Trial Outcomes & Findings for Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study). (NCT NCT00986154)
NCT ID: NCT00986154
Last Updated: 2019-03-05
Results Overview
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8292 participants
Primary outcome timeframe
12 months from time of randomization
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Heparin/Edoxaban Tosylate
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Overall Study
STARTED
|
4143
|
4149
|
|
Overall Study
Safety Analysis Set (Received Drug)
|
4118
|
4122
|
|
Overall Study
COMPLETED
|
3937
|
3955
|
|
Overall Study
NOT COMPLETED
|
206
|
194
|
Reasons for withdrawal
| Measure |
Heparin/Edoxaban Tosylate
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Overall Study
Death
|
136
|
127
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
32
|
33
|
|
Overall Study
investigator/subject decide not continue
|
6
|
3
|
|
Overall Study
never received study drug
|
25
|
27
|
Baseline Characteristics
Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
Baseline characteristics by cohort
| Measure |
Heparin/Edoxaban Tosylate
n=4118 Participants
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 Participants
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
Total
n=8240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1758 Participants
n=5 Participants
|
1766 Participants
n=7 Participants
|
3524 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2360 Participants
n=5 Participants
|
2356 Participants
n=7 Participants
|
4716 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
|
866 Participants
n=5 Participants
|
861 Participants
n=7 Participants
|
1727 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
156 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2867 Participants
n=5 Participants
|
2895 Participants
n=7 Participants
|
5762 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
|
229 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
447 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
40 participants
n=5 Participants
|
44 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
307 participants
n=5 Participants
|
311 participants
n=7 Participants
|
618 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
74 participants
n=5 Participants
|
64 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
40 participants
n=5 Participants
|
36 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
18 participants
n=5 Participants
|
24 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
8 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
143 participants
n=5 Participants
|
148 participants
n=7 Participants
|
291 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
260 participants
n=5 Participants
|
257 participants
n=7 Participants
|
517 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
106 participants
n=5 Participants
|
125 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
27 participants
n=5 Participants
|
20 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
70 participants
n=5 Participants
|
83 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Region of Enrollment
India
|
245 participants
n=5 Participants
|
266 participants
n=7 Participants
|
511 participants
n=5 Participants
|
|
Region of Enrollment
France
|
364 participants
n=5 Participants
|
350 participants
n=7 Participants
|
714 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
123 participants
n=5 Participants
|
143 participants
n=7 Participants
|
266 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
90 participants
n=5 Participants
|
89 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
185 participants
n=5 Participants
|
180 participants
n=7 Participants
|
365 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
188 participants
n=5 Participants
|
197 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
Region of Enrollment
China
|
243 participants
n=5 Participants
|
241 participants
n=7 Participants
|
484 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
140 participants
n=5 Participants
|
130 participants
n=7 Participants
|
270 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
80 participants
n=5 Participants
|
86 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
44 participants
n=5 Participants
|
67 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
216 participants
n=5 Participants
|
211 participants
n=7 Participants
|
427 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
230 participants
n=5 Participants
|
232 participants
n=7 Participants
|
462 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
59 participants
n=5 Participants
|
67 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
109 participants
n=5 Participants
|
109 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
98 participants
n=5 Participants
|
79 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
243 participants
n=5 Participants
|
230 participants
n=7 Participants
|
473 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
106 participants
n=5 Participants
|
103 participants
n=7 Participants
|
209 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
55 participants
n=5 Participants
|
56 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
36 participants
n=5 Participants
|
22 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months from time of randomizationPopulation: (mITT) modified Intent To Treat Analysis Set
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."
Outcome measures
| Measure |
Heparin/Edoxaban Tosylate
n=4118 Participants
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 Participants
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
|
130 number or participants with an event
|
146 number or participants with an event
|
SECONDARY outcome
Timeframe: 12 months from time of randomizationPopulation: mITT Analysis set
Outcome measures
| Measure |
Heparin/Edoxaban Tosylate
n=4118 Participants
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 Participants
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
|
228 number of participants with event
|
228 number of participants with event
|
SECONDARY outcome
Timeframe: 12 months from time of randomizationPopulation: Safety Analysis Set
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.
Outcome measures
| Measure |
Heparin/Edoxaban Tosylate
n=4118 Participants
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 Participants
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
|
349 participants with an event
|
423 participants with an event
|
Adverse Events
Heparin/Edoxaban Tosylate
Serious events: 801 serious events
Other events: 816 other events
Deaths: 0 deaths
Heparin/Warfarin
Serious events: 852 serious events
Other events: 997 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Heparin/Edoxaban Tosylate
n=4118 participants at risk
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 participants at risk
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/4118 • Number of events 1
|
0.15%
6/4122 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pneumonia
|
0.85%
35/4118 • Number of events 36
|
0.75%
31/4122 • Number of events 32
|
|
Infections and infestations
Sepsis
|
0.32%
13/4118 • Number of events 13
|
0.24%
10/4122 • Number of events 10
|
|
Infections and infestations
Urinary tract infection
|
0.27%
11/4118 • Number of events 12
|
0.27%
11/4122 • Number of events 11
|
|
Infections and infestations
Bronchitis
|
0.24%
10/4118 • Number of events 10
|
0.07%
3/4122 • Number of events 3
|
|
Infections and infestations
Septic shock
|
0.19%
8/4118 • Number of events 8
|
0.12%
5/4122 • Number of events 5
|
|
Infections and infestations
Cellulitis
|
0.17%
7/4118 • Number of events 8
|
0.32%
13/4122 • Number of events 15
|
|
Infections and infestations
Diverticulitis
|
0.10%
4/4118 • Number of events 4
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
3/4118 • Number of events 3
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Erysipelas
|
0.07%
3/4118 • Number of events 4
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.07%
3/4118 • Number of events 3
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Infections and infestations
Abdominal abscess
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 2
|
|
Infections and infestations
Lobar pneumonia
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 3
|
|
Infections and infestations
Lung infection
|
0.05%
2/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Infections and infestations
Pyelonephritis
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Infections and infestations
AIDS related complication
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Abdominal wall abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Abscess jaw
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Acute tonsillitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Anal abscess
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 4
|
|
Infections and infestations
Bacteraemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Chronic sinusitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Clostridial infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Coxsackie viral infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Diabetic gangrene
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Endocarditis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Enterobacter infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Gangrene
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Helicobacter gastritis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Helicobacter infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Hepatitis C
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Hepatitis viral
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Herpes simplex
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Infected cyst
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Infection
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Infectious pleural effusion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Lower respiratory tract infection
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 4
|
|
Infections and infestations
Lung infection pseudomonal
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Lymphangitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Meningitis bacterial
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Nasopharyngitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Osteomyelitis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Otitis media
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pelvic abscess
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
Infections and infestations
Periorbital abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Peritonsillar abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pharyngeal abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pneumonia primary atypical
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Post procedural infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pseudomembranous colitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Psoas abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pulmonary sepsis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Pulpitis dental
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Renal abscess
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Respiratory tract infection viral
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Sepsis syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Staphylococcal sepsis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Typhoid fever
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Infections and infestations
Urosepsis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 2
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Abscess oral
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 3
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 3
|
|
Infections and infestations
Furuncle
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Implant site cellulitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Infected bites
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Malaria
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Paronychia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 5
|
|
Infections and infestations
Septic phlebitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.19%
8/4118 • Number of events 8
|
0.19%
8/4122 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.15%
6/4118 • Number of events 6
|
0.17%
7/4122 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.12%
5/4118 • Number of events 5
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.12%
5/4118 • Number of events 5
|
0.12%
5/4122 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.12%
5/4118 • Number of events 5
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.12%
5/4118 • Number of events 5
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.10%
4/4118 • Number of events 4
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
4/4118 • Number of events 4
|
0.19%
8/4122 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.10%
4/4118 • Number of events 4
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
4/4118 • Number of events 4
|
0.12%
5/4122 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.10%
4/4118 • Number of events 4
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.07%
3/4118 • Number of events 3
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.07%
3/4118 • Number of events 3
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
3/4118 • Number of events 3
|
0.07%
3/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.05%
2/4118 • Number of events 2
|
0.15%
6/4122 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign vaginal neoplasm
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell endometrial carcinoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
1/4118 • Number of events 3
|
0.07%
3/4122 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage III
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer extensive stage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.02%
1/4118 • Number of events 5
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.02%
1/4118 • Number of events 3
|
0.00%
0/4122
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.00%
0/4118
|
0.12%
5/4122 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage 0
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genitourinary tract neoplasm
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory myofibroblastic tumour
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to rectum
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/4118
|
0.10%
4/4122 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.22%
9/4118 • Number of events 9
|
0.32%
13/4122 • Number of events 14
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Lymphadenocyst
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Immune system disorders
Behcet's syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Immune system disorders
Polyarteritis nodosa
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.05%
2/4118 • Number of events 2
|
0.07%
3/4122 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
2/4118 • Number of events 2
|
0.07%
3/4122 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Psychiatric disorders
Agitation
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 5
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Conversion disorder
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Psychiatric disorders
Delirium
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Psychiatric disorders
Panic attack
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
12/4118 • Number of events 12
|
0.17%
7/4122 • Number of events 8
|
|
Nervous system disorders
Syncope
|
0.27%
11/4118 • Number of events 12
|
0.12%
5/4122 • Number of events 5
|
|
Nervous system disorders
Cerebral infarction
|
0.15%
6/4118 • Number of events 6
|
0.07%
3/4122 • Number of events 3
|
|
Nervous system disorders
Ischaemic stroke
|
0.12%
5/4118 • Number of events 6
|
0.12%
5/4122 • Number of events 6
|
|
Nervous system disorders
Headache
|
0.10%
4/4118 • Number of events 4
|
0.10%
4/4122 • Number of events 5
|
|
Nervous system disorders
Transient ischaemic attack
|
0.07%
3/4118 • Number of events 3
|
0.19%
8/4122 • Number of events 8
|
|
Nervous system disorders
Convulsion
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Nervous system disorders
Encephalopathy
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Nervous system disorders
Paraplegia
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Nervous system disorders
Altered state of consciousness
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cerebellar ataxia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cerebellar atrophy
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.17%
7/4122 • Number of events 7
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Complicated migraine
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Dizziness
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Drug withdrawal headache
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Epilepsy
|
0.02%
1/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Nervous system disorders
Intracranial haematoma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Loss of consciousness
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Lower motor neurone lesion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Migraine
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Multiple sclerosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Myasthenic syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Nerve compression
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Paresis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Presyncope
|
0.02%
1/4118 • Number of events 2
|
0.15%
6/4122 • Number of events 7
|
|
Nervous system disorders
Senile dementia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Spinal vascular disorder
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Nervous system disorders
Brown-Sequard syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Eye disorders
Cataract
|
0.02%
1/4118 • Number of events 1
|
0.12%
5/4122 • Number of events 8
|
|
Eye disorders
Conjunctival haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Eye disorders
Glaucoma
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
Eye disorders
Retinal vein occlusion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
1/4118 • Number of events 1
|
0.12%
5/4122 • Number of events 5
|
|
Cardiac disorders
Myocardial infarction
|
0.41%
17/4118 • Number of events 18
|
0.17%
7/4122 • Number of events 7
|
|
Cardiac disorders
Cardiac failure
|
0.34%
14/4118 • Number of events 18
|
0.17%
7/4122 • Number of events 8
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
11/4118 • Number of events 11
|
0.07%
3/4122 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
0.12%
5/4118 • Number of events 5
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
4/4118 • Number of events 4
|
0.29%
12/4122 • Number of events 12
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
4/4118 • Number of events 4
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
4/4118 • Number of events 4
|
0.24%
10/4122 • Number of events 13
|
|
Cardiac disorders
Angina unstable
|
0.07%
3/4118 • Number of events 4
|
0.10%
4/4122 • Number of events 4
|
|
Cardiac disorders
Cardiac tamponade
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Cardiac disorders
Cardiogenic shock
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Cardiac disorders
Pericardial effusion
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Cardiac disorders
Sick sinus syndrome
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Cardiac disorders
Ventricular tachycardia
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Atrial thrombosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 2
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 4
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Cor pulmonale
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Coronary artery disease
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 4
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Eosinophilic myocarditis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Intracardiac thrombus
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 4
|
|
Cardiac disorders
Nodal arrhythmia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Palpitations
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Pulseless electrical activity
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
43/4118 • Number of events 43
|
1.7%
70/4122 • Number of events 72
|
|
Vascular disorders
Arteriosclerosis
|
0.10%
4/4118 • Number of events 4
|
0.00%
0/4122
|
|
Vascular disorders
Haematoma
|
0.10%
4/4118 • Number of events 5
|
0.39%
16/4122 • Number of events 17
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
4/4118 • Number of events 4
|
0.05%
2/4122 • Number of events 2
|
|
Vascular disorders
Aortic aneurysm
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Vascular disorders
Venous insufficiency
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Vascular disorders
Hypertension
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Vascular disorders
Post thrombotic syndrome
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Vascular disorders
Aortic stenosis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Arterial thrombosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Arterial thrombosis limb
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Embolism venous
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Femoral artery embolism
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Haemodynamic instability
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Haemorrhagic infarction
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Hypotension
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
May-Thurner syndrome
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Peripheral embolism
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Peripheral ischaemia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Shock
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Subclavian artery embolism
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Varicose ulceration
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Vascular occlusion
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
Vascular disorders
Vasculitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Venous thrombosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Vascular disorders
Angiopathy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
64/4118 • Number of events 64
|
1.7%
69/4122 • Number of events 73
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
16/4118 • Number of events 16
|
0.15%
6/4122 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.27%
11/4118 • Number of events 18
|
0.34%
14/4122 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.17%
7/4118 • Number of events 7
|
0.10%
4/4122 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
6/4118 • Number of events 6
|
0.17%
7/4122 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
5/4118 • Number of events 5
|
0.15%
6/4122 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
4/4118 • Number of events 4
|
0.10%
4/4122 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
4/4118 • Number of events 5
|
0.15%
6/4122 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
4/4118 • Number of events 5
|
0.05%
2/4122 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
3/4118 • Number of events 3
|
0.07%
3/4122 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.05%
2/4118 • Number of events 2
|
0.19%
8/4122 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
15/4118 • Number of events 18
|
0.29%
12/4122 • Number of events 12
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.27%
11/4118 • Number of events 11
|
0.22%
9/4122 • Number of events 9
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
6/4118 • Number of events 9
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
5/4118 • Number of events 5
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
5/4118 • Number of events 6
|
0.07%
3/4122 • Number of events 3
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
3/4118 • Number of events 3
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Haematemesis
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Ascites
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
0.05%
2/4118 • Number of events 3
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Diarrhoea
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Melaena
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Volvulus
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal mass
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Anal erosion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Anal fissure
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's disease
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Dental caries
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
6/4118 • Number of events 6
|
0.07%
3/4122 • Number of events 3
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
4/4118 • Number of events 4
|
0.07%
3/4122 • Number of events 3
|
|
Hepatobiliary disorders
Bile duct stone
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Cholangitis
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Haemobilia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis fulminant
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
3/4118 • Number of events 4
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.12%
5/4118 • Number of events 5
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
4/4118 • Number of events 4
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
4/4118 • Number of events 4
|
0.15%
6/4122 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.05%
2/4118 • Number of events 2
|
0.07%
3/4122 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
CREST syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.29%
12/4118 • Number of events 13
|
0.61%
25/4122 • Number of events 25
|
|
Renal and urinary disorders
Renal failure acute
|
0.19%
8/4118 • Number of events 8
|
0.17%
7/4122 • Number of events 8
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
3/4118 • Number of events 3
|
0.07%
3/4122 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Renal and urinary disorders
Hydronephrosis
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Renal and urinary disorders
Renal failure
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Bladder mass
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
IgA nephropathy
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Renal colic
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Renal and urinary disorders
Renal impairment
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Pregnancy, puerperium and perinatal conditions
Complication of pregnancy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.22%
9/4118 • Number of events 10
|
0.07%
3/4122 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.12%
5/4118 • Number of events 5
|
0.12%
5/4122 • Number of events 6
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Reproductive system and breast disorders
Prostatitis
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.05%
2/4118 • Number of events 2
|
0.07%
3/4122 • Number of events 3
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine mass
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal lesion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Breast haemorrhage
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Congenital, familial and genetic disorders
Haemangioma congenital
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Chest pain
|
0.44%
18/4118 • Number of events 19
|
0.24%
10/4122 • Number of events 11
|
|
General disorders
Death
|
0.24%
10/4118 • Number of events 10
|
0.22%
9/4122 • Number of events 9
|
|
General disorders
Non-cardiac chest pain
|
0.19%
8/4118 • Number of events 8
|
0.15%
6/4122 • Number of events 6
|
|
General disorders
Oedema peripheral
|
0.17%
7/4118 • Number of events 7
|
0.10%
4/4122 • Number of events 4
|
|
General disorders
Multi-organ failure
|
0.07%
3/4118 • Number of events 3
|
0.05%
2/4122 • Number of events 2
|
|
General disorders
Device dislocation
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
General disorders
Fatigue
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
General disorders
Inflammation
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Pain
|
0.05%
2/4118 • Number of events 2
|
0.10%
4/4122 • Number of events 4
|
|
General disorders
Sudden death
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
General disorders
Adverse drug reaction
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Cyst
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Device leakage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Device occlusion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
General physical health deterioration
|
0.02%
1/4118 • Number of events 2
|
0.00%
0/4122
|
|
General disorders
Granuloma
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Injection site haematoma
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Injection site haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Metaplasia
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Multi-organ disorder
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Necrosis
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Oedema
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
General disorders
Pyrexia
|
0.02%
1/4118 • Number of events 1
|
0.15%
6/4122 • Number of events 7
|
|
General disorders
Accidental death
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Drug intolerance
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Injection site pain
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
General disorders
Therapeutic response increased
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
General disorders
Thrombosis in device
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
0.29%
12/4118 • Number of events 13
|
1.9%
79/4122 • Number of events 89
|
|
Investigations
Hepatic enzyme increased
|
0.12%
5/4118 • Number of events 5
|
0.07%
3/4122 • Number of events 3
|
|
Investigations
Liver function test abnormal
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Investigations
Transaminases increased
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Weight decreased
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Investigations
Blood creatinine increased
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Investigations
Coagulation test abnormal
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Investigations
Creatinine renal clearance decreased
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Pulmonary arterial pressure increased
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.17%
7/4118 • Number of events 7
|
0.12%
5/4122 • Number of events 5
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
6/4118 • Number of events 6
|
0.10%
4/4122 • Number of events 4
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
5/4118 • Number of events 5
|
0.17%
7/4122 • Number of events 7
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.12%
5/4118 • Number of events 5
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
5/4118 • Number of events 5
|
0.12%
5/4122 • Number of events 5
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.12%
5/4118 • Number of events 5
|
0.10%
4/4122 • Number of events 4
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.07%
3/4118 • Number of events 3
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.07%
3/4118 • Number of events 3
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
3/4118 • Number of events 3
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Laceration
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
2/4118 • Number of events 2
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
2/4118 • Number of events 2
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.05%
2/4118 • Number of events 2
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.02%
1/4118 • Number of events 1
|
0.12%
5/4122 • Number of events 5
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/4118 • Number of events 1
|
0.10%
4/4122 • Number of events 5
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.02%
1/4118 • Number of events 1
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.02%
1/4118 • Number of events 1
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/4118 • Number of events 1
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4118
|
0.05%
2/4122 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4118
|
0.15%
6/4122 • Number of events 6
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/4118
|
0.07%
3/4122 • Number of events 3
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 3
|
|
Surgical and medical procedures
Abortion induced
|
0.07%
3/4118 • Number of events 3
|
0.10%
4/4122 • Number of events 4
|
|
Social circumstances
Prosthesis user
|
0.02%
1/4118 • Number of events 1
|
0.00%
0/4122
|
|
Social circumstances
Homicide
|
0.00%
0/4118
|
0.02%
1/4122 • Number of events 1
|
Other adverse events
| Measure |
Heparin/Edoxaban Tosylate
n=4118 participants at risk
edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
|
Heparin/Warfarin
n=4122 participants at risk
low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
|
|---|---|---|
|
Infections and infestations
nasopharyngitis
|
6.3%
260/4118 • Number of events 319
|
6.2%
254/4122 • Number of events 316
|
|
Nervous system disorders
headache
|
6.0%
248/4118 • Number of events 291
|
5.0%
208/4122 • Number of events 287
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
5.7%
235/4118 • Number of events 276
|
5.3%
218/4122 • Number of events 241
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
5.1%
208/4118 • Number of events 263
|
6.0%
246/4122 • Number of events 353
|
|
Investigations
international normalised ratio increased
|
0.66%
27/4118 • Number of events 33
|
6.7%
275/4122 • Number of events 386
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.
- Publication restrictions are in place
Restriction type: OTHER