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Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Summary
EudraCT number	2020-003643-29
Trial protocol	GB FR DE ES BE
Global end of trial date	18 Jun 2023

Results information
Results version number	v1(current)
This version publication date	30 Jun 2024
First version publication date	30 Jun 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

VAC31518COV3009

ISRCTN number

US NCT number

NCT04614948

WHO universal trial number (UTN)

Sponsor organisation name

Janssen Vaccines & Prevention B.V.

Sponsor organisation address

Archimedesweg 4-6, Leiden, Netherlands, 2333

Public contact

Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

18 Jun 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

18 Jun 2023

Was the trial ended prematurely?

Main objective of the trial

The main objective of this trial was to demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seronegative adults.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Nov 2020

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 2981

Country: Number of subjects enrolled

Brazil: 500

Country: Number of subjects enrolled

Colombia: 2149

Country: Number of subjects enrolled

Germany: 100

Country: Number of subjects enrolled

Spain: 3132

Country: Number of subjects enrolled

France: 714

Country: Number of subjects enrolled

United Kingdom: 5905

Country: Number of subjects enrolled

Philippines: 1572

Country: Number of subjects enrolled

United States: 12579

Country: Number of subjects enrolled

South Africa: 2073

Worldwide total number of subjects

31705

EEA total number of subjects

6927

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

25993

From 65 to 84 years

5640

85 years and over

Subject disposition

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Recruitment details

Total of 31835 subjects were randomised, out of which 130 subjects were randomised but not vaccinated. Hence, 31705 subjects received vaccination in both double blind (DB) and open label (OL) phase. After completion of DB phases more subjects were enrolled therefore, the started count of DB+OL phase is exceeding the started count for DB phase.

Screening details

Due to change in the planned analysis, combined data of DB and OL phase was collected and analysed after completion of the DB phase. Results of safety endpoints were also collected and analysed for combined DB and OL phase. Hence, safety data is reported only in adverse event section and not repeated in the endpoint section.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Combined Double-blind and Open-label Phase: All Subjects

Arm description

Each subject was initially randomised to receive 1 dose of 0.5 millilitre (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5*10^10 viral particles (vp) vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, subjects could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all subjects were unblinded and entered OL phase, and those subjects that received placebo could receive a single dose of Ad26.COV2.S 5*10^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5*10^10 vp vaccine for those subjects that received a single dose of Ad26.COV2.S vaccine in the study.

Arm type

Experimental

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

Other name

Ad26COVS, JNJ-78436735, VAC31518

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57. Subjects who received a single dose of Ad26.COV2.S vaccine in the study (either in DB or OL phase) were offered a booster dose of Ad26.COV2.S 5*10^10 vp vaccine.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of Placebo matching to Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57.

Number of subjects in period 1	Combined Double-blind and Open-label Phase: All Subjects
Started	31705
Ad26.COV2.S Double Blind Phase	15708 ^[1]
Placebo Double Blind Phase	15592 ^[2]
Completed	21018
Not completed	10687
Adverse event, serious fatal	131
Physician decision	178
Consent withdrawn by subject	5922
Adverse event, non-fatal	14
Initiated prohibited medication	92
Technical problems	17
Protocol deviation	9
Rolled over into different clinical trial	48
Pregnancy	2
Unspecified	477
Lost to follow-up	3796
Sponsor decision	1

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Only reported subjects were planned in this milestone.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Only reported subjects were planned in this milestone.

Baseline characteristics

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Reporting group title

Combined Double-blind and Open-label Phase: All Subjects

Reporting group description

Reporting group values	Combined Double-blind and Open-label Phase: All Subjects	Total
Number of subjects	31705	31705
Title for AgeCategorical
Units: subjects
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	25993	25993
From 65 to 84 years	5640	5640
elderlyOver85	72	72
Missing	0	0
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	51.5 ( 14.46 )	-
Title for Gender
Units: subjects
Female	15032	15032
Male	16669	16669
Undifferentiated	4	4
Missing	0	0

End points

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Reporting group title

Combined Double-blind and Open-label Phase: All Subjects

Reporting group description

Subject analysis set title

Double Blind Phase: Ad26.COV2.S

Subject analysis set type

Full analysis

Subject analysis set description

Subjects received a single dose of 0.5 mL Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57.

Subject analysis set title

Double Blind Phase: Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Subjects received a single dose of placebo matching to Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57.

Primary: Double Blind Phase: Number of Subjects With Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 14 Days After the Second Vaccination ^[1]

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 RT-PCR or molecular test result from any respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom: respiratory rate(RR) greater than or equal to (>=)20 breaths/min; symptoms: shortness of breath or 2 signs/symptoms: heart rate (HR) >=90 beats/min and symptoms: cough. Severe/critical: 1 signs/symptoms: RR>=30breaths/min, HR>=125beats/min, oxygen saturation<=93%, respiratory failure, evidence of shock, significant acute renal, hepatic, neurologic dysfunction, admission to ICU, death per FDA guidance. PP set: subjects in FAS, received 2 doses of DB vaccine, PCR negative at 1st vaccination (vacc.), seronegative at 1st vacc. and at 14 days after 2nd vacc. and no protocol deviations to impact efficacy of vaccine before unblinding. Subjects with positive PCR test between Days 1 and 70 and who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Primary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analyzed for this endpoint.

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	14	52

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom: respiratory rate >= 20 breaths/minute (min) and symptoms such as shortness of breath or 2 signs/symptoms: heart rate >= 90 beats min and symptoms such as cough. Severe/critical: 1 of the following signs and symptoms: respiratory rate >=30 breaths/min, heart rate >=125 beats/min, oxygen saturation (SpO2) less than or equal to (<=) 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to Intensive Care Unit (ICU), death as per FDA guidance. Full analysis set (FAS): all randomised subjects with at least 1 documented study vaccine administration, regardless of protocol deviations and serostatus at enrollment.

End point type

Secondary

End point timeframe

From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	15708	15592
Units: Subjects	115	259

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom: RR >=20 breaths/min and symptoms: shortness of breath or 2 signs/symptoms as HR >=90 beats/min and symptoms: cough. Severe/critical: 1 signs and symptoms: RR >=30 breaths/min, HR >=125 beats/min, SpO2 <=93% respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to ICU, death as per FDA guidance. PP set: subjects in FAS who received 2 doses of DB vaccine, regardless of serostatus at time of 1st vacc. and at 14 days after 2nd vacc., were PCR negative at time of 1st vacc. and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Subjects with positive PCR test between Days 1 and 70 and who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6813	6370
Units: Subjects	14	53

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 1 Day After the First Day 1 Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 1 Day After the First Day 1 Vaccination

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom such as respiratory rate >=20 breaths/min and symptoms such as shortness of breath or 2 signs/symptoms such as heart rate >= 90 beats/min and symptoms such as cough. Severe/critical: 1 of the following signs and symptoms: respiratory rate >=30 breaths/min, heart rate >=125 beats/min, SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to ICU, death as per FDA guidance. Full analysis seronegative set included all randomised subjects with at least 1 documented study vaccine administration, regardless of protocol deviations and who were seronegative at baseline.

End point type

Secondary

End point timeframe

From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	13951	13871
Units: Subjects	112	256

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at least 14 Days After the First Day 1 Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at least 14 Days After the First Day 1 Vaccination

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom: RR >=20 breaths/min and symptoms: shortness of breath or 2 signs/symptoms: HR >= 90 beats/min and symptoms: cough. Severe/critical: 1 signs and symptoms: RR >=30 breaths/min, HR >=125 beats/min, SpO2 <=93% respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to ICU, death as per FDA guidance. Per-protocol first dose efficacy (PPFD) set: subjects in FAS who received at least 1st dose of vaccine in DB phase, PCR negative at 1st vacc., not seropositive at baseline and no major protocol deviations before unblinding to impact efficacy of vaccine. Subjects who had a positive PCR test between Days 1 and 14 and who discontinued prior to Day 15 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after first vaccination on Day 1 (Day 15) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	13316	13286
Units: Subjects	72	216

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination

End point description

Molecularly confirmed moderate to severe/critical COVID-19: SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (nasal swab/sputum/throat swab/saliva sample) or other sample. Moderate: 1 sign/symptom: RR >=20 breaths/min and symptoms: shortness of breath or 2 signs/symptoms: HR >= 90 beats/min and symptoms: cough. Severe/critical: 1 signs and symptoms: RR >=30 breaths/min, HR >=125 beats/min, SpO2 <=93% respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to ICU, death as per FDA guidance. PPFD set: subjects in FAS who received at least 1st dose of vaccine in DB phase and who were PCR negative at the time of 1st vacc, who were not seropositive at baseline and had no protocol deviations before unblinding to impact the efficacy of vaccine. Subjects who had a positive PCR test between Day 1 and Day 28 and who discontinued prior to Day 29 were excluded.

End point type

Secondary

End point timeframe

From at least 28 days after the first vaccination on Day 1 (Day 29) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	12632	12402
Units: Subjects	52	161

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of COVID-19 Requiring Medical Intervention With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of COVID-19 Requiring Medical Intervention With Onset at Least 14 Days After the Second Vaccination

End point description

Number of subjects with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO]), linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings and linked to any molecularly confirmed, COVID-19 with onset at least 14 days post second vaccination were reported. PP set: subjects in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	0	5

No statistical analyses for this end point

Secondary: Double Blind Phase: Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative RT-PCR in Subjects With Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After Second Vaccination

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End point title

Double Blind Phase: Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative RT-PCR in Subjects With Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After Second Vaccination

End point description

AUC of SARS-CoV-2 viral load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2. Due to change in the planned analysis, data was collected and analysed for subjects with molecularly confirmed symptomatic COVID-19 regardless of severity that is mild, moderate or severe and was not collected and analysed separately for moderate to severe cases. PP set: subjects in FAS who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Here, 'N' (number of subjects analysed) refers to the number of subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

From Day 71 up to end of the COVID-19 episode (up to 90 days)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	11	47
Units: Log10 copies*day per millilitre
arithmetic mean (standard error)	847.68 ( 242.375 )	1023.59 ( 156.298 )

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition With Onset at Least 14 Days After the Second Vaccination

End point description

Molecularly confirmed COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea. PP set: subjects in FAS who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	12	52

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Mild COVID-19 With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Mild COVID-19 With Onset at Least 14 Days After the Second Vaccination

End point description

Molecularly confirmed mild Covid-19: SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and any 1 signs and symptoms: fever (>=38 degree Celsius or >=100.4 degree Fahrenheit), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation/discharge, chills, new/changing olfactory/taste disorders, red/ bruised looking feet/toes, shaking chills or rigors. PP set: subjects in FAS who received 2 doses of DB vaccine, PCR negative at 1st vacc., seronegative at 1st vacc. and at 14 days after 2nd vacc. and no protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Days 1 and 70 and who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	0	1

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After the Second Vaccination

End point description

BOD was a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case. PP set: subjects in FAS (all randomised subjects with at least 1 documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment) who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	14	53

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Serologic Conversion Between Day 71 up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)

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End point title

Double Blind Phase: Number of Subjects With Serologic Conversion Between Day 71 up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)

End point description

Number of subjects with serologic conversion between Day 71 up to unblinding visit using an ELISA were reported. Due to change in planned analysis, data was collected and analysed between Day 71 up to unblinding visit instead of from baseline to unblinding visit. PP set: subjects in FAS (all randomised subjects with at least 1 documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment) who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From Day 71 up to unblinding visit (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	32	45

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) With Onset at Least 14 Days After the Second Vaccination

End point description

Number of subjects with asymptomatic infection detected by RT-PCR with onset at least 14 days after the second vaccination (Day 71) were reported. PP set: subjects in FAS (all randomised subjects with at least 1 documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment) who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	40	56

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) With Onset at Least 14 Days After the Second Vaccination

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End point title

Double Blind Phase: Number of Subjects With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) With Onset at Least 14 Days After the Second Vaccination

End point description

Number of subjects with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after the second vaccination (Day 71) were reported. PP set: subjects in FAS (all randomised subjects with at least 1 documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment) who received 2 doses of DB vaccine, PCR negative at 1st vaccination, seronegative at 1st vaccination and at 14 days after 2nd vaccination and no other protocol deviations to impact efficacy of vaccine before unblinding. Subjects who had a positive PCR test between Day 1 and Day 70 and subjects who discontinued prior to 14 days post-dose 2 were excluded.

End point type

Secondary

End point timeframe

From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	6024	5615
Units: Subjects	60	113

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Serious Adverse Events (SAEs)

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End point title

Double Blind Phase: Number of Subjects With Serious Adverse Events (SAEs)

End point description

An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. FAS post dose 1 population included FAS subjects excluding the subjects who received a COVID-19 vaccination outside of the study prior to first study vaccination.

End point type

Secondary

End point timeframe

From Day 1 up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	15705	15588
Units: Subjects	104	136

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Adverse Events of Special Interest (AESIs)

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End point title

Double Blind Phase: Number of Subjects With Adverse Events of Special Interest (AESIs)

End point description

Number of subjects with AESIs were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microlitre. FAS post dose 1 population included FAS subjects excluding the subjects who received a COVID-19 vaccination outside of the study prior to first study vaccination.

End point type

Secondary

End point timeframe

From Day 1 up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	15705	15588
Units: Subjects	2	1

No statistical analyses for this end point

Secondary: Double Blind: Number of Subjects With Medically-Attended Adverse Events (MAAEs)

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End point title

Double Blind: Number of Subjects With Medically-Attended Adverse Events (MAAEs)

End point description

An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. FAS post dose 1 population included FAS subjects excluding the subjects who received a COVID-19 vaccination outside of the study prior to first study vaccination.

End point type

Secondary

End point timeframe

From Day 1 up to 7.2 months

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	15705	15588
Units: Subjects	1033	1003

No statistical analyses for this end point

Secondary: Double Blind: Number of Subjects With MAAEs Leading to Study Discontinuation

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End point title

Double Blind: Number of Subjects With MAAEs Leading to Study Discontinuation

End point description

An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. FAS post dose 1 population included FAS subjects excluding the subjects who received a COVID-19 vaccination outside of the study prior to first study vaccination.

End point type

Secondary

End point timeframe

From Day 1 up to end of double blind phase (7.2 months)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	15705	15588
Units: Subjects	4	8

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination

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End point title

Double Blind Phase: Number of Subjects With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination

End point description

An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. Subjects who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post each vaccination (day of vaccination and the subsequent 7 days). Safety population was a subset of FAS for the analysis of solicited local adverse events. Here 'N' (number of subjects analysed) refers to the number of subjects evaluable for this endpoint and ‘n’ refers to all subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	3015	3052
Units: Subjects
Day 8 (n= 3015, 3052)	1676	653
Day 64 (n= 1559, 1425)	896	252

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Solicited Systemic AEs During 7 Days Following Each Vaccination

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End point title

Double Blind Phase: Number of Subjects With Solicited Systemic AEs During 7 Days Following Each Vaccination

End point description

Subjects who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Subjects recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Subjects also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia. Safety population: subset of FAS for the analysis of solicited systemic adverse events. N= number of subjects evaluable for this endpoint, n=all subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	3015	3052
Units: Subjects
Day 8 (n= 3015, 3052)	1764	1138
Day 64 (n= 1559, 1425)	821	442

No statistical analyses for this end point

Secondary: Double Blind Phase: Number of Subjects With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination

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End point title

Double Blind Phase: Number of Subjects With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination

End point description

An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. Unsolicited AEs were all AEs for which the subject is not specifically questioned in the subject diary. Safety population was a subset of FAS for the analysis of unsolicited adverse events. Here 'N' (number of subjects analysed) refers to the number of subjects evaluable for this endpoint and ‘n’ refers to all subjects evaluable at specified time points.

End point type

Secondary

End point timeframe

28 days after first vaccination on Day 1 (up to Day 29), 28 days after second vaccination on Day 57 (up to Day 85)

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	3015	3052
Units: Subjects
Day 29 (n= 3015, 3052)	454	332
Day 85 (n= 1559, 1425)	159	120

No statistical analyses for this end point

Secondary: Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA

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End point title

Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA

End point description

Binding antibodies to SARS-CoV-2 S protein as assessed by ELISA to measure humoral immune response was reported. The lower limit of quantification (LLOQ) was 50.3 ELISA units per millilitre (EU/mL). A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ). Per Protocol Immunogenicity (PPI) set: all randomised and vaccinated subjects (received both vaccines in DB phase, including those who were part of immunogenicity subset and for whom immunogenicity data were available, excluding subjects with major protocol deviations expected to impact immunogenicity outcomes. Here, N (number of subjects analysed) = subjects evaluated for this endpoint and 'n' = number of subjects evaluable at specified time points. 99999 signifies that geometric mean and 95% confidence interval could not be estimated as the analysed values were below the LLOQ (50.3 EU/mL).

End point type

Secondary

End point timeframe

At Baseline (Day 1), Days 29, 57 and 71

End point values	Double Blind Phase: Ad26.COV2.S	Double Blind Phase: Placebo
Number of subjects analysed	157	149
Units: ELISA Unit/millilitre (EU/mL)
geometric mean (confidence interval 95%)
Day 1 (n= 157, 149)	99999 (99999 to 99999)	99999 (99999 to 99999)
Day 29 (n= 140, 124)	367 (295 to 456)	99999 (99999 to 99999)
Day 57 (n= 150, 111)	518 (422 to 635)	99999 (99999 to 99999)
Day 71 (n= 78, 62)	2220 (1794 to 2748)	99999 (99999 to 99999)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-cause mortality/SAEs: DB phase: Day 1 till end of DB phase (up to 7.2 months), All subjects arm: Day 1 up to end of study (up to 2 years 6 months); Solicited AEs: 7 days after each DB vaccination (vacc.); Other AEs: Up to 28 days after each vacc.

Adverse event reporting additional description

Safety subset (FAS subset) used for solicited/unsolicited AEs. 9999=no subject at risk and affected for non-SAEs in 'All Subjects' arm. DB arms: AEs: coded with MedDRA v24.0. Deaths during DB phase included subjects discontinued study due to death at primary analysis, including subjects that died after unblinding, i.e. after end of DB phase.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Double Blind (DB) Phase: Ad26.COV2.S

Reporting group description

Subjects received a single dose of 0.5 mL Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57.

Reporting group title

Combined Double-blind and Open-label Phase: All Subjects

Reporting group description

Each subject was initially randomised to receive 1 dose of 0.5 millilitre (mL) Ad26.COV2.S 5*10^10 viral particles (vp) vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, subjects could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all subjects were unblinded and entered OL phase, and those subjects that received placebo could receive a single dose of Ad26.COV2.S 5*10^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5*10^10 vp vaccine for those subjects that received a single dose of Ad26.COV2.S vaccine in the study.

Reporting group title

Double Blind Phase: Placebo

Reporting group description

Subjects received a single dose of placebo matching to Ad26.COV2.S 5*10^10 vp vaccine intramuscularly on Day 1 and Day 57.

Serious adverse events	Double Blind (DB) Phase: Ad26.COV2.S	Combined Double-blind and Open-label Phase: All Subjects	Double Blind Phase: Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	104 / 15705 (0.66%)	1583 / 31705 (4.99%)	136 / 15588 (0.87%)
number of deaths (all causes)	6	131	13
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Adenocarcinoma Pancreas
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Leukaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Myeloid Leukaemia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign Neoplasm of Testis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Cancer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder Transitional Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Borderline Serous Tumour of Ovary
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer
subjects affected / exposed	0 / 15705 (0.00%)	22 / 31705 (0.07%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 23	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Metastatic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Recurrent
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Stage I
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Stage Ii
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adenocarcinoma of Colon
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adrenal Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Astrocytoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basal Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Cancer Stage Iv
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Gastrointestinal Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholesteatoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Lymphocytic Leukaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clear Cell Renal Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon Cancer
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Colorectal Cancer
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometrial Cancer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometrial Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fallopian Tube Cancer
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fibroma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Follicular Lymphoma Stage Iii
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Follicular Thyroid Cancer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchial Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Lung Neoplasm Malignant
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Lung Squamous Cell Carcinoma Stage Iii
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Cancer Metastatic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Lung Adenocarcinoma Stage 0
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Adenocarcinoma
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 1	0 / 0
Lipoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Invasive Lobular Breast Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Invasive Ductal Breast Carcinoma
subjects affected / exposed	1 / 15705 (0.01%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intraductal Proliferative Breast Lesion
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatocellular Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Carcinoma Cell Type Unspecified Stage Iv
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 3	0 / 0
Neuroendocrine Carcinoma of the Skin
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neoplasm Prostate
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neoplasm Progression
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Nasopharyngeal Cancer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic Renal Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic Malignant Melanoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Metastases to Spine
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to Central Nervous System
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to Bone
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Meningioma
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant Pleural Effusion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant Melanoma Stage I
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant Melanoma
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Hodgkin's Lymphoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Small Cell Lung Cancer Stage Iv
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Adenocarcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer Metastatic
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Prostate Cancer
subjects affected / exposed	2 / 15705 (0.01%)	29 / 31705 (0.09%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 33	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Plasma Cell Myeloma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pituitary Tumour Benign
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Phyllodes Tumour
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paget's Disease of Nipple
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian Cancer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteosarcoma
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Osteochondroma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Squamous Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Adenocarcinoma Stage Iii
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of Lung
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Squamous Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Meningioma Benign
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Cord Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small Cell Lung Cancer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Schwannoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of Pharynx
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Neoplasm
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal Adenocarcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic Adenoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer Stage I
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate Cancer Recurrent
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sarcoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Throat Cancer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transitional Cell Carcinoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour of Ampulla of Vater
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine Leiomyoma
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of Skin
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of the Hypopharynx
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of the Tongue
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous Cell Carcinoma of the Vulva
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Testis Cancer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Aortic Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Aortic Aneurysm Rupture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Aneurysm
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aneurysm Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aneurysm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Dilatation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Microscopic Polyangiitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intermittent Claudication
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iliac Artery Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypovolaemic Shock
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Hypotension
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive Urgency
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive Crisis
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Essential Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep Vein Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	9 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Circulatory Collapse
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Penetrating Aortic Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Arterial Occlusive Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Aneurysm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Occlusion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous Thrombosis Limb
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varicose Vein
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systolic Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Superficial Vein Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shock
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Venous Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Embolism
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral Artery Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ectopic Pregnancy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foetal Death
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gestational Diabetes
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gestational Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hellp Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Placenta Praevia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postpartum Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pre-Eclampsia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Premature Baby
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Premature Separation of Placenta
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abortion Spontaneous
subjects affected / exposed	0 / 15705 (0.00%)	9 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Malaise
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Accidental Death
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Capsular Contracture Associated with Implant
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest Discomfort
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest Pain
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	1 / 15705 (0.01%)	19 / 31705 (0.06%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 19	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 19	0 / 0
Death Neonatal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Gait Disturbance
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hernia Pain
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injection Site Swelling
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple Organ Dysfunction Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Non-Cardiac Chest Pain
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oedema Peripheral
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 15705 (0.01%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 2	1 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden Death
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 1
Vascular Stent Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vaccination Site Pain
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 15705 (0.01%)	0 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Unevaluable event
subjects affected / exposed	0 / 15705 (0.00%)	0 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Immune system disorders
Allergy to Vaccine
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaphylactic Reaction
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Food Allergy
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Social circumstances
Miscarriage of Partner
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Homicide
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
Bereavement
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Erectile Dysfunction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abnormal Uterine Bleeding
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adnexal Torsion
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign Prostatic Hyperplasia
subjects affected / exposed	1 / 15705 (0.01%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Discomfort
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Enlargement
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical Dysplasia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colpocele
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cystocele
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic Ovarian Cyst
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian Cyst
subjects affected / exposed	0 / 15705 (0.00%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian Hyperstimulation Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic Fluid Collection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectocele
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine Prolapse
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vaginal Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vaginal Prolapse
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulvar Dysplasia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heavy Menstrual Bleeding
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Atelectasis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Respiratory Failure
subjects affected / exposed	1 / 15705 (0.01%)	12 / 31705 (0.04%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 6	0 / 0
Asthma
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis Chronic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasal Septum Deviation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Obstructive Pulmonary Disease
subjects affected / exposed	1 / 15705 (0.01%)	10 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Chylothorax
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cough
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea Exertional
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypersensitivity Pneumonitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Interstitial Lung Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mediastinal Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neonatal Dyspnoea
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obstructive Sleep Apnoea Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory Distress
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	2 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1	1 / 1
Pulmonary Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Hypertension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Embolism
subjects affected / exposed	1 / 15705 (0.01%)	35 / 31705 (0.11%)	4 / 15588 (0.03%)
occurrences causally related to treatment / all	1 / 1	1 / 36	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Congestion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax Spontaneous
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumomediastinum
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural Effusion
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngeal Swelling
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngeal Haematoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Organising Pneumonia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory Failure
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Psychiatric disorders
Drug Abuse
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Affective Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol Withdrawal Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anxiety
subjects affected / exposed	1 / 15705 (0.01%)	4 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bipolar Disorder
subjects affected / exposed	2 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bipolar I Disorder
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Completed Suicide
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Confusional State
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Conversion Disorder
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 15705 (0.01%)	10 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Depression Suicidal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Psychosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gender Dysphoria
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nicotine Dependence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-Traumatic Stress Disorder
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric Decompensation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychotic Disorder
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Schizoaffective Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Schizoaffective Disorder Bipolar Type
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Substance-Induced Psychotic Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicidal Ideation
subjects affected / exposed	1 / 15705 (0.01%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicide Attempt
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intentional Self-Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Product issues
Device Failure
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device Dislocation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prosthetic Cardiac Valve Malfunction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Gallbladder Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cirrhosis Alcoholic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile Duct Stone
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary Cyst
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	2 / 15705 (0.01%)	10 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 10	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis Acute
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	3 / 15705 (0.02%)	19 / 31705 (0.06%)	3 / 15588 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 19	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gallbladder Polyp
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Cirrhosis
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Hepatic Cyst
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrocholecystis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Portal Vein Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gallbladder Rupture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Biopsy Liver
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Murmur
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrocardiogram St Segment Depression
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart Rate Irregular
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial Necrosis Marker Increased
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sleep Study
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Troponin Increased
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Acetabulum Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol Poisoning
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaesthetic Complication
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaphylactic Transfusion Reaction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Animal Bite
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ankle Fracture
subjects affected / exposed	1 / 15705 (0.01%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Avulsion Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone Graft Lysis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal Anastomotic Leak
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femur Fracture
subjects affected / exposed	1 / 15705 (0.01%)	7 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fractured Sacrum
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Forearm Fracture
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fibula Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Frostbite
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	1 / 15705 (0.01%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial Bones Fracture
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epicondylitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Craniocerebral Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clavicle Fracture
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Burns Third Degree
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain Contusion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus Fracture
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb Injury
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heat Exhaustion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Head Injury
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Hand Fracture
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gun Shot Wound
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ilium Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Intentional Overdose
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint Dislocation
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament Injury
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament Rupture
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament Sprain
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hip Fracture
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post Procedural Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post Procedural Complication
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Poisoning
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Overdose
subjects affected / exposed	1 / 15705 (0.01%)	4 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Patella Fracture
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic Fracture
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoradionecrosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neck Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle Rupture
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple Injuries
subjects affected / exposed	2 / 15705 (0.01%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Multiple Fractures
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscus Injury
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Vertebral Fracture
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower Limb Fracture
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lisfranc Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radius Fracture
subjects affected / exposed	0 / 15705 (0.00%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Synovial Rupture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural Pain
subjects affected / exposed	0 / 15705 (0.00%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural Complication
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-Traumatic Pain
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib Fracture
subjects affected / exposed	1 / 15705 (0.01%)	12 / 31705 (0.04%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Road Traffic Accident
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Seroma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skull Fractured Base
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Snake Bite
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Compression Fracture
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Fracture
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural Haematoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural Pneumothorax
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ulna Fracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper Limb Fracture
subjects affected / exposed	1 / 15705 (0.01%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Retention Postoperative
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wrist Fracture
subjects affected / exposed	1 / 15705 (0.01%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tendon Rupture
subjects affected / exposed	0 / 15705 (0.00%)	9 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tibia Fracture
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic Arthrosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic Intracranial Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital Tracheomalacia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertrophic Cardiomyopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngocele
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Phimosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brugada Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Angina Pectoris
subjects affected / exposed	2 / 15705 (0.01%)	14 / 31705 (0.04%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Coronary Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Myocardial Infarction
subjects affected / exposed	2 / 15705 (0.01%)	36 / 31705 (0.11%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 36	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 8	0 / 0
Angina Unstable
subjects affected / exposed	1 / 15705 (0.01%)	7 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Valve Incompetence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Valve Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Arrhythmia
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Arteriosclerosis Coronary Artery
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriospasm Coronary
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial Fibrillation
subjects affected / exposed	1 / 15705 (0.01%)	27 / 31705 (0.09%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 28	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Atrial Flutter
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial Tachycardia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block Complete
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block First Degree
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular Block Second Degree
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic Valve Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bundle Branch Block Left
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Arrest
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 4	0 / 1
Cardiac Disorder
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Failure
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cardiac Failure Acute
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac Failure Congestive
subjects affected / exposed	1 / 15705 (0.01%)	12 / 31705 (0.04%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Extrasystoles
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiovascular Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Congestive Cardiomyopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cor Pulmonale
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary Artery Disease
subjects affected / exposed	1 / 15705 (0.01%)	18 / 31705 (0.06%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 23	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Coronary Artery Occlusion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary Artery Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	11 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 13	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardio-Respiratory Arrest
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Heart Valve Incompetence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular Tachycardia
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Microvascular Coronary Artery Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral Valve Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral Valve Incompetence
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial Fibrosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial Infarction
subjects affected / exposed	1 / 15705 (0.01%)	24 / 31705 (0.08%)	4 / 15588 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 24	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 10	0 / 0
Myocardial Ischaemia
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
Palpitations
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pericardial Effusion
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus Bradycardia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus Node Dysfunction
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic Cardiomyopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular Tachycardia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular Fibrillation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tricuspid Valve Incompetence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular Arrhythmia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Aphasia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ataxia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bell's Palsy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain Injury
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Brain Oedema
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid Arteriosclerosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid Artery Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cerebellar Infarction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebellar Stroke
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral Amyloid Angiopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral Haemorrhage
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 2	0 / 0
Cerebral Infarction
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular Accident
subjects affected / exposed	3 / 15705 (0.02%)	12 / 31705 (0.04%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	1 / 3	0 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cervical Radiculopathy
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cognitive Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Ketoacidotic Hyperglycaemic Coma
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cauda Equina Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial Paresis
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic Stroke
subjects affected / exposed	2 / 15705 (0.01%)	12 / 31705 (0.04%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	2 / 12	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Haemorrhage Intracranial
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0
Haemorrhagic Stroke
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Hashimoto's Encephalopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	3 / 15705 (0.02%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic Encephalopathy
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglossal Nerve Paresis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Hypoxic-Ischaemic Encephalopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Intracranial Aneurysm
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Intracranial Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic Cerebral Infarction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Guillain-Barre Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lacunar Stroke
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peroneal Nerve Palsy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Radiculopathy
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Memory Impairment
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic Encephalopathy
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Migraine
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelitis Transverse
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuromyopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Normal Pressure Hydrocephalus
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nystagmus
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paresis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Partial Seizures
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Loss of Consciousness
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sunct Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subarachnoid Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tension Headache
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thalamic Infarction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient Global Amnesia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient Ischaemic Attack
subjects affected / exposed	1 / 15705 (0.01%)	14 / 31705 (0.04%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 14	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-Traumatic Epilepsy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Primary Headache Associated with Sexual Activity
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pseudostroke
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sciatica
subjects affected / exposed	1 / 15705 (0.01%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Claudication
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 15705 (0.00%)	11 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 15705 (0.00%)	10 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 11	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Anaemia Megaloblastic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile Neutropenia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune Thrombocytopenia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iron Deficiency Anaemia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelosuppression
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrogenic Anaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Splenic Vein Thrombosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 15705 (0.00%)	18 / 31705 (0.06%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	1 / 19	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia of Chronic Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness Neurosensory
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertigo
subjects affected / exposed	1 / 15705 (0.01%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Blindness Transient
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cataract
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diplopia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epiretinal Membrane
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal Detachment
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal Ischaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scleritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uveitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vitreous Detachment
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal Adhesions
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Abdominal Distension
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Hernia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Hernia Obstructive
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain
subjects affected / exposed	1 / 15705 (0.01%)	6 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain Lower
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Wall Haematoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal Fistula
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis Noninfective
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis Ischaemic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis Ulcerative
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Pain Upper
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Crohn's Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral Hernia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 15705 (0.01%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticular Perforation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal Ulcer Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal Ulcer Perforation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterocele
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterocutaneous Fistula
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epiploic Appendagitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erosive Oesophagitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diaphragmatic Hernia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhoidal Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhoids Thrombosed
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiatus Hernia
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal Hernia
subjects affected / exposed	2 / 15705 (0.01%)	16 / 31705 (0.05%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 19	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer Perforation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Gastrointestinal Ulcer Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal Reflux Disease
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Obstruction
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Prolapse
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Strangulation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intra-Abdominal Haematoma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large Intestinal Obstruction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large Intestine Polyp
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower Gastrointestinal Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Hernia
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mesenteric Panniculitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obstructive Defaecation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Obstruction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal Perforation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal Varices Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tongue Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Oral Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis Acute
subjects affected / exposed	0 / 15705 (0.00%)	7 / 31705 (0.02%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 7	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis Necrotising
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic Ulcer Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritoneal Hernia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngo-Oesophageal Diverticulum
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal Haemorrhage
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retroperitoneal Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Salivary Gland Mass
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small Intestinal Obstruction
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Umbilical Hernia
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varices Oesophageal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Volvulus of Small Bowel
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper Gastrointestinal Haemorrhage
subjects affected / exposed	1 / 15705 (0.01%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stevens-Johnson Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin Ulcer
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Foot
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alopecia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Calculus Urinary
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute Kidney Injury
subjects affected / exposed	0 / 15705 (0.00%)	10 / 31705 (0.03%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 10	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Calculus Bladder
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral Obstruction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral Haemorrhage
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Kidney Disease
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
End Stage Renal Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 15705 (0.01%)	15 / 31705 (0.05%)	3 / 15588 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 16	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Colic
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Cyst
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Failure
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Impairment
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal Mass
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stress Urinary Incontinence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urate Nephropathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	1 / 15705 (0.01%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Bladder Polyp
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Retention
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Obstruction
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Incontinence
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocrine disorders
Adrenal Insufficiency
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Autoimmune Thyroiditis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basedow's Disease
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Goitre
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Parathyroid Disorder
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid Cyst
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroiditis Acute
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infrapatellar Fat Pad Inflammation
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foot Deformity
subjects affected / exposed	0 / 15705 (0.00%)	9 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 11	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diastasis Recti Abdominis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chondropathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral Disc Protrusion
subjects affected / exposed	2 / 15705 (0.01%)	16 / 31705 (0.05%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 18	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back Pain
subjects affected / exposed	1 / 15705 (0.01%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chondrolysis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaw Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pain in Extremity
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	2 / 15705 (0.01%)	70 / 31705 (0.22%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 76	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neck Pain
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myalgia
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscular Weakness
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle Contracture
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscopathy
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar Spinal Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb Discomfort
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Knee Deformity
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertebral Lateral Recess Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tendon Disorder
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Synovitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Stenosis
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Pain
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal Osteoarthritis
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rotator Cuff Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	3 / 11	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendiceal Abscess
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal Wall Abscess
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess Jaw
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess Limb
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal Abscess
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	3 / 15705 (0.02%)	34 / 31705 (0.11%)	4 / 15588 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 35	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis Perforated
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arboviral Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis Bacterial
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aspergilloma
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacterial Sepsis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis Infective
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchopulmonary Aspergillosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Burn Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bursitis Infective
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Campylobacter Gastroenteritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Catheter Site Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	2 / 15705 (0.01%)	15 / 31705 (0.05%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 2	0 / 16	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bartholinitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic Hepatitis B
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium Difficile Colitis
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium Difficile Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colonic Abscess
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Complicated Appendicitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Covid-19
subjects affected / exposed	5 / 15705 (0.03%)	78 / 31705 (0.25%)	24 / 15588 (0.15%)
occurrences causally related to treatment / all	0 / 5	0 / 79	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 5	0 / 3
Diverticulitis
subjects affected / exposed	0 / 15705 (0.00%)	7 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cytomegalovirus Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dengue Fever
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device Related Infection
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Foot Infection
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disseminated Tuberculosis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
Covid-19 Pneumonia
subjects affected / exposed	3 / 15705 (0.02%)	45 / 31705 (0.14%)	13 / 15588 (0.08%)
occurrences causally related to treatment / all	0 / 3	0 / 46	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 9	0 / 3
Diverticulitis Intestinal Perforated
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected Bite
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia Pyelonephritis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia Urinary Tract Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye Infection Intraocular
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gangrene
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric Ulcer Helicobacter
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis Helminthic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis Escherichia Coli
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis Norovirus
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes Zoster
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiv Infection
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infective Exacerbation of Bronchiectasis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral Discitis
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Kidney Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Localised Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung Abscess
subjects affected / exposed	1 / 15705 (0.01%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphangitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningitis Viral
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningoencephalitis Herpetic
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Murine Typhus
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neurosyphilis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ophthalmic Herpes Zoster
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infectious Mononucleosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pseudomonas Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Plasmodium Falciparum Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumococcal Sepsis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	3 / 15705 (0.02%)	45 / 31705 (0.14%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 3	0 / 46	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 6	0 / 0
Pneumonia Aspiration
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Bacterial
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Pneumococcal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Pseudomonal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Staphylococcal
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Viral
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post Procedural Infection
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-Acute Covid-19 Syndrome
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic Inflammatory Disease
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shunt Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Septic Shock
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Sinusitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spontaneous Bacterial Peritonitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Streptococcal Bacteraemia
subjects affected / exposed	1 / 15705 (0.01%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Submandibular Abscess
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suspected Covid-19
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systemic Candida
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tubo-Ovarian Abscess
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary Tuberculosis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 15705 (0.01%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis Acute
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 15705 (0.01%)	22 / 31705 (0.07%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 29	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 5	0 / 0
Sialoadenitis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Infection
subjects affected / exposed	1 / 15705 (0.01%)	14 / 31705 (0.04%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 1	0 / 17	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary Tract Infection Bacterial
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 15705 (0.01%)	10 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Vestibular Neuronitis
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral Infection
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound Sepsis
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 15705 (0.01%)	0 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Adult Failure to Thrive
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	2 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 15705 (0.00%)	6 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypercholesterolaemia
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gout
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrolyte Imbalance
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic Ketoacidosis
subjects affected / exposed	0 / 15705 (0.00%)	4 / 31705 (0.01%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes Mellitus Inadequate Control
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	1 / 15588 (0.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes Mellitus
subjects affected / exposed	0 / 15705 (0.00%)	3 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Dehydration
subjects affected / exposed	1 / 15705 (0.01%)	8 / 31705 (0.03%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Decreased Appetite
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 2 Diabetes Mellitus
subjects affected / exposed	0 / 15705 (0.00%)	2 / 31705 (0.01%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 1 Diabetes Mellitus
subjects affected / exposed	0 / 15705 (0.00%)	1 / 31705 (0.00%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 15705 (0.00%)	5 / 31705 (0.02%)	0 / 15588 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Double Blind (DB) Phase: Ad26.COV2.S	Combined Double-blind and Open-label Phase: All Subjects	Double Blind Phase: Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	2234 / 15705 (14.22%)	9999 / 31705 (31.54%)	1531 / 15588 (9.82%)
Nervous system disorders
Headache
subjects affected / exposed ^[1]	138 / 3015 (4.58%)	9999 / 9999 (100.00%)	120 / 3052 (3.93%)
occurrences all number	156	9999	130
Headache(Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[2]	1432 / 3015 (47.50%)	9999 / 9999 (100.00%)	873 / 3052 (28.60%)
occurrences all number	2059	9999	1167
General disorders and administration site conditions
Fatigue
subjects affected / exposed ^[3]	128 / 3015 (4.25%)	9999 / 9999 (100.00%)	119 / 3052 (3.90%)
occurrences all number	146	9999	130
Vaccination site pain
subjects affected / exposed ^[4]	72 / 3015 (2.39%)	9999 / 9999 (100.00%)	23 / 3052 (0.75%)
occurrences all number	77	9999	23
Pyrexia(Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[5]	177 / 3015 (5.87%)	9999 / 9999 (100.00%)	18 / 3052 (0.59%)
occurrences all number	187	9999	18
Fatigue(Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[6]	1531 / 3015 (50.78%)	9999 / 9999 (100.00%)	897 / 3052 (29.39%)
occurrences all number	2212	9999	1189
Vaccination site erythema (Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[7]	311 / 3015 (10.32%)	9999 / 9999 (100.00%)	170 / 3052 (5.57%)
occurrences all number	399	9999	205
Vaccination site pain (Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[8]	1818 / 3015 (60.30%)	9999 / 9999 (100.00%)	664 / 3052 (21.76%)
occurrences all number	2680	9999	832
Vaccination site swelling (Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[9]	215 / 3015 (7.13%)	9999 / 9999 (100.00%)	65 / 3052 (2.13%)
occurrences all number	260	9999	74
Gastrointestinal disorders
Nausea(Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[10]	666 / 3015 (22.09%)	9999 / 9999 (100.00%)	387 / 3052 (12.68%)
occurrences all number	816	9999	457
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed ^[11]	99 / 3015 (3.28%)	9999 / 9999 (100.00%)	86 / 3052 (2.82%)
occurrences all number	119	9999	95
Myalgia(Solicited)
alternative assessment type: Systematic
subjects affected / exposed ^[12]	1346 / 3015 (44.64%)	9999 / 9999 (100.00%)	572 / 3052 (18.74%)
occurrences all number	1846	9999	718

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Only reported subjects were planned to be analysed for non-serious AEs in double blind arms. 9999 signifies that no subject at risk for non-serious AEs in 'All Subjects' arm.

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Were there any global substantial amendments to the protocol? Yes

25 Sep 2020

The overall reason for this amendment was to adjust the dose level of Ad26.COV2.S from 1*10^11 virus particle (vp) to 5*10^10 vp based on data from the first-in-human (FIH) study VAC31518COV1001.

27 Nov 2020

The overall reason for this amendment was to clarify that all subjects that had a reverse-transcriptase polymerase chain reaction (RT-PCR) positive finding for SARS-CoV-2 from any source, even if asymptomatic, were followed until there were two consecutive negative PCRs.

18 Dec 2020

The overall reason for this amendment was to outline the procedures to be followed in the event that an investigator receives a request to unblind study subjects who may become eligible to receive an authorised/licensed COVID-19 vaccine if/when these become available.

12 Mar 2021

The overall reason for this amendment was to outline the procedures to be followed after Ad26.COV2.S Emergency Use Authorization (EUA) in the United States (US) and approval of Protocol Amendment 4 by the local Health Authority and the Independent Ethics Committee/Institutional Review Board (IEC/IRB). A single dose of Ad26.COV2.S vaccine will be offered to enrolled subjects who initially received placebo, resulting in de facto unblinding of all subjects and investigators.

06 May 2021

The overall reason for this amendment was to include additional safety measures due to reports of adverse events following use of the Ad26.COV2.S vaccine under emergency use authorization in the US, suggesting an increased risk of thrombosis combined with thrombocytopenia.

15 Oct 2021

The overall reason for this amendment was to offer a 1-dose booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level to all ongoing subjects who received only a single vaccination with Ad26.COV2.S in the study.

27 Apr 2022

The overall reason for this amendment was vaccine Ad26.COV2.S had received EUA by the US Food and Drug Administration (FDA) and conditional marketing authorisation by the European Commission. Vaccine Ad26.COV2.S had also been authorized in several other countries/territories worldwide. The epidemic continued and new variants of concern emerged, and national recommendations introduced booster vaccinations.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Safety results for OL were included in the All Subjects arm and were not analysed separately. Hence, OL safety results are not repeated in endpoint section. FAS post dose-1 set was used to analyse safety in DB phase.

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Clinical trials

Clinical Trial Results: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Double Blind Phase: Number of Subjects With Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 14 Days After the Second Vaccination

Primary: Double Blind Phase: Number of Subjects With Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 1 Day After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Subjects With Onset at Least 1 Day After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at least 14 Days After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at least 14 Days After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of COVID-19 Requiring Medical Intervention With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of COVID-19 Requiring Medical Intervention With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative RT-PCR in Subjects With Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After Second Vaccination

Secondary: Double Blind Phase: Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative RT-PCR in Subjects With Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Mild COVID-19 With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of Molecularly Confirmed Mild COVID-19 With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With Serologic Conversion Between Day 71 up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Double Blind Phase: Number of Subjects With Serologic Conversion Between Day 71 up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)

Secondary: Double Blind Phase: Number of Subjects With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) With Onset at Least 14 Days After the Second Vaccination

Secondary: Double Blind Phase: Number of Subjects With Serious Adverse Events (SAEs)

Secondary: Double Blind Phase: Number of Subjects With Serious Adverse Events (SAEs)

Secondary: Double Blind Phase: Number of Subjects With Adverse Events of Special Interest (AESIs)

Secondary: Double Blind Phase: Number of Subjects With Adverse Events of Special Interest (AESIs)

Secondary: Double Blind: Number of Subjects With Medically-Attended Adverse Events (MAAEs)

Secondary: Double Blind: Number of Subjects With Medically-Attended Adverse Events (MAAEs)

Secondary: Double Blind: Number of Subjects With MAAEs Leading to Study Discontinuation

Secondary: Double Blind: Number of Subjects With MAAEs Leading to Study Discontinuation

Secondary: Double Blind Phase: Number of Subjects With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination

Secondary: Double Blind Phase: Number of Subjects With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination

Secondary: Double Blind Phase: Number of Subjects With Solicited Systemic AEs During 7 Days Following Each Vaccination

Secondary: Double Blind Phase: Number of Subjects With Solicited Systemic AEs During 7 Days Following Each Vaccination

Secondary: Double Blind Phase: Number of Subjects With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination

Secondary: Double Blind Phase: Number of Subjects With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination

Secondary: Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA

Secondary: Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older