Trial Outcomes & Findings for Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis (NCT NCT00544557)

Last Updated: 2015-05-12

Results Overview

Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.

Recruitment status

COMPLETED

Target enrollment

1715 participants

Primary outcome timeframe

Week 26

Results posted on

2015-05-12

Participant Flow

A total of 1715 participants were enrolled for documentation. Of these 1715 participants enrolled, only 1685 participants were included in analysis.

Participant milestones

Participant milestones
Measure	Etanercept Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Study STARTED	1685
Overall Study COMPLETED	1251
Overall Study NOT COMPLETED	434

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Study Adverse Event	140
Overall Study Lack of Efficacy	196
Overall Study Other	98

Baseline Characteristics

Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=1685 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Age, Continuous	43.9 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex/Gender, Customized Male	1067 participants n=5 Participants
Sex/Gender, Customized Female	615 participants n=5 Participants
Sex/Gender, Customized Missing	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Effectiveness population: all treated participants greater than or equal to (\>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Etanercept n=1305 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants Achieving Partial Remission at Week 26	19.0 percentage of participants Interval 16.9 to 21.2

PRIMARY outcome

Timeframe: Week 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' signifies participants who were evaluable for this outcome measure.

Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.

Outcome measures

Outcome measures
Measure	Etanercept n=1111 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants Achieving Partial Remission at Week 52	23.0 percentage of participants Interval 20.6 to 25.6

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety population included all treated participants with available post-baseline safety data.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.

Outcome measures

Outcome measures
Measure	Etanercept n=1685 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) SAEs	7.6 percentage of participants Interval 20.6 to 25.6
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) AEs	38.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety population included all treated participants with available post--baseline safety data.

Outcome measures

Outcome measures
Measure	Etanercept n=1685 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity SAEs	NA percentage of participants Interval 20.6 to 25.6 Data was not analyzed due to low number of participants.
Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity AEs	NA percentage of participants Data was not analyzed due to low number of participants.

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.

BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 Baseline (n=1635)	5.327 units on a scale Standard Deviation 2.029
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 Change at Week 52 (n=1128)	-2.199 units on a scale Standard Deviation 2.163

SECONDARY outcome

Timeframe: Baseline, Week 52

BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 Baseline (n=1626)	4.9 units on a scale Standard Deviation 2.4
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 Change at Week 52 (n=1129)	-1.7 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Week 52

Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Occiput-to-Wall Distance at Week 52 Baseline (n=1347)	6.7 centimeter (cm) Standard Deviation 7.8
Change From Baseline in Occiput-to-Wall Distance at Week 52 Change at Week 52 (n=788)	-0.7 centimeter (cm) Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline, Week 52

Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Lateral Lumbar Flexion at Week 52 Baseline (n=1123)	11.8 cm Standard Deviation 11.8
Change From Baseline in Lateral Lumbar Flexion at Week 52 Change at Week 52 (n=656)	1.0 cm Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline, Week 52

Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 Baseline (n=1630)	6.5 units on a scale Standard Deviation 2.2
Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 Change at Week 52 (n=1117)	-3.0 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 52

Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 Baseline (n=1602)	6.2 units on a scale Standard Deviation 2.3
Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 Change at Week 52 (n=1094)	-3.1 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 52

Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 Baseline (n=1655)	6.4 units on a scale Standard Deviation 1.6
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 Change at Week 52 (n=1171)	-4.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Week 52

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Duration of Morning Stiffness at Week 52 Baseline (n=1641)	58.6 minutes Standard Deviation 59.2
Change From Baseline in Duration of Morning Stiffness at Week 52 Change at Week 52 (n=1165)	-37.0 minutes Standard Deviation 54.0

SECONDARY outcome

Timeframe: Week 2, 6, 12, 26, 38, 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Significant Reduction of Morning Stiffness Week 2 (n=1405)	51.6 percentage of participants 59.2
Percentage of Participants With Significant Reduction of Morning Stiffness Week 6 (n=1452)	62.1 percentage of participants 31.4
Percentage of Participants With Significant Reduction of Morning Stiffness Week 12 (n=1480)	67.2 percentage of participants
Percentage of Participants With Significant Reduction of Morning Stiffness Week 26 (n=1395)	68.0 percentage of participants
Percentage of Participants With Significant Reduction of Morning Stiffness Week 38 (n=1235)	69.8 percentage of participants
Percentage of Participants With Significant Reduction of Morning Stiffness Week 52 (n=1186)	70.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 6, 12, 26, 38, 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.

Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Presence of Peripheral Arthritis Baseline (n=1663)	36.8 percentage of participants 59.2
Percentage of Participants With Presence of Peripheral Arthritis Week 2 (n=1405)	26.0 percentage of participants 31.4
Percentage of Participants With Presence of Peripheral Arthritis Week 6 (n=1452)	22.0 percentage of participants
Percentage of Participants With Presence of Peripheral Arthritis Week 12 (n=1480)	18.2 percentage of participants
Percentage of Participants With Presence of Peripheral Arthritis Week 26 (n=1395)	16.7 percentage of participants
Percentage of Participants With Presence of Peripheral Arthritis Week 38 (n=1235)	14.6 percentage of participants
Percentage of Participants With Presence of Peripheral Arthritis Week 52 (n=1186)	15.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 Baseline (n=1652)	2.2 joints Standard Deviation 5.5
Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 Change at Week 52 (n=1174)	-1.3 joints Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline, Week 2, 6, 12, 26, 38, 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.

Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Presence of Enthesitis Week 12 (n=1480)	9.5 percentage of participants
Percentage of Participants With Presence of Enthesitis Week 26 (n=1395)	8.5 percentage of participants
Percentage of Participants With Presence of Enthesitis Baseline (n=1663)	20.6 percentage of participants 59.2
Percentage of Participants With Presence of Enthesitis Week 2 (n=1405)	14.7 percentage of participants 31.4
Percentage of Participants With Presence of Enthesitis Week 6 (n=1452)	11.5 percentage of participants
Percentage of Participants With Presence of Enthesitis Week 38 (n=1235)	7.4 percentage of participants
Percentage of Participants With Presence of Enthesitis Week 52 (n=1186)	7.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 Baseline (n=1658)	0.6 body parts Standard Deviation 1.6
Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 Change at Week 52 (n=1174)	-0.4 body parts Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Week 52

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in C-Reactive Protein (CRP) at Week 52 Baseline (n=1497)	2.6 milligram per deciliter (mg/dL) Standard Deviation 4.7
Change From Baseline in C-Reactive Protein (CRP) at Week 52 Change at Week 52 (n=873)	-1.6 milligram per deciliter (mg/dL) Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline, Week 52

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 Baseline (n=1422)	26.9 mm/hr Standard Deviation 21.7
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 Change at Week 52 (n=812)	-14.2 mm/hr Standard Deviation 21.1

SECONDARY outcome

Timeframe: Week 12, 26, 38, 52

ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least \>= 20 percent improvement from baseline and an absolute change \>=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response Week 12 (n=1480)	60.6 percentage of participants Interval 58.0 to 63.3
Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response Week 26 (n=1395)	61.6 percentage of participants Interval 58.9 to 64.3
Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response Week 38 (n=1235)	63.1 percentage of participants Interval 60.3 to 66.0
Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response Week 52 (n=1186)	63.7 percentage of participants Interval 60.7 to 66.5

SECONDARY outcome

Timeframe: Week 12, 26, 38, 52

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (\>=) 40 percent improvement from baseline and an absolute change \>=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response Week 12 (n=1480)	44.1 percentage of participants Interval 41.4 to 46.8
Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response Week 26 (n=1395)	46.7 percentage of participants Interval 43.9 to 49.5
Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response Week 38 (n=1235)	48.6 percentage of participants Interval 45.6 to 51.5
Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response Week 52 (n=1186)	51.0 percentage of participants Interval 47.9 to 54.0

SECONDARY outcome

Timeframe: Baseline, Week 26, 52

EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) Baseline (n=1623)	0.58 units on a scale Standard Deviation 0.30 • Interval 41.4 to 46.8
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) Week 26 (n=1343)	0.80 units on a scale Standard Deviation 0.22 • Interval 43.9 to 49.5
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) Week 52 (n=1143)	0.82 units on a scale Standard Deviation 0.20 • Interval 47.9 to 54.0

SECONDARY outcome

Timeframe: Baseline, Week 26, 52

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) Baseline (n=1623)	54.3 units on a scale Standard Deviation 20.7 • Interval 41.4 to 46.8
Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) Week 26 (n=1343)	71.9 units on a scale Standard Deviation 19.2 • Interval 43.9 to 49.5
Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) Week 52 (n=1143)	74.2 units on a scale Standard Deviation 18.9 • Interval 47.9 to 54.0

SECONDARY outcome

Timeframe: Baseline, Week 26, 52

WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Baseline: Work Time Missed (n=776)	21.9 percentage of impairment Standard Deviation 36.3 • Interval 41.4 to 46.8
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Baseline: Impairment While Working (n=890)	48.3 percentage of impairment Standard Deviation 26.9 • Interval 43.9 to 49.5
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Baseline: Overall work impairment (n=716)	52.9 percentage of impairment Standard Deviation 29.8 • Interval 47.9 to 54.0
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Baseline: Activity impairment (n = 1624)	58.1 percentage of impairment Standard Deviation 24.6
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 26: Work Time Missed (n = 666)	6.6 percentage of impairment Standard Deviation 20.6
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 26: Impairment While Working (n = 799)	27.3 percentage of impairment Standard Deviation 23.1
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 26: Overall work impairment (n = 657)	29.8 percentage of impairment Standard Deviation 25.9
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 26: Activity impairment (n = 1331)	34.6 percentage of impairment Standard Deviation 24.6
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 52: Work Time Missed (n = 588)	6.3 percentage of impairment Standard Deviation 19.2
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 52: Impairment While Working (n = 706)	24.6 percentage of impairment Standard Deviation 21.9
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 52: Overall work impairment (n = 578)	26.3 percentage of impairment Standard Deviation 24.2
Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) Week 52: Activity impairment (n = 1137)	32.3 percentage of impairment Standard Deviation 24.9

SECONDARY outcome

Timeframe: Baseline, Week 26, 52

Population: Effectiveness population: all treated participants \>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.

Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Healthcare Resource Utilization Baseline: General Practitioner Visit (n=1654)	4.7 events Standard Deviation 8.3 • Interval 41.4 to 46.8
Healthcare Resource Utilization Baseline: Rheumatologist Visit (n=1657)	3.7 events Standard Deviation 3.3 • Interval 43.9 to 49.5
Healthcare Resource Utilization Baseline: Other Specialist Visit (n=1659)	1.6 events Standard Deviation 3.1 • Interval 47.9 to 54.0
Healthcare Resource Utilization Baseline: In-patient Hospitalization (n = 1658)	0.3 events Standard Deviation 0.9
Healthcare Resource Utilization Baseline: In-patient Rehabilitation (n = 1657)	0.2 events Standard Deviation 1.6
Healthcare Resource Utilization Baseline: Follow-up Treatment (n = 1662)	0.0 events Standard Deviation 0.1
Healthcare Resource Utilization Baseline: Out-patient Rehabilitation (n = 1661)	0.0 events Standard Deviation 0.8
Healthcare Resource Utilization Baseline: Physiotherapy (n = 1659)	9.1 events Standard Deviation 25.0
Healthcare Resource Utilization Baseline: Out-patient Hospitalization (n = 1663)	0.0 events Standard Deviation 0.1
Healthcare Resource Utilization Baseline: Ergotherapy (n = 1663)	0.0 events Standard Deviation 0.1
Healthcare Resource Utilization Baseline: Other Health Care Resources (n = 1662)	0.7 events Standard Deviation 7.4
Healthcare Resource Utilization Baseline: Sum Over All Care Resources (n = 1663)	20.3 events Standard Deviation 29.7
Healthcare Resource Utilization Week 26: General Practitioner Visit (n = 1389)	2.2 events Standard Deviation 3.1
Healthcare Resource Utilization Week 26: Rheumatologist Visit (n = 1392)	3.0 events Standard Deviation 2.6
Healthcare Resource Utilization Week 26: Other Specialist Visit (n = 1393)	0.6 events Standard Deviation 1.5
Healthcare Resource Utilization Week 26: In-patient Hospitalization (n = 1395)	0.1 events Standard Deviation 0.6
Healthcare Resource Utilization Week 26: In-patient Rehabilitation (n = 1392)	0.2 events Standard Deviation 1.9
Healthcare Resource Utilization Week 26: Follow-up Treatment (n = 1395)	0.0 events Standard Deviation 0.2
Healthcare Resource Utilization Week 26: Out-patient Rehabilitation (n = 1395)	0.0 events Standard Deviation 0.8
Healthcare Resource Utilization Week 26: Physiotherapy (n = 1395)	5.0 events Standard Deviation 14.1
Healthcare Resource Utilization Week 26: Out-patient Hospitalization (n = 1394)	0.0 events Standard Deviation 0.0
Healthcare Resource Utilization Week 26: Ergotherapy (n = 1395)	0.0 events Standard Deviation 0.5
Healthcare Resource Utilization Week 26: Other Health Care Resources (n = 1390)	0.5 events Standard Deviation 4.5
Healthcare Resource Utilization Week 26: Sum Over All Care Resources (n = 1395)	11.5 events Standard Deviation 16.9
Healthcare Resource Utilization Week 52: General Practitioner Visit (n = 1184)	1.8 events Standard Deviation 3.8
Healthcare Resource Utilization Week 52: Rheumatologist Visit (n = 1184)	2.0 events Standard Deviation 1.9
Healthcare Resource Utilization Week 52: Other Specialist Visit (n = 1183)	0.6 events Standard Deviation 2.6
Healthcare Resource Utilization Week 52: In-patient Hospitalization (n = 1186)	0.0 events Standard Deviation 0.2
Healthcare Resource Utilization Week 52: In-patient Rehabilitation (n = 1186)	0.1 events Standard Deviation 0.9
Healthcare Resource Utilization Week 52: Follow-up Treatment (n = 1186)	0.0 events Standard Deviation 0.0
Healthcare Resource Utilization Week 52: Out-patient Rehabilitation (n = 1186)	0.0 events Standard Deviation 0.7
Healthcare Resource Utilization Week 52: Physiotherapy (n = 1186)	4.3 events Standard Deviation 13.3
Healthcare Resource Utilization Week 52: Out-patient Hospitalization (n = 1186)	0.0 events Standard Deviation 0.0
Healthcare Resource Utilization Week 52: Ergotherapy (n = 1186)	0.0 events Standard Deviation 0.9
Healthcare Resource Utilization Week 52: Other Health Care Resources (n = 1185)	0.7 events Standard Deviation 5.1
Healthcare Resource Utilization Week 52: Sum Over All Care Resources (n = 1186)	9.6 events Standard Deviation 15.8

SECONDARY outcome

Timeframe: Baseline, Week 26, 52

Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.

Outcome measures

Outcome measures
Measure	Etanercept n=1663 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Duration of Healthcare Resources Utilization Week 52: Other Health Care Resources (n = 1162)	0.2 days Standard Deviation 2.5
Duration of Healthcare Resources Utilization Baseline: General Practitioner Visit (n=986)	3.7 days Standard Deviation 10.5 • Interval 41.4 to 46.8
Duration of Healthcare Resources Utilization Baseline: Rheumatologist Visit (n=928)	3.1 days Standard Deviation 5.7 • Interval 43.9 to 49.5
Duration of Healthcare Resources Utilization Baseline: Other Specialist Visit (n=1242)	0.9 days Standard Deviation 2.5 • Interval 47.9 to 54.0
Duration of Healthcare Resources Utilization Baseline: In-patient Hospitalization (n = 1633)	2.0 days Standard Deviation 5.7
Duration of Healthcare Resources Utilization Baseline: In-patient Rehabilitation (n = 1648)	1.5 days Standard Deviation 6.0
Duration of Healthcare Resources Utilization Baseline: Follow-up Treatment (n = 1661)	0.1 days Standard Deviation 1.8
Duration of Healthcare Resources Utilization Baseline: Out-patient Rehabilitation (n = 1654)	0.2 days Standard Deviation 3.6
Duration of Healthcare Resources Utilization Baseline: Physiotherapy (n = 1551)	6.2 days Standard Deviation 20.2
Duration of Healthcare Resources Utilization Baseline: Out-patient Hospitalization (n = 1661)	0.0 days Standard Deviation 0.0
Duration of Healthcare Resources Utilization Baseline: Ergotherapy (n = 1663)	0.0 days Standard Deviation 0.1
Duration of Healthcare Resources Utilization Baseline: Other Health Care Resources (n = 1641)	0.4 days Standard Deviation 6.0
Duration of Healthcare Resources Utilization Baseline: Sum Over All Care Resources (n = 1663)	14.5 days Standard Deviation 28.0
Duration of Healthcare Resources Utilization Week 26: General Practitioner Visit (n = 917)	1.2 days Standard Deviation 2.1
Duration of Healthcare Resources Utilization Week 26: Rheumatologist Visit (n = 834)	2.2 days Standard Deviation 2.7
Duration of Healthcare Resources Utilization Week 26: Other Specialist Visit (n = 1190)	0.4 days Standard Deviation 1.9
Duration of Healthcare Resources Utilization Week 26: In-patient Hospitalization (n = 1390)	0.3 days Standard Deviation 1.9
Duration of Healthcare Resources Utilization Week 26: In-patient Rehabilitation (n = 1391)	1.0 days Standard Deviation 5.1
Duration of Healthcare Resources Utilization Week 26: Follow-up Treatment (n = 1395)	0.0 days Standard Deviation 0.6
Duration of Healthcare Resources Utilization Week 26: Out-patient Rehabilitation (n = 1394)	0.1 days Standard Deviation 1.2
Duration of Healthcare Resources Utilization Week 26: Physiotherapy (n = 1350)	3.0 days Standard Deviation 9.9
Duration of Healthcare Resources Utilization Week 26: Out-patient Hospitalization (n = 1395)	0.0 days Standard Deviation 0.0
Duration of Healthcare Resources Utilization Week 26: Ergotherapy (n = 1393)	0.0 days Standard Deviation 0.4
Duration of Healthcare Resources Utilization Week 26: Other Health Care Resources (n = 1376)	0.3 days Standard Deviation 4.0
Duration of Healthcare Resources Utilization Week 26: Sum Over All Care Resources (n = 1395)	7.0 days Standard Deviation 14.5
Duration of Healthcare Resources Utilization Week 52: General Practitioner Visit (n = 762)	1.0 days Standard Deviation 1.7
Duration of Healthcare Resources Utilization Week 52: Rheumatologist Visit (n = 716)	1.5 days Standard Deviation 2.1
Duration of Healthcare Resources Utilization Week 52: Other Specialist Visit (n = 1009)	0.3 days Standard Deviation 2.3
Duration of Healthcare Resources Utilization Week 52: In-patient Hospitalization (n = 1177)	0.3 days Standard Deviation 2.0
Duration of Healthcare Resources Utilization Week 52: In-patient Rehabilitation (n = 1185)	0.4 days Standard Deviation 3.0
Duration of Healthcare Resources Utilization Week 52: Follow-up Treatment (n = 1186)	0.0 days Standard Deviation 0.0
Duration of Healthcare Resources Utilization Week 52: Out-patient Rehabilitation (n = 1186)	0.2 days Standard Deviation 3.7
Duration of Healthcare Resources Utilization Week 52: Physiotherapy (n = 1151)	2.6 days Standard Deviation 9.6
Duration of Healthcare Resources Utilization Week 52: Out-patient Hospitalization (n = 1186)	0.0 days Standard Deviation 0.0
Duration of Healthcare Resources Utilization Week 52: Ergotherapy (n = 1186)	0.0 days Standard Deviation 0.9
Duration of Healthcare Resources Utilization Week 52: Sum Over All Care Resources (n = 1186)	5.4 days Standard Deviation 13.9

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety population included all treated participants with available post-baseline safety data.

Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.

Outcome measures

Outcome measures
Measure	Etanercept n=1685 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis Concomitant Medication	38.4 percentage of participants Interval 58.0 to 63.3
Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis Prior Therapy	98.6 percentage of participants Interval 60.7 to 66.5

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety population included all treated participants with available post--baseline safety data.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Etanercept n=1685 Participants Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Percentage of Participants With Discontinuation of Treatment Due to Adverse Events	11.8 percentage of participants

Adverse Events

Etanercept

Serious events: 128 serious events

Other events: 588 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept n=1685 participants at risk Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Spondylitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Foot deformity	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint instability	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial haemangioma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal neoplasm benign	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Abdominal abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Anal abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Appendicitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Arthritis bacterial	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Campylobacter gastroenteritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Clostridium difficile colitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Erysipelas	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Meningitis aseptic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Meningitis viral	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pilonidal cyst	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pyelonephritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Staphylococcal infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Tonsillitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Tendon rupture	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Ankle fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fibula fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Injury	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Ligament rupture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Lymphatic duct rupture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Meniscus lesion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Seroma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Spinal fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Sports injury	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Tibia fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Crohn's disease	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Inguinal hernia	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Anal fistula	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Pancreatitis acute	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Pancreatitis chronic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Papilla of Vater stenosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Subileus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Umbilical hernia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Migraine with aura	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Aphasia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Carotid artery occlusion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Cerebrovascular accident	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Convulsion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Demyelination	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dysaesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dysgeusia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Hemianopia homonymous	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Leukoencephalopathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Monoplegia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Movement disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Paraesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Paraplegia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Thalamic infarction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Transient ischaemic attack	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders VIIth nerve paralysis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Coronary artery disease	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Myocardial infarction	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Angina pectoris	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Atrial fibrillation	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Acute myocardial infarction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiac failure	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Ischaemic cardiomyopathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Mitral valve incompetence	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Myocardial ischaemia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Pericardial effusion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Condition aggravated	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Drug ineffective	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Pain	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Impaired healing	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site hypersensitivity	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Hip surgery	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Implantable defibrillator insertion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Inguinal hernia repair	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Myringoplasty	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Removal of foreign body	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Spinal fusion surgery	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Tonsillectomy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Cholangitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Cholelithiasis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Bile duct stone	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Biliary colic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Cholecystitis acute	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Liver disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Psychogenic pain disorder	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Acute stress disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Depression	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Major depression	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Psychotic disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Sleep disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Calculus ureteric	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Nephrolithiasis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Renal colic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Urinary tract obstruction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Haematoma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Peripheral arterial occlusive disease	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Thrombosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Iritis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Cataract	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Diplopia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Maculopathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Endocrine disorders Goitre	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Arthroscopy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Transaminases increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Pregnancy, puerperium and perinatal conditions Premature baby	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Bone marrow disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Congenital, familial and genetic disorders Skull malformation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Immune system disorders Sarcoidosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Cervical polyp	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Other adverse events

Other adverse events
Measure	Etanercept n=1685 participants at risk Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Infections and infestations Nasopharyngitis	3.5% 59/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	1.9% 32/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	1.4% 24/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Infection	0.77% 13/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Sinusitis	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Oral herpes	0.47% 8/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Respiratory tract infection	0.47% 8/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pharyngitis	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Febrile infection	0.36% 6/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Cystitis	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Herpes simplex	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Herpes zoster	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchopneumonia	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Ear infection	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Furuncle	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Otitis media	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Rhinitis	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Tonsillitis	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Acute tonsillitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Laryngitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Erysipelas	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Folliculitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Fungal skin infection	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Gastroenteritis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Genital herpes	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Infection susceptibility increased	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Influenza	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Rash pustular	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Streptococcal infection	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Tracheobronchitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Acarodermatitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Cellulitis of male external genital organ	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Erythrasma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Gastroenteritis viral	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Gastrointestinal candidiasis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Gastrointestinal infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Genital candidiasis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Hepatitis B	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Hordeolum	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Injection site infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Oophoritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Otitis externa	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Paronychia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Perirectal abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Peritonsillar abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pilonidal cyst	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Pseudofolliculitis barbae	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Respiratory tract infection viral	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Soft tissue infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Subcutaneous abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Tinea pedis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Tooth abscess	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Vaginal candidiasis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Viral infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Viral tonsillitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Vulvovaginal mycotic infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Wound infection staphylococcal	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site erythema	4.1% 69/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site pruritus	1.2% 21/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site reaction	1.5% 25/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Condition aggravated	1.2% 20/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	0.83% 14/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site swelling	0.77% 13/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site irritation	0.59% 10/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Pyrexia	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site hypersensitivity	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Chest pain	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Local swelling	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Drug ineffective	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Drug intolerance	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders General physical health deterioration	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Impaired healing	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site pain	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site urticaria	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Pain	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site induration	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site macule	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site warmth	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Tenderness	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Application site erythema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Asthenia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Chest discomfort	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Feeling hot	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Granuloma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site dermatitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site discolouration	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site necrosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site oedema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site paraesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Injection site rash	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Local reaction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Localised oedema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Malaise	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Sensation of foreign body	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	1.1% 18/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Acne	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Alopecia	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Blister	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dry skin	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Eczema	0.47% 8/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Erythema	1.0% 17/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Erythema nodosum	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Exfoliative rash	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Generalised erythema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Nail psoriasis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Night sweats	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Periorbital oedema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pruritus generalised	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Psoriasis	0.59% 10/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash	0.59% 10/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash pruritic	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin reaction	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Urticaria	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Petechiae	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash macular	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash papular	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash vesicular	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin burning sensation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin induration	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin irritation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin nodule	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.95% 16/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.36% 6/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Enthesopathy	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Myosclerosis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Joint effusion	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle tightness	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Chondropathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Dactylitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Gouty tophus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Groin pain	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Periarthritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	1.1% 19/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	1.1% 19/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Crohn's disease	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Colitis ulcerative	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Haemorrhoids	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Periodontitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Colitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival pain	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal tenderness	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Anal fissure	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Anal fistula	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Aphthous stomatitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Breath odour	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Chapped lips	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Constipation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Dry mouth	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Enteritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Epiploic appendagitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Frequent bowel movements	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastric ulcer	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastritis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival bleeding	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Glossodynia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Haematochezia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Lip dry	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Mouth ulceration	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Pancreatitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Proctalgia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Radicular cyst	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Rectal haemorrhage	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Stomach discomfort	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Stomatitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Umbilical hernia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	1.1% 18/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	0.65% 11/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Paraesthesia	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Carpal tunnel syndrome	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Sciatica	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Syncope	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Hypoaesthesia	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Cervical root pain	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Cervicobrachial syndrome	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Movement disorder	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Sensory disturbance	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Amnesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Areflexia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Autonomic nervous system imbalance	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dysaesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dysgeusia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Hyperaesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Intercostal neuralgia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Meralgia paraesthetica	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Restless legs syndrome	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Somnolence	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Syncope vasovagal	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Alanine aminotransferase increased	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Gamma-glutamyltransferase increased	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Liver function test abnormal	0.36% 6/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Hepatic enzyme increased	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Blood alkaline phosphatase increased	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Haemoglobin decreased	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Transaminases increased	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Weight increased	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Arthroscopy	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Aspartate aminotransferase increased	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Blood creatinine increased	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Investigation	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Antinuclear antibody positive	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Bacterial test positive	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Biopsy prostate	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Blood pressure increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Blood urine present	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations C-reactive protein increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations DNA antibody positive	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Diagnostic procedure	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations ECG signs of myocardial ischaemia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Heart rate increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Laboratory test abnormal	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Lipase increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Lymphocyte count decreased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Red blood cell sedimentation rate increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Weight decreased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations White blood cell count decreased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Investigations Blood pressure diastolic increased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Emphysema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Iritis	0.53% 9/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Visual disturbance	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Conjunctivitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Ocular hyperaemia	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Uveitis	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Abnormal sensation in eye	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Cataract	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Dry eye	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Iridocyclitis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Diplopia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Eye swelling	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Eye disorders Eyelid oedema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Hospitalisation	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Carpal tunnel decompression	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Synoviorthesis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Abortion induced	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Angioplasty	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Ankle operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Arterial stent insertion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Baker's cyst excision	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Cataract operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Catheterisation cardiac	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Dental operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Dental treatment	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Hip arthroplasty	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Infiltration anaesthesia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Knee arthroplasty	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Ligament operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Neurolysis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Osteotomy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Skin operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Spinal deformity correction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Surgery	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Tendon operation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Tendon sheath incision	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Tonsillectomy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Tooth extraction	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.42% 7/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Drug exposure during pregnancy	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Meniscus lesion	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Accident	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Arthropod bite	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Concussion	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Excoriation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Foot fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Joint sprain	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Overdose	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Pelvic fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Skeletal injury	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Skin injury	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Tendon rupture	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	0.47% 8/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Cardiovascular insufficiency	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Thrombosis	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Haematoma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Hot flush	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertensive crisis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypotension	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Orthostatic hypotension	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Peripheral arterial occlusive disease	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Thrombophlebitis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Vascular disorders Varicose vein	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Depression	0.30% 5/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Depressed mood	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Insomnia	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Agitation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Alcohol abuse	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Libido decreased	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Mood swings	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Panic attack	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Somatoform disorder	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Tobacco abuse	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Angina pectoris	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiovascular disorder	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Coronary artery disease	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Mitral valve incompetence	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Palpitations	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Bradycardia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiac discomfort	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiac failure	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Cardiac disorders Mitral valve prolapse	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.36% 6/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Pregnancy, puerperium and perinatal conditions Delivery	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Pregnancy, puerperium and perinatal conditions First trimester pregnancy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Immune system disorders Hypersensitivity	0.24% 4/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Immune system disorders Sarcoidosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Immune system disorders Seasonal allergy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Gout	0.12% 2/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Anorexia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Cow's milk intolerance	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Obesity	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Anaemia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Anaemia macrocytic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Lymphadenopathy	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Ear pruritus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Inner ear inflammation	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Sudden hearing loss	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Ear and labyrinth disorders Tinnitus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Calculus urinary	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Dysuria	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Pollakiuria	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Renal colic	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Erectile dysfunction	0.18% 3/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Genital erythema	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Reproductive system and breast disorders Menstruation irregular	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Endocrine disorders Androgen deficiency	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Endocrine disorders Cushing's syndrome	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hepatic steatosis	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Campylobacter infection	0.06% 1/1685 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1--800--718--1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER