Trial Outcomes & Findings for A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines (NCT NCT00232180)
NCT ID: NCT00232180
Last Updated: 2020-12-22
Results Overview
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2743 participants
Primary outcome timeframe
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
Results posted on
2020-12-22
Participant Flow
A total of 1597 participants who completed the double-blind phase, 1246 entered into the open-label phase and 351 participants were ineligible to participate the open-label phase.
Participant milestones
| Measure |
Eplerenone: Double-blind Phase
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Open Label Phase
Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m\^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
|
|---|---|---|---|
|
Double-blind (DB) Phase
STARTED
|
1367
|
1376
|
0
|
|
Double-blind (DB) Phase
Treated
|
1364
|
1372
|
0
|
|
Double-blind (DB) Phase
COMPLETED
|
826
|
771
|
0
|
|
Double-blind (DB) Phase
NOT COMPLETED
|
541
|
605
|
0
|
|
Open Label Phase
STARTED
|
0
|
0
|
1246
|
|
Open Label Phase
Treated
|
0
|
0
|
1245
|
|
Open Label Phase
COMPLETED
|
0
|
0
|
1098
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
148
|
Reasons for withdrawal
| Measure |
Eplerenone: Double-blind Phase
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Open Label Phase
Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m\^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
|
|---|---|---|---|
|
Double-blind (DB) Phase
Death
|
186
|
222
|
0
|
|
Double-blind (DB) Phase
Lost to Follow-up
|
34
|
28
|
0
|
|
Double-blind (DB) Phase
Withdrawal by Subject
|
131
|
148
|
0
|
|
Double-blind (DB) Phase
Protocol Violation
|
28
|
21
|
0
|
|
Double-blind (DB) Phase
Adverse Event
|
83
|
100
|
0
|
|
Double-blind (DB) Phase
Other
|
70
|
75
|
0
|
|
Double-blind (DB) Phase
Randomized but not treated
|
3
|
4
|
0
|
|
Double-blind (DB) Phase
Laboratory abnormality
|
6
|
7
|
0
|
|
Open Label Phase
Death
|
0
|
0
|
48
|
|
Open Label Phase
Lost to Follow-up
|
0
|
0
|
5
|
|
Open Label Phase
Protocol Violation
|
0
|
0
|
3
|
|
Open Label Phase
Study terminated by sponsor
|
0
|
0
|
3
|
|
Open Label Phase
Withdrawal by Subject
|
0
|
0
|
37
|
|
Open Label Phase
Other
|
0
|
0
|
16
|
|
Open Label Phase
Adverse Event
|
0
|
0
|
25
|
|
Open Label Phase
Laboratory abnormality
|
0
|
0
|
10
|
|
Open Label Phase
Randomized but not treated
|
0
|
0
|
1
|
Baseline Characteristics
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Baseline characteristics by cohort
| Measure |
Eplerenone
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Total
n=2743 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than (<) 65 years
|
443 participants
n=5 Participants
|
441 participants
n=7 Participants
|
884 participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
594 participants
n=5 Participants
|
607 participants
n=7 Participants
|
1201 participants
n=5 Participants
|
|
Age, Customized
75 to 84 years
|
302 participants
n=5 Participants
|
299 participants
n=7 Participants
|
601 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 85 years
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
309 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
611 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1058 Participants
n=5 Participants
|
1074 Participants
n=7 Participants
|
2132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)Population: Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1364 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1373 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date
|
249 participants
|
356 participants
|
PRIMARY outcome
Timeframe: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)
|
288 participants
|
392 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
270 participants
|
376 participants
|
|
Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
311 participants
|
418 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Death due to any cause.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
171 participants
|
213 participants
|
|
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
205 participants
|
253 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
178 participants
|
215 participants
|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
147 participants
|
185 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
408 participants
|
491 participants
|
|
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
463 participants
|
552 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
164 participants
|
253 participants
|
|
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
186 participants
|
277 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
462 participants
|
569 participants
|
|
Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
530 participants
|
636 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
170 participants
|
262 participants
|
|
Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
194 participants
|
287 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation \[AF\], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
304 participants
|
399 participants
|
|
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
346 participants
|
439 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
45 participants
|
33 participants
|
|
Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
49 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
21 participants
|
26 participants
|
|
Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
24 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
61 participants
|
59 participants
|
|
Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
76 participants
|
78 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
33 participants
|
41 participants
|
|
Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
45 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
10 participants
|
10 participants
|
|
Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here "n" signifies participants evaluated at that time point.
First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (\>) 5.5 milliequivalents per liter (mEq/L).
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=1367 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1376 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)
Up to 50 months (cut-off) (n= 1364, 1373)
|
4 participants
|
3 participants
|
|
Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)
Up to 59.5 months (complete DB) (n= 1367, 1376)
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of atrial fibrillation at baseline and "n" signifies participants evaluated at that time point.
New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=956 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=940 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With New Onset Atrial Fibrillation or Flutter
Up to 50 months (cut-off) (n= 950, 937)
|
32 participants
|
52 participants
|
|
Number of Participants With New Onset Atrial Fibrillation or Flutter
Up to 59.5 months (complete DB) (n= 956, 940)
|
41 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)Population: FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of diabetes mellitus at baseline and "n" signifies participants evaluated at that time point.
The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.
Outcome measures
| Measure |
Eplerenone: Double-blind Phase
n=907 Participants
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=975 Participants
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
|---|---|---|
|
Number of Participants With New Onset Diabetes Mellitus (DM)
Up to 50 months (cut-off) (n= 904, 973)
|
34 participants
|
40 participants
|
|
Number of Participants With New Onset Diabetes Mellitus (DM)
Up to 59.5 months (complete DB) (n= 907, 975)
|
42 participants
|
47 participants
|
Adverse Events
Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)
Serious events: 509 serious events
Other events: 547 other events
Deaths: 0 deaths
Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)
Serious events: 614 serious events
Other events: 540 other events
Deaths: 0 deaths
Eplerenone: Double-blind Phase
Serious events: 586 serious events
Other events: 640 other events
Deaths: 0 deaths
Placebo: Double-blind Phase
Serious events: 686 serious events
Other events: 617 other events
Deaths: 0 deaths
Eplerenone: Open Label Phase
Serious events: 251 serious events
Other events: 329 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)
n=1360 participants at risk
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)
n=1369 participants at risk
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Double-blind Phase
n=1364 participants at risk
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1372 participants at risk
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Open Label Phase
n=1245 participants at risk
Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m\^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
|
|---|---|---|---|---|---|
|
Vascular disorders
Ischaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Microangiopathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Peripheral ischaemia
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Thrombophlebitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Vasculitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Venous thrombosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Shock
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Colposcopy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac arrest
|
0.96%
13/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.2%
17/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.74%
10/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.88%
12/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.66%
9/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.48%
6/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
11/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.81%
11/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.88%
11/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Angina pectoris
|
0.66%
9/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.95%
13/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.81%
11/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.3%
18/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.40%
5/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Angina unstable
|
1.8%
24/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.7%
23/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
27/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
30/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.72%
9/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Arrhythmia
|
0.66%
9/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
20/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
20/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
22/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
30/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
28/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.4%
33/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.56%
7/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrial flutter
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.40%
5/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Bradycardia
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Bundle branch block left
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac asthma
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac failure
|
13.8%
187/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
17.8%
243/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
16.0%
218/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
19.7%
270/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.5%
44/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.96%
13/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.4%
19/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.0%
14/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.3%
18/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.48%
6/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac perforation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Crepitations
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiogenic shock
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Conduction disorder
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Left ventricular failure
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
29/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
36/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.5%
34/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.48%
6/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Palpitations
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Pericardial effusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Sinus tachycardia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Tachycardia
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.74%
10/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.81%
11/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
17/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
27/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.4%
19/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.4%
33/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.64%
8/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Ear and labyrinth disorders
Haematotympanum
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Endocrine disorders
Goitre
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Endocrine disorders
Hyperthyroidism
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Endocrine disorders
Hypothyroidism
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Amaurosis fugax
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Cataract
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Diplopia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Phacolytic glaucoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Retinal detachment
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Anal fissure
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Ascites
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Duodenitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Melaena
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Proctitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Proctitis haemorrhagic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Vomiting
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Asthenia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Cardiac death
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Chest pain
|
1.5%
21/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
28/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.6%
22/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
31/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.56%
7/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Condition aggravated
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Death
|
1.9%
26/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.5%
34/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.9%
39/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.6%
50/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.96%
12/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device breakage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device dislocation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device lead damage
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device malfunction
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device occlusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device pacing issue
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Device stimulation issue
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Face oedema
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Fatigue
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
General physical health deterioration
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Hyperplasia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Impaired healing
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Implant site discharge
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Lipogranuloma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Malaise
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Mass
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Medical device complication
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Multi-organ failure
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Necrosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Oedema
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Oedema peripheral
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Pyrexia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Spinal pain
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Sudden cardiac death
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.80%
11/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.59%
8/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.87%
12/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Sudden death
|
0.74%
10/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.8%
24/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.7%
24/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.56%
7/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Abscess limb
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Bacteraemia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Breast abscess
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Bronchitis
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.88%
12/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.95%
13/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Bronchopneumonia
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Cellulitis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Cholecystitis infective
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Chronic sinusitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Cystitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Dengue fever
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Device related infection
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Gangrene
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Gastroenteritis
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Hepatobiliary infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Infected skin ulcer
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Influenza
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Intervertebral discitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Joint tuberculosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Kidney infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Localised infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Lung infection
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Meningitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Orchitis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Pneumonia
|
1.6%
22/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
32/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.4%
17/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Pyelonephritis
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Respiratory tract infection
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.87%
12/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Sepsis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Septic shock
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Urinary tract infection
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.59%
8/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Urosepsis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Viral infection
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Abscess
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Empyema
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Tuberculous laryngitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Infected sebaceous cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Fall
|
0.59%
8/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.66%
9/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.87%
12/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Dementia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Arteriogram
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Arteriogram coronary
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Arthroscopy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood creatinine increased
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood glucose abnormal
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood glucose increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood potassium increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood pressure increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Blood urea increased
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Carotid bruit
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
International normalised ratio increased
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Platelet count decreased
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Urine output decreased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Weight decreased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Investigations
Weight increased
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.59%
8/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Gout
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
16/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.4%
19/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Podagra
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm benign
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleura carcinoma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Ataxia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Balance disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Brain injury
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebral atrophy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebral haematoma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
15/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.4%
19/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
20/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.6%
22/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Coma
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Convulsion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Dizziness
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Dysarthria
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Epilepsy
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Headache
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Ischaemic stroke
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Polyneuropathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Syncope
|
1.8%
25/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
21/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.9%
26/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.6%
22/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.48%
6/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.66%
9/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.66%
9/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Tremor
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Anxiety
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Confusional state
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Depression
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Hallucination
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Pseudodementia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Restlessness
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Somatoform disorder cardiovascular
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Cardiac neurosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal failure
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.95%
13/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.2%
17/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal failure acute
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.66%
9/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal impairment
|
1.8%
25/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.3%
18/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
27/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
21/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.51%
7/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.59%
8/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Brain hypoxia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cheyne-Stokes respiration
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.58%
8/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.32%
4/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
14/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
28/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.2%
16/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
6/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.80%
11/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.51%
7/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.87%
12/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Bladder operation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiac pacemaker revision
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardiovascular event prophylaxis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cardioversion
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cervical conisation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Heart transplan
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.59%
8/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.88%
12/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.95%
13/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Lung neoplasm surgery
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Medical device implantation
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Mitral valve repair
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Prophylaxis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Renal transplant
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Thrombolysis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Vascular operation
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Aortic aneurysm
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.16%
2/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arterial insufficiency
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arteriosclerosis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Arteritis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Circulatory collapse
|
0.29%
4/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.29%
4/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Embolism
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Extremity necrosis
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Femoral artery occlusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Haematoma
|
0.15%
2/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypertension
|
0.37%
5/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.37%
5/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypertensive crisis
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.22%
3/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.36%
5/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypotension
|
0.22%
3/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.44%
6/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.73%
10/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.24%
3/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Iliac artery occlusion
|
0.07%
1/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.15%
2/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.08%
1/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.07%
1/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
Other adverse events
| Measure |
Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)
n=1360 participants at risk
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)
n=1369 participants at risk
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Double-blind Phase
n=1364 participants at risk
Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m\^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
|
Placebo: Double-blind Phase
n=1372 participants at risk
Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
|
Eplerenone: Open Label Phase
n=1245 participants at risk
Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m\^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
29/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
36/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.7%
37/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.1%
42/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.4%
42/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Cardiac disorders
Cardiac failure
|
5.1%
69/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
7.2%
99/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
6.2%
84/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
7.8%
107/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
29/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
27/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.95%
13/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
30/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
30/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.9%
40/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
35/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.4%
46/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
29/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.8%
38/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
30/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.8%
39/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Chest pain
|
2.4%
33/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
35/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.4%
33/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Fatigue
|
2.7%
37/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.4%
47/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.8%
38/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.9%
53/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.9%
36/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
General disorders
Oedema peripheral
|
3.2%
43/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
4.3%
59/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.8%
52/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
4.8%
66/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
32/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Bronchitis
|
3.5%
47/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.2%
44/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
4.0%
54/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.8%
52/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
45/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.0%
41/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.6%
49/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.5%
48/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
28/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
35/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
31/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
28/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.5%
34/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
25/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Gout
|
1.9%
26/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
31/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
30/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
36/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.2%
28/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.0%
95/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.1%
43/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
7.4%
101/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.5%
48/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.1%
38/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
14/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
27/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.0%
14/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
30/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
35/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
35/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.5%
43/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Nervous system disorders
Headache
|
2.1%
28/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.5%
34/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
32/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Renal and urinary disorders
Renal impairment
|
2.6%
35/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.5%
20/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.3%
45/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
27/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
50/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.0%
41/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
4.1%
56/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.4%
47/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
46/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.3%
45/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
4.0%
54/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.6%
49/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.1%
38/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
29/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.1%
15/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypertension
|
1.7%
23/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
36/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
28/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.7%
37/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Vascular disorders
Hypotension
|
3.2%
43/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
31/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
3.9%
53/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.4%
33/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.7%
33/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
28/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.9%
26/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.8%
24/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.3%
31/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.6%
32/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
29/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.0%
28/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.4%
30/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1360
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1369
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
2.1%
28/1364
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
1.9%
26/1372
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
0.00%
0/1245
The same event may appear as both an AE and a SAE. The numbers of subjects with each AE or SAE are summarized. If a subject had multiple episodes of the same AE or SAE during the study, only the most severe case of the AE or SAE for the subject are summarized.
|
Additional Information
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