Trial Outcomes & Findings for Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012 (NCT NCT00356590)
NCT ID: NCT00356590
Last Updated: 2013-05-14
Results Overview
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
468 participants
Primary outcome timeframe
Up to 8 years
Results posted on
2013-05-14
Participant Flow
Participants were enrolled from 3 March 1999 through 17 Mar 2000
Participant milestones
| Measure |
Etanercept (Enbrel)
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Overall Study
STARTED
|
468
|
|
Overall Study
COMPLETED
|
194
|
|
Overall Study
NOT COMPLETED
|
274
|
Reasons for withdrawal
| Measure |
Etanercept (Enbrel)
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Overall Study
Adverse Event
|
54
|
|
Overall Study
Death
|
10
|
|
Overall Study
Lost to Follow-up
|
35
|
|
Overall Study
Physician Decision
|
46
|
|
Overall Study
Withdrawal by Subject
|
41
|
|
Overall Study
Completed month 12 only
|
2
|
|
Overall Study
Protocol issues
|
6
|
|
Overall Study
Response status
|
28
|
|
Overall Study
Other
|
52
|
Baseline Characteristics
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
Baseline characteristics by cohort
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Age Continuous
|
51.38 Year
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
351 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
25 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
407 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participant
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participant
n=5 Participants
|
|
Physician Global Assessment of Disease Status
|
5.32 Units on a scale
STANDARD_DEVIATION 2.30 • n=5 Participants
|
|
Participant Global Assessment of Disease Status
|
5.51 Units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
|
Participant Pain Visual Analog Scale
|
5.01 Units on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
|
Tender Joint Count
|
25.81 Joints
STANDARD_DEVIATION 16.71 • n=5 Participants
|
|
Swollen Joint Count
|
20.30 Joints
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Health Assessment Questionnaire Disability Index
|
1.30 Units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
|
Physical Component Summary Score from SF-36
|
30.42 Units on a scale
STANDARD_DEVIATION 9.69 • n=5 Participants
|
|
Mental Component Summary Score from SF-36
|
48.28 Units on a scale
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
C-Reactive Protein
|
3.28 mg/dL
STANDARD_DEVIATION 4.90 • n=5 Participants
|
|
Duration of Morning Stiffness
|
182.24 Minutes
STANDARD_DEVIATION 286.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure to Etanercept With Gaps
|
2882.50 Participant-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure-Adjusted Rate of Malignancies
|
1.32 Malignancies per 100 participant-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure-Adjusted Rate of Deaths
|
0.35 Deaths per 100 participant-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure Adjusted Rate of Serious Infectious Events
|
2.88 Events per 100 participant-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure Adjusted Rate of Lymphomas
|
0.24 Lymphomas per 100 participant-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Malignancy
|
31 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Lymphoma
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Serious Infectious Event
|
51 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Total Exposure Adjusted Rate of Serious Adverse Events
|
13.84 Events per 100 patient-years
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: All enrolled participants who received at least one dose of etanercept
Death of the participant on study up to 30 days after the last dose of etanercept
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Death
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline and month 3Population: All enrolled participants who received at least one dose of etanercept and had available data at month 3
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
Outcome measures
| Measure |
Etanercept (Enbrel)
n=450 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
ACR20 Response at Month 3
|
276 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: All participants who received at least one dose of etanercept
Duration of etanercept dosing
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Dosing Period
|
2249.6 Days
Standard Deviation 1180.00
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Outcome measures
| Measure |
Etanercept (Enbrel)
n=424 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
ACR20 Response at Month 12
|
262 Participants
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Outcome measures
| Measure |
Etanercept (Enbrel)
n=424 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
ACR50 Response at Month 12
|
192 Participants
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Outcome measures
| Measure |
Etanercept (Enbrel)
n=424 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
ACR70 Response at Month 12
|
110 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: All participants who received at least one dose of etanercept
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=468 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Standardized Incidence Rate for All SEER Cancers
|
0.99 Standardized incidence rate
Interval 0.67 to 1.42
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Outcome measures
| Measure |
Etanercept (Enbrel)
n=417 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
|
50.07 Percent change
Standard Deviation 58.07
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Outcome measures
| Measure |
Etanercept (Enbrel)
n=419 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
|
35.46 Percent change
Standard Deviation 60.62
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
Outcome measures
| Measure |
Etanercept (Enbrel)
n=422 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
|
30.64 Percent change
Standard Deviation 103.25
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=417 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Tender Joint Count From Baseline to Month 12
|
49.70 Percent change
Standard Deviation 147.16
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=412 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Swollen Joint Count From Baseline to Month 12
|
52.04 Percent change
Standard Deviation 87.97
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=420 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in HAQ DI From Baseline to Month 12
|
40.91 Percent change
Standard Deviation 66.09
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=422 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
|
-39.65 Percent change
Standard Deviation 55.43
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=422 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
|
-12.31 Percent change
Standard Deviation 31.48
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in C-reactive protein from baseline to month 12
Outcome measures
| Measure |
Etanercept (Enbrel)
n=423 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in C-Reactive Protein From Baseline to Month 12
|
31.57 Percent change
Standard Deviation 132.83
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
Percent improvement in the duration of morning stiffness from baseline to month 12
Outcome measures
| Measure |
Etanercept (Enbrel)
n=411 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
|
44.08 Percent change
Standard Deviation 156.20
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=274 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Change From Baseline to Year 2 in Total Sharp Score
|
1.17 Units on a scale
Interval -10.1 to 32.72
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=274 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
|
0.54 Units on a scale
Interval -8.08 to 20.83
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
Outcome measures
| Measure |
Etanercept (Enbrel)
n=274 Participants
Etanercept 50 mg subcutaneous dose weekly
|
|---|---|
|
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
|
0.64 Units on a scale
Interval -5.04 to 16.31
|
Adverse Events
Enbrel
Serious events: 169 serious events
Other events: 320 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enbrel
n=468 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina pectoris
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Angina unstable
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
7/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
5/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
6/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
8/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Palpitations
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Pericarditis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Myxoedema
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diverticulum
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Adverse drug reaction
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
1.9%
9/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Condition aggravated
|
2.4%
11/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Death
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Impaired healing
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
5/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Anaphylactic shock
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abdominal abscess
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Abscess
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Anorectal infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Appendicitis perforated
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Arthritis bacterial
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
1.3%
6/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis bacterial
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bursitis infective
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
1.3%
6/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cholecystitis infective
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cystitis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diarrhoea infectious
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Empyema
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Haemophilus sepsis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Localised infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Orchitis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pelvic abscess
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Perirectal abscess
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Peritonsillar abscess
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
3.2%
15/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia escherichia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Post procedural infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pseudomonas infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pyelonephritis
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pyelonephritis acute
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Streptococcal infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urosepsis
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Viral infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Wound infection
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Biopsy prostate
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Colonoscopy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Obesity
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
8/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.3%
6/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage II
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic lymphoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
5/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell chronic lymphocytic leukaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
5/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Multiple sclerosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Myelopathy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Adjustment disorder
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Conversion disorder
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal mass
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.43%
2/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Cystopexy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Incisional hernia repair
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.85%
4/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Surgery
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Aortic aneurysm
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Arterial thrombosis
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haemorrhage
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Lymphoedema
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.21%
1/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Thrombosis
|
0.64%
3/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Enbrel
n=468 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
28/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
26/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
5.6%
26/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site erythema
|
10.9%
51/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site pruritus
|
5.6%
26/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site swelling
|
5.3%
25/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
10.5%
49/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cystitis
|
5.8%
27/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Influenza
|
9.0%
42/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
19.4%
91/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.6%
106/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
9.8%
46/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
5.8%
27/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
36/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
5.1%
24/468 • Up to 9.57 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER