Trial Outcomes & Findings for Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout (NCT NCT02500641)
NCT ID: NCT02500641
Last Updated: 2019-06-21
Results Overview
Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
196 participants
Primary outcome timeframe
36 weeks of treatment
Results posted on
2019-06-21
Participant Flow
A Run-in/screening period of 1 week (extendable up to a maximum of 30 days to account for variability of serum urate levels) was present prior than randomization.
Participant milestones
| Measure |
Febuxostat 80/120 mg/Day
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
Colchicine: Colchicine 0.5 mg tablets.To prevent flares in
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
|
Overall Study
COMPLETED
|
88
|
86
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Febuxostat 80/120 mg/Day
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
Colchicine: Colchicine 0.5 mg tablets.To prevent flares in
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Unable to follow study procedures
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Sponsor decision
|
1
|
0
|
|
Overall Study
Non compliance to study drug
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Febuxostat 80/120 mg/Day
n=98 Participants
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
n=98 Participants
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
Colchicine: Colchicine 0.5 mg tablets.To prevent flares in
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=98 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=196 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=98 Participants
|
60 Participants
n=98 Participants
|
128 Participants
n=196 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=98 Participants
|
38 Participants
n=98 Participants
|
68 Participants
n=196 Participants
|
|
Age, Continuous
|
58.66 years
STANDARD_DEVIATION 10.83 • n=98 Participants
|
60.52 years
STANDARD_DEVIATION 10.35 • n=98 Participants
|
59.59 years
STANDARD_DEVIATION 10.97 • n=196 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=98 Participants
|
18 Participants
n=98 Participants
|
35 Participants
n=196 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=98 Participants
|
80 Participants
n=98 Participants
|
161 Participants
n=196 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
1 participants
n=98 Participants
|
0 participants
n=98 Participants
|
1 participants
n=196 Participants
|
|
Region of Enrollment
Romania
|
27 participants
n=98 Participants
|
25 participants
n=98 Participants
|
52 participants
n=196 Participants
|
|
Region of Enrollment
Poland
|
38 participants
n=98 Participants
|
52 participants
n=98 Participants
|
90 participants
n=196 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=98 Participants
|
6 participants
n=98 Participants
|
15 participants
n=196 Participants
|
|
Region of Enrollment
Serbia
|
20 participants
n=98 Participants
|
12 participants
n=98 Participants
|
32 participants
n=196 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=98 Participants
|
3 participants
n=98 Participants
|
6 participants
n=196 Participants
|
PRIMARY outcome
Timeframe: 36 weeks of treatmentPopulation: All randomized subjects who had taken at least one dose of study drug specified by treatment group and performed at least one primary efficacy assessment (PWV) after randomization.
Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.
Outcome measures
| Measure |
Febuxostat 80/120 mg/Day
n=92 Participants
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
n=90 Participants
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
Allopurinol 100 up to 600mg/day: Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
Colchicine: Colchicine 0.5 mg tablets.To prevent flares in
|
|---|---|---|
|
Pulse Wave Velocity
|
9.0 m/s
Standard Deviation 2.04
|
9.05 m/s
Standard Deviation 1.99
|
Adverse Events
Febuxostat 80/120 mg/Day
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Allopurinol 100 up to 600 mg/Day
Serious events: 8 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Febuxostat 80/120 mg/Day
n=98 participants at risk
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
n=98 participants at risk
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
|
|---|---|---|
|
Vascular disorders
aortic aneurysm
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Adhesiolysis
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Appendicectomy
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Colectomy
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Coronary artery bypass
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Gastric bypass
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Large intestine operation
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Surgical and medical procedures
Intraocular lens implant
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Injury, poisoning and procedural complications
Post Procedural complication
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Atrial flutter
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Myocardial Ischemia
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Eye disorders
Cataract
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Renal and urinary disorders
Renal impairment
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Infections and infestations
Appendicitis
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
Other adverse events
| Measure |
Febuxostat 80/120 mg/Day
n=98 participants at risk
Febuxostat 80/120 mg film coated tablets.The initial daily dose is 80 mg given orally. In case a patient has serum urate level 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained during the study treatment period.
To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg quaque die (QD ) or in case of colchicine intolerance, Naproxen 550 mg bis in die (BID) with Omeprazole (20-40 mg once daily), if indicated to be used.
|
Allopurinol 100 up to 600 mg/Day
n=98 participants at risk
Allopurinol 100/300 mg tablets.The initial daily allopurinol dose is 100 mg given orally, to be escalated of 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl.
The maximum dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg daily.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD or in case of colchicine intolerance, Naproxen 550 mg BID with Omeprazole (20-40 mg once daily), if indicated to be used.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
General disorders
edema peripheral
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
4/98 • Number of events 4 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood glucose increased
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
4.1%
4/98 • Number of events 4 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood pressure increased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood triglycerides increased
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood uric acid increased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
C-reactive protein increased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
eosinophil count decreased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Heamoglobin decreased
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Hepatic enzyme increased
|
4.1%
4/98 • Number of events 4 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Laboratory test abnormal
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood insulin decreased
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Blood Thyroid stimulating hormone decreased
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Palpitations
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Congenital, familial and genetic disorders
adenomatous polyposis coli
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Congenital, familial and genetic disorders
Type V hyperlipidaemia
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Nervous system disorders
Headache
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Nervous system disorders
sciatica
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Nervous system disorders
Restless legs syndrome
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
8.2%
8/98 • Number of events 8 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
4.1%
4/98 • Number of events 4 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
10/98 • Number of events 18 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
9.2%
9/98 • Number of events 15 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.0%
1/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disk disorder
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
2.0%
2/98 • Number of events 2 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Metabolism and nutrition disorders
gout
|
10.2%
10/98 • Number of events 25 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
15.3%
15/98 • Number of events 27 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
4.1%
4/98 • Number of events 4 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/98 • Number of events 1 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
7.1%
7/98 • Number of events 7 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/98 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
3.1%
3/98 • Number of events 3 • From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.
Adverse event's were considered abnormalities in laboratory analyses (newly occurring after administration or worsening of previously known abnormalities) considered clinically relevant by the Principal investigator (values significantly above or under normal range or requiring an intervention or diagnostic tests or may result in the Investigational Medical Product discontinuation).
|
Additional Information
Post-Registration Clinical Trial Responsible
A. Menarini Industrie Farmaceutiche Riunite SrL
Phone: +39 055 5680459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All data, information, inventions, discoveries, works, results, reports, presentations, intellectual property rights and whatever else arising out of the performance of the activities by PI, shall be of exclusive property of Sponsor or its designee(s). Sponsor shall be free to use the Results for publication or any other purpose, without any further obligations towards PI, and that, unless agreed in writing by Sponsor, PI shall have no right to publish, use or make presentations of the Results.
- Publication restrictions are in place
Restriction type: OTHER