Trial Outcomes & Findings for Efficacy and Safety of Deferasirox in Patients With Chronic Anemia and Transfusional Hemosiderosis (NCT NCT00631163)
NCT ID: NCT00631163
Last Updated: 2021-06-29
Results Overview
Liver iron concentration (LIC), a predictor of iron burden, was measured using relaxation rate magnetic resonance imaging (R2-MRI) technique. Relaxation rate was determined as R2 = 1/relaxation time (T2). The baseline value of LIC of participants was categorized as \< 7, ≥ 7 to \< 15, and ≥ 15 milligram of iron/tissue dry weight (mg Fe/g dw). A negative change from baseline favored study treatment in reducing LIC.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
From the Baseline, Year 1 (End of core study)
Results posted on
2021-06-29
Participant Flow
The study was conducted at 31 centers and five countries.
A total of 144 Participants were screened, of which only 102 Participants enrolled in the study. Remaining 42 Participants were considered as screen failures.
Participant milestones
| Measure |
Deferasirox
Participants received initial dose of 20 milligrams per kilogram (mg/kg) Deferasirox tablets was administered orally once daily (OD) based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|
|
Number of Participants in Year 1
STARTED
|
102
|
|
Number of Participants in Year 1
COMPLETED
|
68
|
|
Number of Participants in Year 1
NOT COMPLETED
|
34
|
|
Number of Participants in Year 2
STARTED
|
57
|
|
Number of Participants in Year 2
COMPLETED
|
52
|
|
Number of Participants in Year 2
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Deferasirox
Participants received initial dose of 20 milligrams per kilogram (mg/kg) Deferasirox tablets was administered orally once daily (OD) based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|
|
Number of Participants in Year 1
Adverse Event
|
12
|
|
Number of Participants in Year 1
Withdrawal by Subject
|
8
|
|
Number of Participants in Year 1
Death
|
6
|
|
Number of Participants in Year 1
Lost to Follow-up
|
1
|
|
Number of Participants in Year 1
Patient's condition no longer requires study drug
|
1
|
|
Number of Participants in Year 1
Administrative problems
|
6
|
|
Number of Participants in Year 2
Withdrawal by Subject
|
2
|
|
Number of Participants in Year 2
Adverse Event
|
1
|
|
Number of Participants in Year 2
Protocol Violation
|
1
|
|
Number of Participants in Year 2
Abnormal laboratory value
|
1
|
Baseline Characteristics
Efficacy and Safety of Deferasirox in Patients With Chronic Anemia and Transfusional Hemosiderosis
Baseline characteristics by cohort
| Measure |
Deferasirox
n=102 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 25.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the Baseline, Year 1 (End of core study)Population: The analysis was performed in per-protocol population in core study (PP1 Set), comprising of all enrolled participants who had LIC assessments at baseline and Year 1.
Liver iron concentration (LIC), a predictor of iron burden, was measured using relaxation rate magnetic resonance imaging (R2-MRI) technique. Relaxation rate was determined as R2 = 1/relaxation time (T2). The baseline value of LIC of participants was categorized as \< 7, ≥ 7 to \< 15, and ≥ 15 milligram of iron/tissue dry weight (mg Fe/g dw). A negative change from baseline favored study treatment in reducing LIC.
Outcome measures
| Measure |
Deferasirox
n=50 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Absolute Change From Baseline in Liver Iron Concentration (LIC) to Year 1
|
-10.9 mg Fe/g dw
Standard Deviation 11.86
|
—
|
SECONDARY outcome
Timeframe: From the Baseline to End of Year 2 (End of extension study)Population: The analysis was performed in per-protocol population in core study (PP2 Set), comprising of all enrolled participants who had LIC assessments at baseline and at end of the extension phase.
Liver Iron Concentration (LIC), a predictor of iron burden, was measured using R2-MRI technique. Relaxation rate was determined as R2 = 1/T2. The baseline value of LIC of participants was categorized as \< 7, ≥ 7 to \< 15, and ≥ 15 mg Fe/g dw. A negative change from baseline favoured study treatment in reducing LIC.
Outcome measures
| Measure |
Deferasirox
n=41 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Absolute Change From Baseline in Liver Iron Concentration (LIC) to End of Year 2
|
-13.5 mg Fe/g dw
Standard Deviation 14.10
|
—
|
SECONDARY outcome
Timeframe: From the Baseline, End of Year 1 (End of core study), End of Year 2 (End of extension study)Population: The analysis was performed in PP1 set in Japanese subgroup defined as all participants who were enrolled in Japan for core study (Year 1) and PP2 set in Japanese subgroup for extension study (Year 2). Here, 'n' signifies the participants reviewed for Liver Iron Concentration (LIC) in Japanese subgroup for each group, respectively.
Liver Iron Concentration (LIC), a predictor of iron burden, was measured using R2-MRI technique. Relaxation rate was determined as R2 = 1/T2. The baseline value of LIC was \< 7, ≥ 7 to \< 15, and ≥ 15 mg Fe/g dw. A negative change from baseline favoured study treatment in reducing LIC.
Outcome measures
| Measure |
Deferasirox
n=57 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Absolute Change From Baseline in Liver Iron Concentration (LIC) in Japanese Subgroup
Year 1
|
-13.9 mg Fe/g dw
Standard Deviation 10.21
|
—
|
|
Absolute Change From Baseline in Liver Iron Concentration (LIC) in Japanese Subgroup
Year 2
|
-18.4 mg Fe/g dw
Standard Deviation 12.48
|
—
|
SECONDARY outcome
Timeframe: From the Baseline up to Year 2 (End of extension study)Population: The analysis was performed in PP2 Set population and Japanese subgroup. Here, "Number of subjects analyzed" signifies the participants assessed for serum ferritin during the study for each arm, respectively.
Serum ferritin was a marker for the monitoring of chelation therapy. Ferritin protein stores iron and provides overall iron levels, higher ferritin in blood showed more iron content.
Outcome measures
| Measure |
Deferasirox
n=102 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
n=53 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Absolute Change From Baseline in Serum Ferritin Levels to Year 2
|
-677.9 nanogram(s)/millilitre
Standard Deviation 4462.11
|
-892.8 nanogram(s)/millilitre
Standard Deviation 5724.89
|
SECONDARY outcome
Timeframe: From the Baseline, Year 1 (End of core study), Year 2 (End of extension study)Population: The analysis was performed in PP1 set population for core study (Year 1) and PP2 set population for extension study (Year 2) and Japanese subgroup. Here, "Number of participants analysed" signifies the subjects assessed for serum ferritin during the study for each arm, respectively.
Serum ferritin was a marker for the monitoring of chelation therapy. Ferritin protein stores iron and provides overall iron levels, higher ferritin in blood showed more iron content.
Outcome measures
| Measure |
Deferasirox
n=50 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
n=31 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Absolute Serum Ferritin Levels Over 2 Years
Year 1
|
2653.3 nanogram(s)/millilitre
Standard Deviation 2952.07
|
2903.5 nanogram(s)/millilitre
Standard Deviation 3376.00
|
|
Absolute Serum Ferritin Levels Over 2 Years
Year 2
|
2092.4 nanogram(s)/millilitre
Standard Deviation 2287.11
|
2114.8 nanogram(s)/millilitre
Standard Deviation 2391.31
|
SECONDARY outcome
Timeframe: From the Baseline, Year 2 (End of extension study)Population: The analysis was performed in PP2 set population and Japanese/tim subgroup. Here, "Number of participants analyzed" included all participants who were evaluable for the specified categories.
Total body iron excretion (TBIE)was used to investigate the chelation efficacy of Deferasirox therapy. TBIE rate was estimated based on the iron influx as determined by the amount of red cells transfused and the change in total body iron (TBI) stores.
Outcome measures
| Measure |
Deferasirox
n=41 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
n=26 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Total Body Iron Elimination Rate (TBIE), Iron Intake, Iron Excretion/Iron Intake and Chelation Efficiency After 2 Years
TBIE
|
0.46 mg/kg/day
Standard Deviation 0.252
|
0.54 mg/kg/day
Standard Deviation 0.215
|
|
Total Body Iron Elimination Rate (TBIE), Iron Intake, Iron Excretion/Iron Intake and Chelation Efficiency After 2 Years
Iron intake
|
0.27 mg/kg/day
Standard Deviation 0.150
|
0.27 mg/kg/day
Standard Deviation 0.160
|
|
Total Body Iron Elimination Rate (TBIE), Iron Intake, Iron Excretion/Iron Intake and Chelation Efficiency After 2 Years
Iron excretion/iron intake
|
2.00 mg/kg/day
Standard Deviation 1.368
|
2.44 mg/kg/day
Standard Deviation 1.417
|
|
Total Body Iron Elimination Rate (TBIE), Iron Intake, Iron Excretion/Iron Intake and Chelation Efficiency After 2 Years
Chelation efficiency
|
0.40 mg/kg/day
Standard Deviation 0.221
|
0.50 mg/kg/day
Standard Deviation 0.177
|
SECONDARY outcome
Timeframe: From the Baseline, Year 1 (End of core study), Year 2 (End of extension study)Population: The analysis was performed in PP1 set for core study (Year 1) and PP2 set for extension study (Year 2). Here, "Number of subjects analysed" signifies the subjects assessed for LIC and serum ferritin during the study for each arm, respectively.
LIC, a predictor of iron burden, was measured using R2-MRI technique. Relaxation rate was determined as R2 = 1/T2. The baseline value of LIC was \< 7, ≥ 7 to \< 15, and ≥ 15 mg Fe/g dw. Serum ferritin was a marker for the monitoring of chelation therapy. Ferritin protein stores iron and provides overall iron levels, higher ferritin in blood showed more iron content. The correlation between absolute change in LIC and absolute change in serum ferritin was determined.
Outcome measures
| Measure |
Deferasirox
n=50 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
n=40 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Correlation of LIC and Serum Ferritin at Core and Extension Study
|
0.291 Correlation coefficient
|
0.325 Correlation coefficient
|
SECONDARY outcome
Timeframe: From the Baseline up to Year 2 (End of extension study)Population: The analysis was performed in the safety set (SAF) population, defined as subjects who received at least one dose of study drug, which was defined as at least one administration record with a valid date and an actual total daily dose administrated above zero, and Japanese sub-group.
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. Death was defined as a fatal event leading to permanent cessation of all vital functions of the body.
Outcome measures
| Measure |
Deferasirox
n=102 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Adverse Events
|
97 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Serious Adverse Events (SAE)
|
46 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Serious Adverse Events (SAE) with suspected relationship to study drug
|
10 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Death
|
6 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Adverse event leading to discontinuation of study drug
|
14 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Adverse event leading to dose adjustment/interruption
|
67 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Adverse Event of Special Interest (AESI)
|
62 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Discontinuation and Interruption
Adverse Event With Suspected Relationship to Study drug
|
65 participants
|
—
|
SECONDARY outcome
Timeframe: At 2 years (End of extension study)Population: The analysis was performed in the SAF population, defined as subjects who received at least one dose of study drug, which was defined as at least one administration. These participants comprise 2 year completer groups
Clinically significant changes in left eye and right eye were assessed by the investigator based on methods like visual acuity, slit lamp examination, tonometry and fundus oculi.
Outcome measures
| Measure |
Deferasirox
n=50 Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
Japanese Participants
Participants received initial dose of 20 mg/kg Deferasirox tablets was administered orally OD based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
|
|---|---|---|
|
Number of Participants With Clinically Significant Ophthalmological Abnormalities
Not Available
|
3 participants
|
—
|
|
Number of Participants With Clinically Significant Ophthalmological Abnormalities
Normal
|
24 participants
|
—
|
|
Number of Participants With Clinically Significant Ophthalmological Abnormalities
Abnormal, Clinically Insignificant
|
14 participants
|
—
|
|
Number of Participants With Clinically Significant Ophthalmological Abnormalities
Abnormal, Clinically Significant
|
9 participants
|
—
|
|
Number of Participants With Clinically Significant Ophthalmological Abnormalities
Total
|
50 participants
|
—
|
Adverse Events
Myelodysplastic Syndrome
Serious events: 22 serious events
Other events: 39 other events
Deaths: 2 deaths
Aplastic Anemia
Serious events: 14 serious events
Other events: 25 other events
Deaths: 3 deaths
Other
Serious events: 10 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Myelodysplastic Syndrome
n=42 participants at risk
A group of disorders caused when something disrupts the production of blood cells.
|
Aplastic Anemia
n=29 participants at risk
Aplastic anemia is a condition that occurs when your body stops producing enough new blood cells. The condition leaves you fatigued and more prone to infections and uncontrolled bleeding.
|
Other
n=31 participants at risk
Very rare diseases (e.g. Diamond Blackfan anemia, myelofibrosis, specific enzyme deficiency).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
APLASTIC ANAEMIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
CARDIAC FAILURE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
PERICARDITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Endocrine disorders
DELAYED PUBERTY
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ASCITES
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
PERIODONTITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
RADICULAR CYST
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
CHEST DISCOMFORT
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
DISUSE SYNDROME
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
FATIGUE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
GENERALISED OEDEMA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
MALAISE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
MULTI-ORGAN FAILURE
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
PYREXIA
|
14.3%
6/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
BACTERIAL INFECTION
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
BRONCHITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
FUNGAEMIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
FUNGAL OESOPHAGITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
GASTRITIS VIRAL
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
HERPES ZOSTER
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
INFECTION
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
ORAL HERPES
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
PERTUSSIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
PHARYNGITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
PNEUMONIA
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
SEPSIS
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
SEPTIC SHOCK
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
ZYGOMYCOSIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
BODY HEIGHT BELOW NORMAL
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
BONE SWELLING
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ABDOMINAL NEOPLASM
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELOFIBROSIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
CEREBELLAR HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
DIZZINESS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
NEUROSIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
FANCONI SYNDROME ACQUIRED
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
ADENOIDAL HYPERTROPHY
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
PANNICULITIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Myelodysplastic Syndrome
n=42 participants at risk
A group of disorders caused when something disrupts the production of blood cells.
|
Aplastic Anemia
n=29 participants at risk
Aplastic anemia is a condition that occurs when your body stops producing enough new blood cells. The condition leaves you fatigued and more prone to infections and uncontrolled bleeding.
|
Other
n=31 participants at risk
Very rare diseases (e.g. Diamond Blackfan anemia, myelofibrosis, specific enzyme deficiency).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.9%
5/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
APLASTIC ANAEMIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
CARDIAC FAILURE
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
TACHYCARDIA
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
EYE PAIN
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
7/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
31.0%
13/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
17.2%
5/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
23.8%
10/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
24.1%
7/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
16.1%
5/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTRITIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
NAUSEA
|
21.4%
9/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
20.7%
6/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
STOMATITIS
|
19.0%
8/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
24.1%
7/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
VOMITING
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
ASTHENIA
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
CHEST PAIN
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
FACE OEDEMA
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
FATIGUE
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
MALAISE
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
14/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
24.1%
7/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
PYREXIA
|
26.2%
11/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
31.0%
9/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
19.4%
6/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
BRONCHITIS
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
12.9%
4/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
CYSTITIS
|
11.9%
5/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
HERPES SIMPLEX
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
HERPES ZOSTER
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
INFLUENZA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
33.3%
14/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
34.5%
10/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
19.4%
6/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
OTITIS MEDIA CHRONIC
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
PHARYNGITIS
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
TONSILLITIS
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
29.0%
9/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
14.3%
6/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
FALL
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
BLOOD CREATININE INCREASED
|
38.1%
16/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
27.6%
8/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
17.2%
5/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
PROTEIN URINE PRESENT
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
16.1%
5/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
WEIGHT DECREASED
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.7%
7/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
11.9%
5/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
7/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
11.9%
5/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
DYSGEUSIA
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
HEADACHE
|
19.0%
8/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
9.7%
3/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
SOMNOLENCE
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
DELIRIUM
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
INSOMNIA
|
14.3%
6/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
PROTEINURIA
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
RENAL FAILURE
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
9.5%
4/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
20.7%
6/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
16.1%
5/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.4%
1/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.4%
1/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
12.9%
4/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
MADAROSIS
|
0.00%
0/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
7.1%
3/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
13.8%
4/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
26.2%
11/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
10.3%
3/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
3.2%
1/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.5%
2/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
HYPOTENSION
|
4.8%
2/42 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
6.9%
2/29 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
0.00%
0/31 • From the Baseline up to Year 2 (End of extension study)
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place