Gynaecomastia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Haematospermia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Nipple inflammation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nipple pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pelvic discomfort	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pelvic pain	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Penile blister	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Penile discharge	9/903 (1%)	9	5/899 (0.6%)	6	7/897 (0.8%)	8	12/1796 (0.7%)	14
Penile erythema	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Penile pain	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Penile rash	0/903 (0%)	0	4/899 (0.4%)	4	0/897 (0%)	0	4/1796 (0.2%)	4
Penis disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Perineal rash	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Prostatitis	4/903 (0.4%)	4	3/899 (0.3%)	3	3/897 (0.3%)	3	6/1796 (0.3%)	6
Pruritus genital	2/903 (0.2%)	2	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Scrotal dermatitis	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Scrotal pain	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Scrotal swelling	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Testicular cyst	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Testicular mass	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Testicular pain	1/903 (0.1%)	2	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Testicular torsion	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Vaginal discharge	1/903 (0.1%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	76/903 (8.4%)	91	69/899 (7.7%)	87	80/897 (8.9%)	100	149/1796 (8.3%)	187
Allergic pharyngitis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Allergic sinusitis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Asthma	4/903 (0.4%)	5	2/899 (0.2%)	3	5/897 (0.6%)	6	7/1796 (0.4%)	9
Bronchial hyperreactivity	0/903 (0%)	0	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Bronchospasm	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Cough	5/903 (0.6%)	5	11/899 (1.2%)	11	15/897 (1.7%)	17	26/1796 (1.4%)	28
Dry throat	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Dysphonia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Dyspnoea	0/903 (0%)	0	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Epistaxis	3/903 (0.3%)	3	0/899 (0%)	0	1/897 (0.1%)	2	1/1796 (0.1%)	2
Haemoptysis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Hiccups	1/903 (0.1%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Nasal cavity mass	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Nasal congestion	5/903 (0.6%)	5	6/899 (0.7%)	6	7/897 (0.8%)	7	13/1796 (0.7%)	13
Nasal discomfort	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nasal septum deviation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Nasal turbinate hypertrophy	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Oropharyngeal blistering	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Oropharyngeal discolouration	0/903 (0%)	0	1/899 (0.1%)	2	0/897 (0%)	0	1/1796 (0.1%)	2
Oropharyngeal pain	25/903 (2.8%)	26	24/899 (2.7%)	28	29/897 (3.2%)	35	53/1796 (3%)	63
Paranasal sinus discomfort	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pharyngeal erythema	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Pharyngeal inflammation	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pleurisy	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Pleuritic pain	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Productive cough	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Pulmonary mass	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Respiratory symptom	6/903 (0.7%)	8	5/899 (0.6%)	5	2/897 (0.2%)	5	7/1796 (0.4%)	10
Respiratory tract congestion	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Rhinalgia	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Rhinitis allergic	4/903 (0.4%)	4	4/899 (0.4%)	5	5/897 (0.6%)	5	9/1796 (0.5%)	10
Rhinorrhoea	2/903 (0.2%)	2	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Sinus congestion	5/903 (0.6%)	5	3/899 (0.3%)	3	6/897 (0.7%)	6	9/1796 (0.5%)	9
Sinus disorder	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Sleep apnoea syndrome	4/903 (0.4%)	4	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Throat irritation	2/903 (0.2%)	2	3/899 (0.3%)	3	3/897 (0.3%)	4	6/1796 (0.3%)	7
Tonsillar cyst	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Tonsillar erythema	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Tonsillar hypertrophy	1/903 (0.1%)	1	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Tonsillar inflammation	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Upper respiratory tract congestion	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Upper-airway cough syndrome	3/903 (0.3%)	3	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Vocal cord inflammation	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Vocal cord thickening	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Wheezing	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Skin and subcutaneous tissue disorders
Any Event in SOC	100/903 (11.1%)	121	136/899 (15.1%)	165	118/897 (13.2%)	146	254/1796 (14.1%)	311
Acanthosis nigricans	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Acne	5/903 (0.6%)	5	10/899 (1.1%)	11	3/897 (0.3%)	3	13/1796 (0.7%)	14
Acne cystic	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Actinic keratosis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Acute cutaneous lupus erythematosus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Alopecia	4/903 (0.4%)	5	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Alopecia areata	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Androgenetic alopecia	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Angioedema	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Blister	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Dermal cyst	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Dermatitis	3/903 (0.3%)	3	4/899 (0.4%)	4	6/897 (0.7%)	6	10/1796 (0.6%)	10
Dermatitis allergic	0/903 (0%)	0	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Dermatitis contact	13/903 (1.4%)	14	20/899 (2.2%)	20	16/897 (1.8%)	17	36/1796 (2%)	37
Drug eruption	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Dry skin	1/903 (0.1%)	1	5/899 (0.6%)	5	3/897 (0.3%)	3	8/1796 (0.4%)	8
Ecchymosis	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Eczema	3/903 (0.3%)	3	3/899 (0.3%)	3	8/897 (0.9%)	8	11/1796 (0.6%)	11
Erythema	2/903 (0.2%)	2	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Exfoliative rash	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Guttate psoriasis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hand dermatitis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hyperkeratosis	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Ingrowing nail	1/903 (0.1%)	1	2/899 (0.2%)	2	1/897 (0.1%)	1	3/1796 (0.2%)	3
Ingrown hair	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Intertrigo	0/903 (0%)	0	3/899 (0.3%)	3	1/897 (0.1%)	1	4/1796 (0.2%)	4
Keloid scar	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Lichen planus	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Macule	2/903 (0.2%)	2	3/899 (0.3%)	3	0/897 (0%)	0	3/1796 (0.2%)	3
Milia	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Miliaria	1/903 (0.1%)	1	1/899 (0.1%)	1	3/897 (0.3%)	3	4/1796 (0.2%)	4
Night sweats	1/903 (0.1%)	1	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Onychoclasis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Pain of skin	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Papule	5/903 (0.6%)	5	8/899 (0.9%)	9	11/897 (1.2%)	14	19/1796 (1.1%)	23
Pemphigus	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Penile ulceration	0/903 (0%)	0	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Petechiae	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Photosensitivity reaction	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Pityriasis	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Pityriasis rosea	0/903 (0%)	0	3/899 (0.3%)	3	2/897 (0.2%)	2	5/1796 (0.3%)	5
Post inflammatory pigmentation change	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Prurigo	0/903 (0%)	0	0/899 (0%)	0	3/897 (0.3%)	3	3/1796 (0.2%)	3
Pruritus	8/903 (0.9%)	9	4/899 (0.4%)	4	5/897 (0.6%)	5	9/1796 (0.5%)	9
Psoriasis	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Rash	11/903 (1.2%)	11	21/899 (2.3%)	22	7/897 (0.8%)	7	28/1796 (1.6%)	29
Rash erythematous	4/903 (0.4%)	4	8/899 (0.9%)	8	2/897 (0.2%)	2	10/1796 (0.6%)	10
Rash follicular	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Rash macular	5/903 (0.6%)	5	2/899 (0.2%)	2	3/897 (0.3%)	3	5/1796 (0.3%)	5
Rash maculo-papular	4/903 (0.4%)	4	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Rash morbilliform	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Rash papular	4/903 (0.4%)	4	4/899 (0.4%)	6	5/897 (0.6%)	6	9/1796 (0.5%)	12
Rash pruritic	4/903 (0.4%)	5	4/899 (0.4%)	4	7/897 (0.8%)	7	11/1796 (0.6%)	11
Rash vesicular	0/903 (0%)	0	0/899 (0%)	0	2/897 (0.2%)	2	2/1796 (0.1%)	2
Rosacea	2/903 (0.2%)	2	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Scab	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Seborrhoeic dermatitis	2/903 (0.2%)	2	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Skin burning sensation	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Skin discolouration	0/903 (0%)	0	2/899 (0.2%)	2	0/897 (0%)	0	2/1796 (0.1%)	2
Skin exfoliation	1/903 (0.1%)	1	4/899 (0.4%)	4	0/897 (0%)	0	4/1796 (0.2%)	4
Skin fissures	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Skin hyperpigmentation	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Skin irritation	0/903 (0%)	0	2/899 (0.2%)	2	2/897 (0.2%)	2	4/1796 (0.2%)	4
Skin mass	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Skin plaque	1/903 (0.1%)	1	3/899 (0.3%)	4	0/897 (0%)	0	3/1796 (0.2%)	4
Skin reaction	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Skin ulcer	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Urticaria	12/903 (1.3%)	13	16/899 (1.8%)	16	22/897 (2.5%)	26	38/1796 (2.1%)	42
Urticaria chronic	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Social circumstances
Any Event in SOC	0/903 (0%)	0	1/899 (0.1%)	1	1/897 (0.1%)	1	2/1796 (0.1%)	2
Physical assault	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Victim of sexual abuse	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Vascular disorders
Any Event in SOC	16/903 (1.8%)	17	9/899 (1%)	9	8/897 (0.9%)	9	17/1796 (0.9%)	18
Flushing	2/903 (0.2%)	3	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Haematoma	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hot flush	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1
Hypertension	13/903 (1.4%)	13	6/899 (0.7%)	6	3/897 (0.3%)	3	9/1796 (0.5%)	9
Hypertensive crisis	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Hypotension	1/903 (0.1%)	1	0/899 (0%)	0	0/897 (0%)	0	0/1796 (0%)	0
Orthostatic hypotension	0/903 (0%)	0	1/899 (0.1%)	1	2/897 (0.2%)	2	3/1796 (0.2%)	3
Peripheral venous disease	0/903 (0%)	0	1/899 (0.1%)	1	0/897 (0%)	0	1/1796 (0.1%)	1
Phlebitis superficial	0/903 (0%)	0	0/899 (0%)	0	1/897 (0.1%)	1	1/1796 (0.1%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.