Trial Outcomes & Findings for Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035) (NCT NCT00705614)
NCT ID: NCT00705614
Last Updated: 2017-03-22
Results Overview
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Recruitment status
COMPLETED
Target enrollment
2662 participants
Primary outcome timeframe
Up to 5 Years
Results posted on
2017-03-22
Participant Flow
The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
Participant milestones
| Measure |
Remicade
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
|
Standard Therapy Group
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter.
|
|---|---|---|
|
Initial Intervention
STARTED
|
1541
|
1121
|
|
Initial Intervention
COMPLETED
|
1023
|
800
|
|
Initial Intervention
NOT COMPLETED
|
518
|
321
|
|
Switch to Remicade
STARTED
|
0
|
298
|
|
Switch to Remicade
COMPLETED
|
0
|
249
|
|
Switch to Remicade
NOT COMPLETED
|
0
|
49
|
Reasons for withdrawal
| Measure |
Remicade
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
|
Standard Therapy Group
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter.
|
|---|---|---|
|
Initial Intervention
Adverse Event
|
40
|
21
|
|
Initial Intervention
Lost to Follow-up
|
310
|
191
|
|
Initial Intervention
Withdrawal by Subject
|
114
|
71
|
|
Initial Intervention
Administrative Reason
|
51
|
38
|
|
Initial Intervention
Status completion unknown
|
3
|
0
|
|
Switch to Remicade
Adverse Event
|
0
|
5
|
|
Switch to Remicade
Lost to Follow-up
|
0
|
23
|
|
Switch to Remicade
Withdrawal by Subject
|
0
|
12
|
|
Switch to Remicade
Administrative Reason
|
0
|
9
|
Baseline Characteristics
Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)
Baseline characteristics by cohort
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
|
Standard Therapy Group
n=1121 Participants
The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
|
Total
n=2662 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
All Participants
|
36.1 Years
STANDARD_DEVIATION 12.90 • n=99 Participants
|
37.5 Years
STANDARD_DEVIATION 12.86 • n=107 Participants
|
36.7 Years
STANDARD_DEVIATION 12.90 • n=206 Participants
|
|
Age, Continuous
Switched to Remicade
|
NA Years
STANDARD_DEVIATION NA • n=99 Participants
|
36.7 Years
STANDARD_DEVIATION 12.3 • n=107 Participants
|
36.7 Years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex/Gender, Customized
Female (All Participants)
|
935 Participants
n=99 Participants
|
677 Participants
n=107 Participants
|
1612 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male (All Participants)
|
606 Participants
n=99 Participants
|
444 Participants
n=107 Participants
|
1050 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female (Switched to Remicade)
|
NA Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male (Switched to Remicade)
|
NA Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With Serious Infections
|
132 Participants
|
47 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With Infusion-Related Reactions/Hypersensitivity
|
173 Participants
|
1 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participant fatalities was evaluated throughout the study.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participant Fatalities
|
30 Participants
|
14 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With New or Worsening Congestive Heart Failure
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With Demyelinating Neurological Disorders
|
4 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With Hematologic Conditions
|
50 Participants
|
11 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With Lymphoproliferative Disorders/Malignancies
|
49 Participants
|
21 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 1 (Baseline; n=1526, 1116, 0)
|
4.3 Score on a Scale
Standard Deviation 1.33
|
3.9 Score on a Scale
Standard Deviation 1.38
|
NA Score on a Scale
Standard Deviation NA
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 2 (n=1344, 903, 95)
|
3.3 Score on a Scale
Standard Deviation 1.44
|
3.3 Score on a Scale
Standard Deviation 1.44
|
3.9 Score on a Scale
Standard Deviation 1.49
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 3 (n=1280, 809, 146)
|
3.2 Score on a Scale
Standard Deviation 1.41
|
3.1 Score on a Scale
Standard Deviation 1.40
|
3.6 Score on a Scale
Standard Deviation 1.41
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 4 (n=1217, 755, 162)
|
3.2 Score on a Scale
Standard Deviation 1.43
|
3.0 Score on a Scale
Standard Deviation 1.38
|
3.5 Score on a Scale
Standard Deviation 1.45
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 5 (n=1160, 704, 184)
|
3.1 Score on a Scale
Standard Deviation 1.44
|
3.1 Score on a Scale
Standard Deviation 1.42
|
3.2 Score on a Scale
Standard Deviation 1.52
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 6 (n=1110, 649, 202)
|
3.1 Score on a Scale
Standard Deviation 1.43
|
3.0 Score on a Scale
Standard Deviation 1.41
|
3.4 Score on a Scale
Standard Deviation 1.44
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 7 (n=1046, 606, 212)
|
3.1 Score on a Scale
Standard Deviation 1.47
|
3.0 Score on a Scale
Standard Deviation 1.41
|
3.3 Score on a Scale
Standard Deviation 1.42
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 8 (n=1044, 573, 221)
|
3.1 Score on a Scale
Standard Deviation 1.46
|
3.0 Score on a Scale
Standard Deviation 1.44
|
3.2 Score on a Scale
Standard Deviation 1.43
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 9 (n=999, 544, 223)
|
3.1 Score on a Scale
Standard Deviation 1.45
|
2.9 Score on a Scale
Standard Deviation 1.41
|
3.2 Score on a Scale
Standard Deviation 1.50
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 10 (n=963, 520, 227)
|
3.0 Score on a Scale
Standard Deviation 1.42
|
2.8 Score on a Scale
Standard Deviation 1.44
|
3.1 Score on a Scale
Standard Deviation 1.38
|
|
Participant Assessment of Overall Health Status By Study Visit
Visit 11 (n=956, 527, 235)
|
3.0 Score on a Scale
Standard Deviation 1.41
|
2.8 Score on a Scale
Standard Deviation 1.43
|
3.1 Score on a Scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 1 (Baseline; n=1505, 1106, 0)
|
8.2 Score on a Scale
Standard Deviation 5.36
|
6.2 Score on a Scale
Standard Deviation 4.94
|
NA Score on a Scale
Standard Deviation NA
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 2 (n=1320, 876, 91)
|
4.1 Score on a Scale
Standard Deviation 4.13
|
3.8 Score on a Scale
Standard Deviation 3.84
|
6.0 Score on a Scale
Standard Deviation 5.28
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 3 (n=1250, 785, 143)
|
3.7 Score on a Scale
Standard Deviation 3.87
|
3.5 Score on a Scale
Standard Deviation 3.64
|
4.4 Score on a Scale
Standard Deviation 4.05
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 4 (n=1196, 742, 159)
|
3.8 Score on a Scale
Standard Deviation 4.01
|
3.2 Score on a Scale
Standard Deviation 3.56
|
4.8 Score on a Scale
Standard Deviation 4.47
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 5 (n=1127, 692, 181)
|
3.7 Score on a Scale
Standard Deviation 3.95
|
3.4 Score on a Scale
Standard Deviation 3.51
|
4.9 Score on a Scale
Standard Deviation 5.81
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 6 (n=1070, 647, 199)
|
3.6 Score on a Scale
Standard Deviation 4.00
|
3.1 Score on a Scale
Standard Deviation 3.39
|
4.5 Score on a Scale
Standard Deviation 4.29
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 7 (n=1023, 592, 209)
|
3.6 Score on a Scale
Standard Deviation 4.00
|
3.0 Score on a Scale
Standard Deviation 3.36
|
4.1 Score on a Scale
Standard Deviation 4.43
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 8 (n=1015, 562, 224)
|
3.6 Score on a Scale
Standard Deviation 3.97
|
3.2 Score on a Scale
Standard Deviation 3.63
|
4.1 Score on a Scale
Standard Deviation 4.69
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 9 (n=953, 546, 219)
|
3.6 Score on a Scale
Standard Deviation 4.50
|
2.9 Score on a Scale
Standard Deviation 2.90
|
4.4 Score on a Scale
Standard Deviation 5.23
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 10 (n=936, 526, 225)
|
3.4 Score on a Scale
Standard Deviation 4.23
|
2.7 Score on a Scale
Standard Deviation 3.38
|
4.3 Score on a Scale
Standard Deviation 4.66
|
|
The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
Visit 11 (n=918, 525, 238)
|
3.4 Score on a Scale
Standard Deviation 3.93
|
2.7 Score on a Scale
Standard Deviation 3.44
|
4.2 Score on a Scale
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Work/Daily Activity Status Score By Study Visit
Visit 1 (Baseline; n=1496, 1108, 0)
|
5.9 Score on a Scale
Standard Deviation 2.61
|
4.9 Score on a Scale
Standard Deviation 2.83
|
NA Score on a Scale
Standard Deviation NA
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Work/Daily Activity Status Score By Study Visit
Visit 2 (n=1316, 895, 94)
|
4.2 Score on a Scale
Standard Deviation 2.86
|
3.7 Score on a Scale
Standard Deviation 2.79
|
5.5 Score on a Scale
Standard Deviation 2.81
|
|
Work/Daily Activity Status Score By Study Visit
Visit 3 (n=1235, 797, 143)
|
3.8 Score on a Scale
Standard Deviation 2.76
|
3.2 Score on a Scale
Standard Deviation 2.77
|
4.8 Score on a Scale
Standard Deviation 2.94
|
|
Work/Daily Activity Status Score By Study Visit
Visit 4 (n=1192, 738, 159)
|
3.6 Score on a Scale
Standard Deviation 2.79
|
2.9 Score on a Scale
Standard Deviation 2.60
|
4.3 Score on a Scale
Standard Deviation 2.95
|
|
Work/Daily Activity Status Score By Study Visit
Visit 5 (n=1128, 694, 179)
|
3.4 Score on a Scale
Standard Deviation 2.76
|
3.0 Score on a Scale
Standard Deviation 2.63
|
4.0 Score on a Scale
Standard Deviation 2.89
|
|
Work/Daily Activity Status Score By Study Visit
Visit 6 (n=1077, 638, 201)
|
3.3 Score on a Scale
Standard Deviation 2.75
|
2.7 Score on a Scale
Standard Deviation 2.56
|
3.9 Score on a Scale
Standard Deviation 2.87
|
|
Work/Daily Activity Status Score By Study Visit
Visit 7 (n=1030, 601, 207)
|
3.2 Score on a Scale
Standard Deviation 2.70
|
2.8 Score on a Scale
Standard Deviation 2.62
|
3.6 Score on a Scale
Standard Deviation 2.85
|
|
Work/Daily Activity Status Score By Study Visit
Visit 8 (n=1025, 571, 221)
|
3.3 Score on a Scale
Standard Deviation 2.75
|
2.7 Score on a Scale
Standard Deviation 2.59
|
3.5 Score on a Scale
Standard Deviation 2.74
|
|
Work/Daily Activity Status Score By Study Visit
Visit 9 (n=982, 542, 222)
|
3.3 Score on a Scale
Standard Deviation 2.75
|
2.6 Score on a Scale
Standard Deviation 2.46
|
3.5 Score on a Scale
Standard Deviation 2.78
|
|
Work/Daily Activity Status Score By Study Visit
Visit 10 (n=934, 514, 225)
|
3.1 Score on a Scale
Standard Deviation 2.66
|
2.4 Score on a Scale
Standard Deviation 2.53
|
3.6 Score on a Scale
Standard Deviation 2.71
|
|
Work/Daily Activity Status Score By Study Visit
Visit 11 (n=925, 521, 235)
|
3.2 Score on a Scale
Standard Deviation 2.67
|
2.4 Score on a Scale
Standard Deviation 2.44
|
3.6 Score on a Scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants with a draining fistula was evaluated at each study visit.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 1 (Baseline; n=1541, 1120, 0)
|
349 Participants
|
96 Participants
|
NA Participants
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 2 (n=1420, 920, 100)
|
211 Participants
|
51 Participants
|
16 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 3 (n=1334, 827, 152)
|
170 Participants
|
41 Participants
|
19 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 4 (n=1285, 779, 168)
|
146 Participants
|
31 Participants
|
12 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 5 (n=1221, 714, 188)
|
125 Participants
|
29 Participants
|
15 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 6 (n=1169, 666, 208)
|
114 Participants
|
26 Participants
|
15 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 7 (n=1110, 615, 219)
|
97 Participants
|
31 Participants
|
15 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 8 (n=1097, 588, 233)
|
105 Participants
|
23 Participants
|
16 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 9 (n=1046, 562, 229)
|
98 Participants
|
32 Participants
|
15 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 10 (n=1030, 535, 235)
|
85 Participants
|
15 Participants
|
20 Participants
|
|
Number of Participants With a Draining Fistula By Study Visit
Visit 11 (n=1006, 541, 248)
|
87 Participants
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 1 (Baseline; n=1539, 1121, 0)
|
0.7 Hospital Stays
Standard Deviation 1.25
|
0.5 Hospital Stays
Standard Deviation 0.81
|
NA Hospital Stays
Standard Deviation NA
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 2 (n=1418, 920, 100)
|
0.3 Hospital Stays
Standard Deviation 0.87
|
0.2 Hospital Stays
Standard Deviation 0.50
|
0.5 Hospital Stays
Standard Deviation 0.76
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 3 (n=1334, 827, 152)
|
0.3 Hospital Stays
Standard Deviation 0.92
|
0.1 Hospital Stays
Standard Deviation 0.38
|
0.4 Hospital Stays
Standard Deviation 0.86
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 4 (n=1285, 779, 168)
|
0.2 Hospital Stays
Standard Deviation 0.56
|
0.2 Hospital Stays
Standard Deviation 3.08
|
0.2 Hospital Stays
Standard Deviation 0.67
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 5 (n=1221, 714, 188)
|
0.1 Hospital Stays
Standard Deviation 0.54
|
0.1 Hospital Stays
Standard Deviation 0.28
|
0.3 Hospital Stays
Standard Deviation 0.72
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 6 (n=1170, 665, 208)
|
0.1 Hospital Stays
Standard Deviation 0.66
|
0.1 Hospital Stays
Standard Deviation 0.33
|
0.1 Hospital Stays
Standard Deviation 0.49
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 7 (n=1111, 615, 219)
|
0.1 Hospital Stays
Standard Deviation 0.40
|
0.1 Hospital Stays
Standard Deviation 0.43
|
0.2 Hospital Stays
Standard Deviation 0.55
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 8 (n=1099, 589, 233)
|
0.1 Hospital Stays
Standard Deviation 0.76
|
0.1 Hospital Stays
Standard Deviation 0.42
|
0.1 Hospital Stays
Standard Deviation 0.49
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 9 (n=1046, 562, 229)
|
0.1 Hospital Stays
Standard Deviation 0.68
|
0.1 Hospital Stays
Standard Deviation 0.50
|
0.1 Hospital Stays
Standard Deviation 0.31
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 10 (n=1031, 535, 235)
|
0.1 Hospital Stays
Standard Deviation 0.46
|
0.1 Hospital Stays
Standard Deviation 0.42
|
0.1 Hospital Stays
Standard Deviation 0.44
|
|
Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 11 (n=1006, 541, 248)
|
0.1 Hospital Stays
Standard Deviation 0.35
|
0.1 Hospital Stays
Standard Deviation 2.59
|
0.1 Hospital Stays
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 1 (Baseline; n=657,418 ,0)
|
12.2 Days
Standard Deviation 13.73
|
10.8 Days
Standard Deviation 10.93
|
NA Days
Standard Deviation NA
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 2 (n=304,126, 33)
|
14.4 Days
Standard Deviation 17.81
|
12.0 Days
Standard Deviation 14.26
|
13.0 Days
Standard Deviation 12.23
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 3 (n=216, 58, 35)
|
14.2 Days
Standard Deviation 16.83
|
9.4 Days
Standard Deviation 7.49
|
13.5 Days
Standard Deviation 13.65
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 4 (n=151, 60, 24)
|
12.6 Days
Standard Deviation 15.23
|
8.5 Days
Standard Deviation 11.87
|
9.1 Days
Standard Deviation 10.82
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 5 (n=105, 35, 34)
|
11.7 Days
Standard Deviation 13.02
|
9.8 Days
Standard Deviation 9.49
|
7.1 Days
Standard Deviation 6.21
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 6 (n=107, 49, 19)
|
10.8 Days
Standard Deviation 17.33
|
13.7 Days
Standard Deviation 27.34
|
18.3 Days
Standard Deviation 17.81
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 7 (n=109, 45, 25)
|
10.6 Days
Standard Deviation 14.41
|
10.2 Days
Standard Deviation 10.63
|
10.0 Days
Standard Deviation 11.33
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 8 (n=98, 29, 23)
|
9.5 Days
Standard Deviation 9.04
|
16.3 Days
Standard Deviation 15.52
|
14.7 Days
Standard Deviation 17.29
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 9 (n=80, 38, 17)
|
12.4 Days
Standard Deviation 14.44
|
6.9 Days
Standard Deviation 5.77
|
10.7 Days
Standard Deviation 17.20
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 10 (n=85, 29, 27)
|
10.1 Days
Standard Deviation 12.02
|
8.0 Days
Standard Deviation 5.41
|
9.0 Days
Standard Deviation 6.40
|
|
Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
Visit 11 (n=63, 19, 18)
|
11.4 Days
Standard Deviation 13.24
|
8.7 Days
Standard Deviation 10.64
|
18.1 Days
Standard Deviation 31.57
|
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.
The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.
Outcome measures
| Measure |
Remicade
n=1541 Participants
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Standard Therapy
n=1121 Participants
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Switched to Remicade
n=298 Participants
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 1 (Basline; n=660, 419, 0)
|
171 Surgical Procedures
|
81 Surgical Procedures
|
NA Surgical Procedures
Due to the study design, participants would not have switched to Remicade at the Baseline visit.
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 2 (n=304, 126, 33)
|
135 Surgical Procedures
|
51 Surgical Procedures
|
7 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 3 (n=217, 57, 36)
|
121 Surgical Procedures
|
23 Surgical Procedures
|
12 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 4 (n=153, 60, 24)
|
68 Surgical Procedures
|
16 Surgical Procedures
|
8 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 5 (n=106, 36, 34)
|
50 Surgical Procedures
|
14 Surgical Procedures
|
14 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 6 (n=108, 49, 19)
|
49 Surgical Procedures
|
21 Surgical Procedures
|
11 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 7 (n=109, 45, 25)
|
48 Surgical Procedures
|
20 Surgical Procedures
|
6 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 8 (n=98, 29, 23)
|
43 Surgical Procedures
|
12 Surgical Procedures
|
7 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 9 (n=82, 38, 17)
|
38 Surgical Procedures
|
13 Surgical Procedures
|
8 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 10 (n=85, 29, 27)
|
38 Surgical Procedures
|
13 Surgical Procedures
|
8 Surgical Procedures
|
|
Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
Visit 11 (n=63, 19, 18)
|
34 Surgical Procedures
|
6 Surgical Procedures
|
8 Surgical Procedures
|
Adverse Events
Standard Therapy
Serious events: 391 serious events
Other events: 173 other events
Deaths: 0 deaths
Remicade
Serious events: 792 serious events
Other events: 441 other events
Deaths: 0 deaths
Switched to Remicade
Serious events: 136 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Therapy
n=1121 participants at risk
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Remicade
n=1541 participants at risk
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Switched to Remicade
n=298 participants at risk
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL NEOPLASM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL TRACT ADENOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
IGA NEPHROPATHY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
NEPHRITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.45%
5/1121 • Number of events 8 • Up to 5 Years
|
0.65%
10/1541 • Number of events 11 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
PNEUMATURIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
POSTRENAL FAILURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
RENAL COLIC
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
RENAL MASS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
URETHRAL FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
BARTHOLIN'S CYST
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
BARTHOLINITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
BREAST MASS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.52%
8/1541 • Number of events 9 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
INFERTILITY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
OVARIAN DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
PERINEAL FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOPROLIFERATIVE DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
UTERINE MALPOSITION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Reproductive system and breast disorders
VAGINAL FISTULA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPNEUMOPATHY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PERITONEAL NEOPLASM
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC LYMPHOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER METASTATIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN ADENOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL INTESTINE ADENOCARCINOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL INTESTINE CARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID ADENOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
URETERIC CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER STAGE 0
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
CEREBRAL ARTERY THROMBOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
CEREBRAL ATROPHY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Nervous system disorders
COMPLEX REGIONAL PAIN SYNDROME
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
MIGRAINE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
NERVE ROOT COMPRESSION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
OPTIC NEURITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
PARALYSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
PYRAMIDAL TRACT SYNDROME
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
SCIATICA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
SYNCOPE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
BREECH PRESENTATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
DELIVERY
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL GROWTH RESTRICTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
NORMAL LABOUR
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
PLACENTAL DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
POSTPARTUM HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.27%
3/1121 • Number of events 4 • Up to 5 Years
|
1.3%
20/1541 • Number of events 20 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE DELIVERY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
TWIN PREGNANCY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
UMBILICAL GRANULOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Pregnancy, puerperium and perinatal conditions
UTERINE CONTRACTIONS ABNORMAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
AGGRESSION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
DEPRESSION
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.39%
6/1541 • Number of events 9 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
DYSTHYMIC DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
ENCOPRESIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
POST-TRAUMATIC STRESS DISORDER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
SOMATISATION DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
HYPERTENSION
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
ISCHAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
SUBCLAVIAN VEIN THROMBOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
THROMBOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.39%
6/1541 • Number of events 7 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD POLYP
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
ACUTE FEBRILE NEUTROPHILIC DERMATOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DERMAL CYST
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
HENOCH-SCHONLEIN PURPURA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
PYODERMA GANGRENOSUM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Social circumstances
FAMILIAL RISK FACTOR
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Social circumstances
PREGNANCY OF PARTNER
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
CAESAREAN SECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
COLECTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
COLOSTOMY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
COLOSTOMY CLOSURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
ENTEROSTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
FISTULA REPAIR
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
HAEMATOPOIETIC STEM CELL MOBILISATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
HOSPITALISATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
ILEECTOMY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
ILEOSTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
ILEOSTOMY CLOSURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
INTESTINAL ANASTOMOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
INTESTINAL RESECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
LIVER TRANSPLANT
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
MACROPHAGE ACTIVATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
MITRAL VALVE REPLACEMENT
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
POLYPECTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
SMALL INTESTINAL RESECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Surgical and medical procedures
SURGERY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Surgical and medical procedures
THYROIDECTOMY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
AORTIC DISSECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
AORTIC OCCLUSION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
TRISMUS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ABDOMINAL NEOPLASM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LEUKAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN SOFT TISSUE NEOPLASM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN UTERINE NEOPLASM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOID LEUKAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.45%
5/1121 • Number of events 6 • Up to 5 Years
|
0.58%
9/1541 • Number of events 11 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Blood and lymphatic system disorders
ANAEMIA HAEMOLYTIC AUTOIMMUNE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
ANAEMIA VITAMIN B12 DEFICIENCY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
HAEMOLYTIC URAEMIC SYNDROME
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Blood and lymphatic system disorders
THYMUS DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.27%
3/1121 • Number of events 4 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
PLEUROPERICARDITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
CONGENITAL ANOMALY IN OFFSPRING
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
ENCEPHALOCELE
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
HAEMANGIOMA CONGENITAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
HIP DYSPLASIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
PRETERNATURAL ANUS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Congenital, familial and genetic disorders
PYLORIC STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Endocrine disorders
ADRENOCORTICAL INSUFFICIENCY ACUTE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Endocrine disorders
GOITRE
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Eye disorders
CATARACT
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Eye disorders
COLOUR BLINDNESS ACQUIRED
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Eye disorders
UVEITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.6%
29/1121 • Number of events 30 • Up to 5 Years
|
2.7%
42/1541 • Number of events 49 • Up to 5 Years
|
3.0%
9/298 • Number of events 10 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ACUTE ABDOMEN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.98%
11/1121 • Number of events 18 • Up to 5 Years
|
3.0%
47/1541 • Number of events 57 • Up to 5 Years
|
1.3%
4/298 • Number of events 5 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL SKIN TAGS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL SPHINCTER ATONY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANAL STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANOGENITAL DYSPLASIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ANOVULVAR FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ASCITES
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
BILE ACID MALABSORPTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
COLITIS
|
0.54%
6/1121 • Number of events 6 • Up to 5 Years
|
0.52%
8/1541 • Number of events 8 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
COLONIC STENOSIS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.52%
8/1541 • Number of events 9 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
11.7%
131/1121 • Number of events 164 • Up to 5 Years
|
19.3%
298/1541 • Number of events 460 • Up to 5 Years
|
15.8%
47/298 • Number of events 67 • Up to 5 Years
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.54%
6/1121 • Number of events 6 • Up to 5 Years
|
0.71%
11/1541 • Number of events 12 • Up to 5 Years
|
1.3%
4/298 • Number of events 4 • Up to 5 Years
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
DUODENAL STENOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ENTEROCOLONIC FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.27%
3/1121 • Number of events 6 • Up to 5 Years
|
0.45%
7/1541 • Number of events 9 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
FAECALOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
FLATULENCE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTRODUODENAL ULCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DYSPLASIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 7 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HYPOMOTILITY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL STENOSIS
|
0.62%
7/1121 • Number of events 8 • Up to 5 Years
|
0.58%
9/1541 • Number of events 15 • Up to 5 Years
|
1.0%
3/298 • Number of events 3 • Up to 5 Years
|
|
Gastrointestinal disorders
GASTROINTESTINAL TOXICITY
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
HERNIAL EVENTRATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ILEAL FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ILEAL STENOSIS
|
1.8%
20/1121 • Number of events 21 • Up to 5 Years
|
2.7%
41/1541 • Number of events 45 • Up to 5 Years
|
3.0%
9/298 • Number of events 10 • Up to 5 Years
|
|
Gastrointestinal disorders
ILEITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
ILEUS
|
1.1%
12/1121 • Number of events 13 • Up to 5 Years
|
1.1%
17/1541 • Number of events 19 • Up to 5 Years
|
1.3%
4/298 • Number of events 5 • Up to 5 Years
|
|
Gastrointestinal disorders
INFLAMMATORY BOWEL DISEASE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL ANGINA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL FISTULA
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL INFARCTION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.80%
9/1121 • Number of events 10 • Up to 5 Years
|
2.3%
36/1541 • Number of events 44 • Up to 5 Years
|
1.3%
4/298 • Number of events 4 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL POLYP
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.71%
8/1121 • Number of events 8 • Up to 5 Years
|
0.97%
15/1541 • Number of events 16 • Up to 5 Years
|
1.0%
3/298 • Number of events 3 • Up to 5 Years
|
|
Gastrointestinal disorders
INTUSSUSCEPTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
JEJUNAL STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
Gastrointestinal disorders
LARGE INTESTINAL HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
LARGE INTESTINAL ULCER
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.58%
9/1541 • Number of events 9 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Gastrointestinal disorders
MALABSORPTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
MECHANICAL ILEUS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
MESENTERIC OCCLUSION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
MESENTERIC VASCULAR INSUFFICIENCY
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
NAUSEA
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.45%
5/1121 • Number of events 5 • Up to 5 Years
|
0.39%
6/1541 • Number of events 8 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 4 • Up to 5 Years
|
|
Gastrointestinal disorders
PEPTIC ULCER HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
POUCHITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/1121 • Up to 5 Years
|
0.32%
5/1541 • Number of events 7 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
PROCTOCOLITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
RECTAL STENOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.71%
8/1121 • Number of events 9 • Up to 5 Years
|
1.0%
16/1541 • Number of events 17 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
SMALL INTESTINAL STENOSIS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
SUBILEUS
|
0.98%
11/1121 • Number of events 13 • Up to 5 Years
|
1.1%
17/1541 • Number of events 21 • Up to 5 Years
|
2.0%
6/298 • Number of events 7 • Up to 5 Years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Gastrointestinal disorders
VOMITING
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.65%
10/1541 • Number of events 10 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
General disorders
ADHESION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
ADVERSE DRUG REACTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
ASTHENIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
General disorders
CARDIAC DEATH
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
CONDITION AGGRAVATED
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
CYST
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
DEATH NEONATAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
DRUG INEFFECTIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
DRUG INTOLERANCE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
FATIGUE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/1121 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
HERNIA
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
General disorders
IMPAIRED HEALING
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
INFLAMMATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
LOCALISED OEDEMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
MALAISE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
General disorders
MEDICAL DEVICE COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
NECROSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
General disorders
OEDEMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
PYREXIA
|
0.80%
9/1121 • Number of events 10 • Up to 5 Years
|
1.0%
16/1541 • Number of events 19 • Up to 5 Years
|
1.3%
4/298 • Number of events 4 • Up to 5 Years
|
|
General disorders
SEROSITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLANGITIS SCLEROSING
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLECYSTOCHOLANGITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.45%
5/1121 • Number of events 5 • Up to 5 Years
|
0.52%
8/1541 • Number of events 8 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
CHOLESTASIS OF PREGNANCY
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
HEPATITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
HEPATORENAL FAILURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
JAUNDICE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
ANAPHYLACTOID REACTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.71%
11/1541 • Number of events 11 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/1121 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
INTESTINE TRANSPLANT REJECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Immune system disorders
SERUM SICKNESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Immune system disorders
TYPE IV HYPERSENSITIVITY REACTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.62%
7/1121 • Number of events 8 • Up to 5 Years
|
1.3%
20/1541 • Number of events 23 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ABSCESS
|
0.89%
10/1121 • Number of events 11 • Up to 5 Years
|
0.65%
10/1541 • Number of events 10 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
1.0%
3/298 • Number of events 3 • Up to 5 Years
|
|
Infections and infestations
ABSCESS SWEAT GLAND
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ACINETOBACTER BACTERAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
AMOEBIC DYSENTERY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ANAL ABSCESS
|
1.5%
17/1121 • Number of events 21 • Up to 5 Years
|
4.0%
61/1541 • Number of events 83 • Up to 5 Years
|
2.7%
8/298 • Number of events 12 • Up to 5 Years
|
|
Infections and infestations
APPENDICITIS
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BACTERAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BARTHOLIN'S ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CHLAMYDIAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CYTOMEGALOVIRUS COLITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
CYTOMEGALOVIRUS HEPATITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.45%
5/1121 • Number of events 5 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
ENDOCARDITIS STAPHYLOCOCCAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ERYSIPELAS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
FEBRILE INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GASTROENTERITIS
|
0.80%
9/1121 • Number of events 9 • Up to 5 Years
|
1.0%
16/1541 • Number of events 16 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
GASTROENTERITIS PSEUDOMONAS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GENITAL ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
GENITOURINARY TRACT INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GIARDIASIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
GROIN ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
HAEMATOMA INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
HEPATITIS E
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
HERPES ZOSTER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
HERPES ZOSTER OPHTHALMIC
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
HORDEOLUM
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
HUMAN HERPESVIRUS 6 INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
INFECTION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
INFECTIVE THROMBOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LISTERIOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
LIVER ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
LUNG INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MENINGITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MENINGITIS LISTERIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MENINGITIS STAPHYLOCOCCAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MENINGOENCEPHALITIS BACTERIAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MYCOBACTERIAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
MYCOPLASMA INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
OVARIAN ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PAPILLOMA VIRAL INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PELVIC ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PERINEAL ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.26%
4/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.39%
6/1541 • Number of events 6 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PERITONEAL ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PERITONITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.45%
7/1541 • Number of events 8 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PILONIDAL CYST
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PNEUMONIA
|
0.45%
5/1121 • Number of events 5 • Up to 5 Years
|
0.91%
14/1541 • Number of events 15 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
POST PROCEDURAL SEPSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PSEUDOMEMBRANOUS COLITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PSOAS ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PURULENT DISCHARGE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
PYELONEPHRITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.67%
2/298 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
RECTAL ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.45%
7/1541 • Number of events 8 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
RECTOVAGINAL SEPTUM ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
RETROPERITONEAL ABSCESS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SALMONELLOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SALPINGITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SEPSIS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.45%
7/1541 • Number of events 7 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
STITCH ABSCESS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.52%
8/1541 • Number of events 8 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
TONSILLITIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
TOXOPLASMOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
TUBERCULOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Infections and infestations
TUBERCULOSIS GASTROINTESTINAL
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VAGINAL ABSCESS
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VIRAL DIARRHOEA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VIRAL PERICARDITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
VULVAL ABSCESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Infections and infestations
WOUND INFECTION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC FISTULA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC STENOSIS
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
EXPOSURE DURING PREGNANCY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
1.7%
5/298 • Number of events 5 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.45%
7/1541 • Number of events 8 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
HEPATIC HAEMATOMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
HEPATIC RUPTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.18%
2/1121 • Number of events 3 • Up to 5 Years
|
0.26%
4/1541 • Number of events 4 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
LIMB TRAUMATIC AMPUTATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POISONING
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DIARRHOEA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE FEVER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE HERNIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
PROCEDURAL SITE REACTION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.27%
3/1121 • Number of events 3 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SUBCUTANEOUS HAEMATOMA
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
SUTURE RELATED COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
BIOPSY LIVER
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
CYTOMEGALOVIRUS TEST
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
FALSE POSITIVE INVESTIGATION RESULT
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
INVESTIGATION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
NOROVIRUS TEST POSITIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
VOLUME BLOOD DECREASED
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Investigations
WEIGHT DECREASED
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.13%
2/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.71%
11/1541 • Number of events 27 • Up to 5 Years
|
1.0%
3/298 • Number of events 3 • Up to 5 Years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 4 • Up to 5 Years
|
0.34%
1/298 • Number of events 2 • Up to 5 Years
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 5 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Metabolism and nutrition disorders
OBESITY
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Metabolism and nutrition disorders
OVERWEIGHT
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Metabolism and nutrition disorders
VITAMIN K DEFICIENCY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.58%
9/1541 • Number of events 11 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.09%
1/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS ENTEROPATHIC
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS REACTIVE
|
0.00%
0/1121 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 7 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.54%
6/1121 • Number of events 6 • Up to 5 Years
|
1.1%
17/1541 • Number of events 17 • Up to 5 Years
|
0.67%
2/298 • Number of events 3 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FISTULA DISCHARGE
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.32%
5/1541 • Number of events 5 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
FRACTURE DELAYED UNION
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.18%
2/1121 • Number of events 2 • Up to 5 Years
|
0.19%
3/1541 • Number of events 3 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
METATARSALGIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
MONARTHRITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.36%
4/1121 • Number of events 4 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.00%
0/1541 • Up to 5 Years
|
0.34%
1/298 • Number of events 1 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.09%
1/1121 • Number of events 1 • Up to 5 Years
|
0.13%
2/1541 • Number of events 2 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
SLE ARTHRITIS
|
0.00%
0/1121 • Up to 5 Years
|
0.06%
1/1541 • Number of events 1 • Up to 5 Years
|
0.00%
0/298 • Up to 5 Years
|
Other adverse events
| Measure |
Standard Therapy
n=1121 participants at risk
Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
|
Remicade
n=1541 participants at risk
Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
|
Switched to Remicade
n=298 participants at risk
Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.7%
41/1121 • Number of events 45 • Up to 5 Years
|
6.5%
100/1541 • Number of events 124 • Up to 5 Years
|
5.0%
15/298 • Number of events 18 • Up to 5 Years
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
5.7%
64/1121 • Number of events 84 • Up to 5 Years
|
9.9%
153/1541 • Number of events 195 • Up to 5 Years
|
6.4%
19/298 • Number of events 23 • Up to 5 Years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
124/1121 • Number of events 153 • Up to 5 Years
|
18.2%
281/1541 • Number of events 376 • Up to 5 Years
|
12.4%
37/298 • Number of events 48 • Up to 5 Years
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER