Trial Outcomes & Findings for Japan Statin Treatment Against Recurrent Stroke (J-STARS) (NCT NCT00221104)
NCT ID: NCT00221104
Last Updated: 2018-01-25
Results Overview
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1578 participants
Primary outcome timeframe
up to 5 years
Results posted on
2018-01-25
Participant Flow
Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan
Participants were randomly assigned to the pravastatin group or the control with 1:1 allocation rate. The patient allocation was dynamically balanced with the stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence) between the two groups.
Participant milestones
| Measure |
Pravastatin Group
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Overall Study
STARTED
|
793
|
785
|
|
Overall Study
COMPLETED
|
710
|
709
|
|
Overall Study
NOT COMPLETED
|
83
|
76
|
Reasons for withdrawal
| Measure |
Pravastatin Group
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
42
|
29
|
|
Overall Study
Others
|
37
|
47
|
Baseline Characteristics
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Baseline characteristics by cohort
| Measure |
Pravastatin
n=793 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
Total
n=1578 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
335 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
664 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
458 Participants
n=5 Participants
|
456 Participants
n=7 Participants
|
914 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
545 Participants
n=5 Participants
|
542 Participants
n=7 Participants
|
1087 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
793 Participants
n=5 Participants
|
785 Participants
n=7 Participants
|
1578 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
793 participants
n=5 Participants
|
785 participants
n=7 Participants
|
1578 participants
n=5 Participants
|
|
Ischemic stroke subtype
Atherothrombotic infarction
|
195 participants
n=5 Participants
|
206 participants
n=7 Participants
|
401 participants
n=5 Participants
|
|
Ischemic stroke subtype
Lacunar infarction
|
502 participants
n=5 Participants
|
504 participants
n=7 Participants
|
1006 participants
n=5 Participants
|
|
Ischemic stroke subtype
Infarction of undetermined etiology
|
96 participants
n=5 Participants
|
75 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
High blood pressure
Yes
|
308 participants
n=5 Participants
|
309 participants
n=7 Participants
|
617 participants
n=5 Participants
|
|
High blood pressure
No
|
485 participants
n=5 Participants
|
476 participants
n=7 Participants
|
961 participants
n=5 Participants
|
|
Diabetes mellitus
Yes
|
185 participants
n=5 Participants
|
184 participants
n=7 Participants
|
369 participants
n=5 Participants
|
|
Diabetes mellitus
No
|
608 participants
n=5 Participants
|
601 participants
n=7 Participants
|
1209 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: intention to treat
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
Outcome measures
| Measure |
Pravastatin
n=793 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Incidence Rate of Stroke and TIA
|
2.56 events /100 person-years
Interval 2.04 to 3.08
|
2.65 events /100 person-years
Interval 2.12 to 3.18
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: intention to treat
Incidence rate of patients with atherothrombotic infarction
Outcome measures
| Measure |
Pravastatin
n=785 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=793 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Incidence Rate of Atherothrombotic Infarction
|
0.65 events /100 person-years
Interval 0.4 to 0.91
|
0.21 events /100 person-years
Interval 0.06 to 0.35
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: intention to treat
Incidence rate of patients with lacunar infarction
Outcome measures
| Measure |
Pravastatin
n=793 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Incidence Rate of Lacunar Infarction
|
1.26 events /100 person years
Interval 0.9 to 1.63
|
1.01 events /100 person years
Interval 0.69 to 1.33
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: intention to treat
Incidence rate of patients with cardioembolic infarction
Outcome measures
| Measure |
Pravastatin
n=793 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Incidence Rate of Cardioembolic Infarction
|
0.18 events /100 person-years
Interval 0.05 to 0.32
|
0.08 events /100 person-years
Interval 0.0 to 0.16
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: intention to treat
Incidence rate of patients with intracranial hemorrhage
Outcome measures
| Measure |
Pravastatin
n=793 Participants
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 Participants
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Incidence Rate of Intracranial Hemorrhage
|
0.29 events /100 person-years
Interval 0.12 to 0.46
|
0.31 events /100 person-years
Interval 0.14 to 0.49
|
Adverse Events
Pravastatin Group
Serious events: 188 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 164 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pravastatin Group
n=780 participants at risk
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
|
Control Group
n=785 participants at risk
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Angina pectoris
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Angina unstable
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.76%
6/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Arrhythmia
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Atrioventricular block second d
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Cardiac failure
|
0.77%
6/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.0%
8/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Myocardial infarction
|
0.64%
5/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.5%
12/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Cataract
|
1.2%
9/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.3%
10/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Cataract diabetic
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Eyelid oedema
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Glaucoma
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Anal polyp
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Colitis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Colonic polyp
|
1.2%
9/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.89%
7/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemo
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorr
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.64%
5/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrh
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Volvulus
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Gastrointestinal disorders
Vomiting
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Asthenia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Chest pain
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Death
|
5.5%
43/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
4.5%
35/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Hernia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Malaise
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Multi-organ failure
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Oedema
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Oedema peripheral
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Pyrexia
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Swelling
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Therapy responder
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
General disorders
Disuse syndrome
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Cholangitis
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Jaundice
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Appendicitis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Bronchitis
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Cellulitis
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Cystitis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Hepatitis B
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Herpes zoster
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Influenza
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pneumonia
|
1.8%
14/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.4%
11/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Sepsis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Encephalitis brain stem
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Enteritis infectious
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Pneumonia bacterial
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Biliary tract infection
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.77%
6/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
12/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.3%
10/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Injury
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Median nerve injury
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Investigations
Blood creatine phosphokinase in
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Investigations
Catheterisation cardiac
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate co
|
1.0%
8/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.9%
15/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.76%
6/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenu
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.89%
7/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.64%
5/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gingival cancer
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Autonomic nervous system imbala
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.64%
5/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.4%
11/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.1%
9/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Cerebral infarction
|
2.2%
17/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
2.4%
19/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Convulsion
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Dementia
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Dizziness
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Embolic stroke
|
0.90%
7/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Epilepsy
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Headache
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Syncope
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.90%
7/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
1.1%
9/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Reversible ischaemic neurologic
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Lacunar infarction
|
5.5%
43/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
5.0%
39/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Spinal cord infarction
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Parkinson's disease
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
1.0%
8/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
3.1%
24/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Psychiatric disorders
Completed suicide
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Psychiatric disorders
Depression
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Psychiatric disorders
Dissociative disorder
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Psychiatric disorders
Mental disorder
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Nephritis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Renal failure
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Reproductive system and breast disorders
Breast mass
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.25%
2/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary d
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.26%
2/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.51%
4/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Gastrostomy
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Hepatectomy
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Removal of foreign body
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Laminaplasty
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Surgical and medical procedures
Percutaneous coronary intervent
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Aortic aneurysm
|
0.51%
4/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Aortic dissection
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Hypertension
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Thrombophlebitis migrans
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Aortic rupture
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.00%
0/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Infarction
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Artery dissection
|
0.00%
0/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Arterial occlusive disease
|
0.13%
1/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.13%
1/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.38%
3/780 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
0.38%
3/785 • Mean length of follow-up was 4.89 years.
In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Director of Medical Statistics Division
Translational Research Informatics Center, Kobe, Hyogo
Phone: +81-78-303-9108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place