Trial Outcomes & Findings for Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. (NCT NCT01172639)
NCT ID: NCT01172639
Last Updated: 2019-01-22
Results Overview
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
400 participants
Primary outcome timeframe
week 16
Results posted on
2019-01-22
Participant Flow
We recruited 400 participants between January 2009 and May 2013. There were 13 participating Flemish rheumatology centers (2 academic centers, 7 general hospitals and 4 private practices).
There were 379 patients randomised to a treatment arm, 21 patients not randomised: 1 screen failure, 10 withdrawals by subject, 10 randomisation errors
Participant milestones
| Measure |
CoBRA Classic High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Sulfasalazine 2g tablet by mouth, daily for 40 weeks
* Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Slim High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Avant-garde High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40)
* Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40)
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Slim Low Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
Tight Step Up Low Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* No oral steroids allowed during the first year of the trial
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
93
|
43
|
47
|
|
Overall Study
Week 16
|
94
|
96
|
91
|
39
|
47
|
|
Overall Study
Week 52
|
89
|
89
|
88
|
38
|
45
|
|
Overall Study
COMPLETED
|
85
|
87
|
77
|
32
|
41
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
16
|
11
|
6
|
Reasons for withdrawal
| Measure |
CoBRA Classic High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Sulfasalazine 2g tablet by mouth, daily for 40 weeks
* Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Slim High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Avant-garde High Risk Group
* Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40)
* Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40)
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
CoBRA Slim Low Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
|
Tight Step Up Low Risk Group
* Methotrexate 15mg tablet by mouth, weekly for entire trial
* No oral steroids allowed during the first year of the trial
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
11
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
5
|
5
|
0
|
Baseline Characteristics
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Baseline characteristics by cohort
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
Total
n=379 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
51.8 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
51.4 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 14.0 • n=31 Participants
|
51.9 years
STANDARD_DEVIATION 12.9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
262 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
117 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
95 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
371 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
North African
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Smoking status
current
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
97 Participants
n=30 Participants
|
|
Smoking status
past
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
112 Participants
n=30 Participants
|
|
Smoking status
never
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
170 Participants
n=30 Participants
|
|
Symptom duration
|
33.8 weeks
STANDARD_DEVIATION 35.5 • n=99 Participants
|
33.2 weeks
STANDARD_DEVIATION 38.2 • n=107 Participants
|
44.3 weeks
STANDARD_DEVIATION 65.9 • n=206 Participants
|
34.4 weeks
STANDARD_DEVIATION 68.2 • n=7 Participants
|
33.1 weeks
STANDARD_DEVIATION 62.2 • n=31 Participants
|
36.2 weeks
STANDARD_DEVIATION 52.6 • n=30 Participants
|
PRIMARY outcome
Timeframe: week 16Population: ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to DAS28-CRP at Week 16
|
69 Participants
|
72 Participants
|
61 Participants
|
25 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: week 52Population: ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point) DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to DAS28-CRP at Week 52
|
63 Participants
|
57 Participants
|
57 Participants
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: week 104Population: ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints) DAS28-CRP is calculated with the following formula : 0.56\*SQRT TJC28+0.28\*SQRT SJC28+0.36\*ln (CRP+1)+0.014\*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to DAS28-CRP at Week 104
|
64 Participants
|
71 Participants
|
69 Participants
|
29 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: week 16Population: ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to SDAI (Simple Disease Activity Index) at Week 16
|
42 Participants
|
33 Participants
|
44 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: week 52Population: ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to SDAI at Week 52
|
36 Participants
|
27 Participants
|
39 Participants
|
20 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 104Population: ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Remission According to SDAI at Week 104
|
31 Participants
|
28 Participants
|
41 Participants
|
20 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline-week104Population: ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.
Number of patients with a change of \> 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104. A change of \> 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients.
Outcome measures
| Measure |
CoBRA Classic High Risk Group
n=98 Participants
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
|
CoBRA Slim High Risk Group
n=98 Participants
* MTX
* Step down steroid half dose
|
CoBRA Avant-garde High Risk Group
n=93 Participants
* MTX
* Leflunomide
* Step down steroid half dose
|
CoBRA Slim Low Risk Group
n=43 Participants
* MTX
* Step down steroid half dose
|
Tight Step Up Low Risk Group
n=47 Participants
* MTX
* No additional oral steroids allowed
|
|---|---|---|---|---|---|
|
Clinically Significant Change in HAQ Score
|
71 Participants
|
62 Participants
|
64 Participants
|
25 Participants
|
26 Participants
|
Adverse Events
CoBRA Classic High Risk Group
Serious events: 21 serious events
Other events: 85 other events
Deaths: 1 deaths
CoBRA Slim High Risk Group
Serious events: 22 serious events
Other events: 88 other events
Deaths: 1 deaths
CoBRA Avant-garde High Risk Group
Serious events: 16 serious events
Other events: 84 other events
Deaths: 0 deaths
CoBRA Slim Low Risk Group
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Tight Step Up Low Risk Group
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CoBRA Classic High Risk Group
n=98 participants at risk
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim High Risk Group
n=98 participants at risk
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Avant-garde High Risk Group
n=93 participants at risk
* MTX
* Leflunomide
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim Low Risk Group
n=43 participants at risk
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
Tight Step Up Low Risk Group
n=47 participants at risk
* MTX
* No additional oral steroids allowed
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Blood and lymphatic system disorders
Bone marrow supression
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Angina
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Atrioventricular block third degree
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Sinus venosus defect
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Endocrine disorders
Uncontrolled diabetes mellitus
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Volvulus
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Immune system disorders
Anaphylaxis after a wasp sting
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Infections and infestations
Viral infection
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Injury, poisoning and procedural complications
Trauma
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Hernia diaphragmatica
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
1.0%
1/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.2%
3/93 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Ischialgy leg
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis flare
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Infections and infestations
Septic bursitis olecrani
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer malignant
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervixcarcinoma
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrioid adenocarcinoma
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal polyps
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney cancer malignant
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer malignant
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung noduli
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms parotid gland
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Noduli submandibular salivary glands
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Nervous system disorders
Diffuse pain
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Product Issues
Mucositis
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Psychiatric disorders
Severe depression
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Renal and urinary disorders
Bladder infection
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Peribronchitis
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Orthopaedic surgery
|
2.0%
2/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
4/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Abdominal surgery
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Amygdalectomy
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Hysterectomy
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Liposuction arms
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Coronary artery disorder
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Pulmonary embolisms
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Peripheral vascular ischemia
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
Other adverse events
| Measure |
CoBRA Classic High Risk Group
n=98 participants at risk
* Methotrexate (MTX)
* Sulphasalazine
* Step down steroid full dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim High Risk Group
n=98 participants at risk
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Avant-garde High Risk Group
n=93 participants at risk
* MTX
* Leflunomide
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
CoBRA Slim Low Risk Group
n=43 participants at risk
* MTX
* Step down steroid half dose
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
Tight Step Up Low Risk Group
n=47 participants at risk
* MTX
* No additional oral steroids allowed
randomisation: Stratification according to risk factors into two groups. Random assignment to different treatment strategies within strata.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
28.6%
28/98 • Number of events 50 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
42.9%
42/98 • Number of events 72 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
31.2%
29/93 • Number of events 46 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
32.6%
14/43 • Number of events 29 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
38.3%
18/47 • Number of events 40 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Abdominal pain
|
25.5%
25/98 • Number of events 27 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
23.5%
23/98 • Number of events 26 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
39.8%
37/93 • Number of events 46 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
25.6%
11/43 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
19.1%
9/47 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Hepatobiliary disorders
Liver function disturbance
|
17.3%
17/98 • Number of events 22 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
15.3%
15/98 • Number of events 19 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
25.8%
24/93 • Number of events 25 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
14.0%
6/43 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.8%
6/47 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.3%
15/98 • Number of events 15 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.1%
7/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.9%
12/93 • Number of events 13 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
11.6%
5/43 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Nausea
|
15.3%
15/98 • Number of events 16 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
21.4%
21/98 • Number of events 25 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.9%
12/93 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
23.3%
10/43 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
23.4%
11/47 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
12/98 • Number of events 13 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
19.4%
19/98 • Number of events 22 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
14.0%
13/93 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
19.1%
9/47 • Number of events 13 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Nervous system disorders
Headache
|
12.2%
12/98 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.1%
6/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.7%
9/93 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Nervous system disorders
Vertigo
|
11.2%
11/98 • Number of events 11 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.1%
7/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.3%
4/43 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
9.2%
9/98 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.2%
10/98 • Number of events 10 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
21.5%
20/93 • Number of events 23 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
9/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
13.3%
13/98 • Number of events 14 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.5%
7/93 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
General malaise
|
9.2%
9/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.4%
5/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Hypertension
|
9.2%
9/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.2%
8/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
14.0%
13/93 • Number of events 13 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.3%
4/43 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Blood and lymphatic system disorders
Anaemia
|
8.2%
8/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.4%
5/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
2/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Gastroenteritis
|
8.2%
8/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.2%
8/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.6%
8/93 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
18.6%
8/43 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Insomnia
|
8.2%
8/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Cardiac disorders
Palpitations
|
8.2%
8/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
2/47 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
7/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
4/93 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Fatigue
|
7.1%
7/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
4/93 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Hairloss
|
7.1%
7/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.2%
12/98 • Number of events 13 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
20.4%
19/93 • Number of events 20 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
16.3%
7/43 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.8%
6/47 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Increased transpiration
|
7.1%
7/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Nervous system disorders
Paresthesia
|
7.1%
7/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.2%
8/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.5%
7/93 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Agitation
|
6.1%
6/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.8%
10/93 • Number of events 10 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Flushes
|
6.1%
6/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Eye disorders
Eye infection
|
6.1%
6/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.4%
5/93 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
6.1%
6/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.1%
5/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.4%
5/93 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff lesion
|
6.1%
6/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Injury, poisoning and procedural complications
Trauma
|
6.1%
6/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Renal and urinary disorders
Urinary tract infection
|
6.1%
6/98 • Number of events 7 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.5%
7/93 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
5/98 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
11.2%
11/98 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
25.8%
24/93 • Number of events 28 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Infections and infestations
Influenza infection
|
5.1%
5/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.2%
10/98 • Number of events 10 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.8%
10/93 • Number of events 10 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.5%
4/47 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.2%
9/98 • Number of events 11 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
12.9%
12/93 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.3%
4/43 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Tendinopathy
|
5.1%
5/98 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
9.2%
9/98 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
11.8%
11/93 • Number of events 12 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
11.6%
5/43 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
2/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Gastrointestinal disorders
Pyrosis
|
5.1%
5/98 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.1%
7/98 • Number of events 8 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.2%
2/93 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Infections and infestations
Aphtosis
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.6%
8/93 • Number of events 10 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Reproductive system and breast disorders
Genital infection
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.6%
8/93 • Number of events 9 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.3%
1/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
2/47 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
General disorders
Sjogren's disease
|
5.1%
5/98 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Venous insufficiency
|
4.1%
4/98 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.1%
5/98 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.5%
6/93 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.2%
3/93 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.3%
2/47 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Surgical and medical procedures
Tooth extraction
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/47 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
4/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.1%
3/98 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
5.4%
5/93 • Number of events 5 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Renal and urinary disorders
Renal insufficiency
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
2.0%
2/98 • Number of events 2 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
3.2%
3/93 • Number of events 4 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
8.5%
4/47 • Number of events 6 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
|
Vascular disorders
Syncope
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/98 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/93 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
0.00%
0/43 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected over a two year period per patient
All adverse events were registered by healthcare professionals questioning the patients at each visit
|
Additional Information
Prof. Dr. Patrick Verschueren
University Hospitals Leuven
Phone: +32 16 34 25 41
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place